Showing posts with label Investment News HCV Drugs. Show all posts
Showing posts with label Investment News HCV Drugs. Show all posts

Friday, December 17, 2010

Hepatitis C:Vertex close to commercializing telaprevir, what about Boceprevir?



This blog has kept an updated digest pertaining to HCV drug investments on Wall Street. Often the articles on these investment sites are insightful with a quick easy read.


Today Morning Star had a little update for their investors on the much anticipated drug telaprevir. In their article written by Lauren Migliore entitled "Three Upcoming Make-or-Break Biotech Approvals" Vertex's drug Telaprevir has been deemed as the winner in the New HCV drug market. The predicition was Telaprevir will most likely take first prize over Merck's boceprevir. Who knew?. Me and YOU !


Quoted From The Article.......
"Vertex (NasdaqGS:VRTX - News) is close to commercializing its hepatitis C drug telaprevir, part of a new class of therapies that have the potential to revolutionize the way the disease is treated"

"Vertex's chief rival, Merck (NYSE:MRK - News), is developing a protease inhibitor of its own. We think telaprevir's slightly superior efficacy and convenience profile should give it an advantage with prescribers. However, Vertex has no commercialization experience, and Merck's established salesforce and ability to package the drug with the current standard of care should help even the commercialization playing field. Vertex ranked number 1 on our 2010 biotech takeout list, and we continue to believe the firm would benefit from the sales know-how of a larger pharma player like current partner Johnson & Johnson (NYSE:JNJ - News)."



Related Articles On The Blog:





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Tuesday, December 7, 2010

Vertex Webcast Today Dec 7th

CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Vertex Pharmaceuticals Incorporated today announced that it will webcast its presentation at the NASDAQ OMX Investor Conference in London on Tuesday, December 7, 2010 at 8:30 a.m. GMT (3:30 a.m. ET).

The presentation will be webcast live and may be accessed from ‘Events & Presentations’ on the home page of Vertex’s website at www.vrtx.com. A replay of the webcast will also be available on the Company’s website for two weeks following the presentation. To ensure a timely connection, it is recommended that users register at least 15 minutes prior to the scheduled webcast.

Subscribe: http://www.fiercebiotech.com/signup?sourceform=Viral-Tynt-FierceBiotech-FierceBiotech

Tuesday, November 23, 2010

Roche terminates agreement: Prohibited to develop related compounds for 10 yrs

UPDATE 1-Ligand Pharma says Roche terminates agreement

* Roche prohibited to develop related compounds for 10 yrs

Nov 23 (Reuters) - Ligand Pharmaceuticals Inc (LGNDD.O) said Swiss drugmaker Roche Holding AG (ROG.VX) was exercising its right to terminate the collaboration and license agreement between the two companies on developing hepatitis C treatment.
The collaboration and license agreement with Roche began in 2008 to develop new treatments for hepatitis C viral infection using liver-targeting technology.
In April, Ligand received $6.5 million milestone payment from Roche.
As per the agreement, Ligand will receive a non-exclusive, worldwide, royalty-bearing license under specified Roche patents to develop, make and sell related compounds and products, subject to royalty payments on net sales.
Roche will be prohibited for ten years following the termination from developing or commercializing related compounds, Ligand said in a regulatory filing.
Continue reading...........

Monday, November 22, 2010

Hepatitis C On Wall Street: The Scandals Nov 22 2010



November 22, 2010 11:49 am

, The latest insider trading investigation is focusing on the new hub of Wall Street information: independent research networks that pay so-called experts for information on public companies.
What is it with Wall Street these days that it won't let a record stand for the usual amount of time?

First, Marc Dreier gets one-upped by Bernie Madoff. Then, Bear Stearns gets bested by Lehman Brothers. And now the Galleon insider trading scandal—only a year old!—looks like it's going to get dusted by the latest insider trading probe on Wall Street.

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But three years into the program, the man who is at the center of an insider trading case involving FrontPoint Partners and French doctor who allegedly tipped the firm off, packed up and left. In the same year, Chip Skowron joined SAC Capital, and his Wall Street career began.

.U.S. Is Said to Pursue Broad Insider Trading Case
By PETER LATTMAN
Authorities are at an advanced stage of an insider-trading investigation that could result in criminal charges against Wall Street traders, a government official said.

November 20, 2010
While Waksal is famous for his contributions to ImClone; he is infamous for his stint in jail after an insider trading scandal involving homemaking guru Martha Stewart erupted in 2002.--Lisa LaMotta

Former ImClone Systems Chief Executive Sam Waksal’s new biotech Kadmon Pharmaceuticals has officially emerged from stealth mode, purchasing privately-held Three Rivers Pharmaceuticals in a mostly cash deal that is rumored to be worth more than $100 million. Three Rivers will serve as the commercial and operational cornerstone of Kadmon, which is focused on oncology, infectious disease, and immunology. The new biotech has raised over $200 million in debt and equity from investors in Japan and China. Three Rivers will contribute a portfolio of three marketed hepatitis C treatments including Infergen, Ribasphere, and RibaPak, as well as the fungal treatment Amphotec. Kadmon is expected to keep the Three Rivers headquarters in Warrendale, Pa. and its manufacturing plant. Waksal hopes to follow up on the success of ImClone, which was acquired by Eli Lilly in 2008 for $6.5 billion.

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In Case You Missed It

It's all legal until a line is crossed where the doctor shares confidential or insider information with the investor. In fact, at just about every medical meeting held around the world, a select group of doctors -- often the thought leaders of their respective fields -- excuse themselves from presenting new clinical data or networking with colleagues and make their way to hotel meeting rooms to consult for Wall Street investors.


Updated Daily On The Blog


Wednesday, November 10, 2010

83.8% Of Doctors Have Some Sort Of Connection W-Drug Companies

Norman Rockwell
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Days gone by. As I sit here reading an article at medical news today reporting that 83.8% of doctors have some sort of relationship with drug companies; I'm recalling childhood impressions of my own family doctor. Yes, my doctor even made house calls which included a phone call to my mother a few hours later. Now that was admirable follow up care. Days gone by.

I don't mean to be redundant but lately there has been a few instances reported in relation to physicians crossing the line with unethical behavior, to say the least. In November according to a report from Australia Roche was fined for offering money to a nurse working at a undisclosed clinic. Kate Hagan from age.com writes "Drug company Roche has been fined $200,000 for offering to fund a nurse's position at a health service - depending on how many patients were treated with its hepatitis C drug Pegasys"The drug company has two fines under (two different occasions) the Medicines Australia code of conduct for the maximum of 200,000 dollars.

A few weeks ago a French doctor working as a consultant for "Human Genome Sciences Inc. was charged by the U.S. with insider-trading for allegedly tipping off a hedge fund about negative results of Albuferon drug trials."

In October Sam Waksal, the former CEO of ImClone Systems, whose insider trading lead to spending time in prison along with Martha Stewart, remember? Announced a new enterprise; "Waksal said his drug company Kadmon Pharmaceuticals has bought the privately held Three Rivers Pharmaceuticals, and that its treatments for hepatitis C, infections and cancer will be the backbone of his new enterprise".

Let's not forget the list published on the 384 doctors and healthcare professionals who were paid by pharmaceutical companies to promote their drugs. They "Drew Payments From Drug Companies" for the amount of no less then $100,000 published @ ProPublicas website: This list covered "Top Earners from 2009 and early 2010"

ProPublica writes ;"We obtained information on government actions, which include sanctions and warnings, from the websites of state medical boards and the U.S. Food and Drug Administration. Some states remove older discipline from their web sites."
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NPR ran an interview that I found to be insightful (including audio) with Charles Ornstein, discussing the ProPublica list, Titled "Drug Companies Hire Troubled Doctors As Experts". Quote from NPR; "Although these companies have posted payments on their websites — some as a result of legal settlements — they make it difficult to spot trends or even learn who has earned the most. ProPublica combined the data and identified the highest-paid doctors, then checked their credentials and disciplinary records. Pfizer, one of the largest drug makers in the U.S., saw $27.8 billion in sales in 2009. Seven drug companies, including Pfizer, have disclosed information about doctors who receive payment for speaking fees related to products they sell". Audio/Full Story.

This brings us to another update published today at "Medical News Today". The article adds to the coverage between these doctors and those drug companies with an update from JAMA. The website pointed out the "Journal of the American Medical Association" would like to see "A national system of disclosure which openly reveals doctor-industry ties "The article quoted JAMA authors response to the "83.8% of doctors self-reporting some kind of relationship with drug and medical device companies, their link with both industries, especially pharmaceuticals, is still considerable" JAMA defines the significance of their article: "The medical profession has embraced the importance of placing patient welfare ahead of financial benefits to physicians in clinical decision making. One tenet of medical professionalism is managing conflicts of interest related to physician-industry relationships".

See the full article @ "Medical News Today"

Friday, November 5, 2010

Hepatitis C Trial:The Doctor and The Hedge Fund Manager

Bad Medicine: When Doctors Tip Off Wall Street

Today the (TheStreet) asked this question -- "How do a French doctor and a Connecticut hedge fund manager strike up a friendship that leads to the doctor being charged with passing along inside information about a hepatitis C drug trial?"

Adam Feuerstein writes;

"This is likely how two men of disparate backgrounds -- Benhamou, a doctor and widely published medical researcher who treated hepatitis C patients from an affluent suburb of Paris, and the hedge fund manager who lived and worked in Connecticut but who is not identified in court papers, got to know each other".

Continue Reading..........

Wednesday, November 3, 2010

AASLD:Making News Hepatitis C Drug:TMC435

Painting By G. Harvey
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I wanted to make mention today about an on going entry here on the blog. *found on the sidebar. " Hepatitis C Drugs and Wall Street " Is updated as investors publish new articles of interest on their websites.
*keep in mind that this is only another resource for news, and looking at the data coming from the AASLD is reliable and much more comprehensive.
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In Case You Missed It:
At the end of October over at shearlingsplowed the blogger gave a nod to Adam Feurstein, who reports for TheStreet.com. The link to Mr. Feursteins original article was added to HCV Drugs/WS .
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He writes; Adam Feurstein, writing for TheStreet.com, has done a nice job of summarizing the next-gen Hep C "state of the play" -- as to the most important candidates in Boston, at the big liver conference "Because there will still be some patients who won't respond to Telaprevir®, or Boceprevir®, J&J (via a The Medicines Company-researched drug candidate, thus the TMC nomenclature) is advancing a powerful alternate candidate, still about four years away from market, to follow in Telaprevir's wake:

. . . .In addition to partnering with Vertex on Telaprevir, Johnson & Johnson is developing its own Hep C drugs, including TMC435. A phase IIb study being presented Monday shows that between 79% and 86% of patients treated with TMC435 and standard of care responded well enough to stop all therapy after 24 weeks. This interim result for TMC435 looks better than the 58% and 65% of telaprevir-treated patients who were able to stop therapy after 24 weeks, except that J&J used a more liberal definition of response, which inflates its numbers. Patient treated with higher doses of TMC435 also reported increases in certain liver enzymes levels, raising safety concerns about the drug. . . .So, the Vertex juggernaut in Hep C may only last for about five years -- but that will certainly be "enough" -- enough to clearly label Ex-Schering-Plough CEO Fred Hassan's Boceprevir as primarily a second-line "me too" candidate. We'll keep you informed.

From Medpage :
AASLD: TMC435 Rapid Response for Once-Daily Protease Inhibitor

excerpts:
"In an interim analysis of a phase IIb, five-arm trial, genotype 1 hepatitis C patients taking various doses of TMC435 in addition to peginterferon and ribavirin had significantly greater responses at four weeks than those on combination therapy plus placebo (68% to 79% versus 5%), according to Michael Fried, MD, of the University of North Carolina Chapel Hill, and colleagues"

"There were no differences in adverse events, including rash, anemia, or gastrointestinal events, and the most common effects were headache and fatigue, which were comparable across all groups. Discontinuation rates were similar across all groups as well.There were, however, "small and transient" elevations in bilirubin levels for patients in the 150-mg dose groups, which Fried said resolved after treatment ended."We see some increase in bilirubin, but it's completely reversible," he said, adding the effects are "clearly related to a transporter mechanism as opposed to hepatotoxicity."He added that despite these effects, "in my opinion, the 150-mg dose is probably the way to go." Full Data

AASLD:TMC435 PILLAR study in treatment-naive patients/ genotype 1

The results showed that in the four TMC435 treatment groups between 79 and 86 percent of patients were able to stop all therapy at Week-24, according to the response criteria defined in the study protocol. There were no relevant differences for adverse events between TMC435 treatment groups and placebo. TMC435, a hepatitis C protease inhibitor, dosed once daily (q.d.) is being developed jointly by Tibotec Pharmaceuticals and Medivir.
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Todays AASLD Updates:

AASLD:SVR for hepatitis C boon to patients 20 yrs down the road

Check Back For Links and Updates @ Hepatitis C Drugs and Wall Street

Tuesday, November 2, 2010

Hepatitis C: Drug Companies and Doctors get greedy;The Hedge Fund


A French doctor who worked as a consultant for Human Genome Sciences Inc. has been charged by the U.S. with insider-trading for allegedly tipping off a hedge fund about negative results of Albuferon drug trials.
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Dr. Yves Benhamou, 50, of France, was arrested today on two federal charges filed by prosecutors in the office of Manhattan U.S. Attorney Preet Bharara, the FBI in New York said. Human Genome Sciences, or HGSI, is a developer of gene-based drugs.

Yesterday in the news :Roche Two Fines/One For Pegasys:Monies Paid To Nurse/Health Service To Use Drug

On Oct 26 ; HCV: A New Drug Enterprise For The Convicted Sam Waksal ?


Sunday, October 31, 2010

Telaprevir Over Boceprevir?

Related Updates; May 2011
FDA OKs Telaprevir for Hep C; Financial Assistance/Prescribing Information
Vicrelis/Boceprevir IS NOW FDA Approved May 13 2011
Getting Ready; Telaprevir or Boceprevir ?
Updated Daily;
Hepatitis C In The News 
List Of All Articles On;
Telaprevir
Boceprevir

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Today From Boston (TheStreet) -- Reported on Telaprevir at the American Association for the Study of Liver Disease (AASLD). The article is presented for investors, but has data we all can use.

Adam Feuerstein writes;" Vertex Pharmaceuticals: Telaprevir was the superior hepatitis C drug coming into AASLD and no data or information released over the weekend, including from Merck and its competing drug boceprevir, changed that view. If there's a debate left to have about telaprevir vs. boceprevir in hepatitis C, it's forecasting the market share each drug may garner once both are approved next year".

The investors are waiting for physicians/researchers to see all the data from the phase III studies which will be presented on Monday and Tuesday at the AASLD.

Mr. Feuerstein also remarked on Mercks/boceprevir press released on Saturday. AASLD:Hepatitis C Boceprevir Achieved Significantly Higher Sustained Virologic Response Rates Compared to Control

He wrote they had a lot of statistics but the overall profile of boceprevir was not quite as good as telaprevir. He is waiting for Monday/Tuesday for updates on why the analysis summarized appears to exclude certain patients. He writes " Boceprevir's overall cure rate for treatment-naive Hep C patients ranged from 63-66%, with the proportion of patients eligible for shortened therapy 44%. The cure rate was high (87% for African-American/Blacks and 97% for non-African Americans) for those patients that did receive shortened therapy due to an early and robust response to boceprevir. When these "treatment resistant" patients were re-treated with boceprevir, cure rates ranged from 59% to 66% compared to 21% of patients re-treated with just standard of care.
Vertex has data on telaprevir in similar hard-to-treat patients that is superior to boceprevir, with
cure rates of 65% overall that included patients much more resistant to therapy than those enrolled in Merck's boceprevir study. When similar treatment-resistant patients are compared across both studies, boceprevir's 66% cure rate falls short of telaprevir's 78% cure rate. Vertex is not presenting its telaprevir data in treatment resistant patients at this year's AASLD meeting.

The article also covers Gilead Sciences, and Dr. John McHutchison who has joined the company. Dr. McHutchison gave investors a detailed look at the Hepatitis C drug development efforts. Other drugs were touched on such as RG7128 , IDX184 and TMC435. You may want to go take a look at his article.

http://www.thestreet.com/story/10905966/1/hep-c-update-vertex-merck-and-gilead.html?puc=_tscrss

Friday, October 29, 2010

Merck,Johnson&Johnson/Bristol-Myers Race For Hep C Drug/video

Drugs Companies Seek Cocktail For Hepatitis C


Bristol-Myers, Gilead Seek AIDS Cocktail to Match Success in Hepatitis C
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Today bloomberg published an article on the aspirations of Bristol-Myers and Gilead ; the two drug companies are hoping to find the same success with HCV they have with their top selling oral combination for AIDS.
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Quoted from the article:"The new antiviral combinations are oral drugs, not injections, and may have the potential to cure patients who haven’t benefitted from the older products, Liang said. “Both clinicians and patients would prefer drugs that lack the side effects of interferon and ribavirin,” said Alexandra Makarova, an analyst at Decision Resources, a research company in Burlington, Massachusetts, in a telephone interview. “If the combination of direct antivirals will allow doctors to exclude interferon and ribavirin, it could spoil the party for those regimens.” Optimal Combination Research hasn’t identified the optimal oral combination for hepatitis C. Initial reports show treatment with just one pill or low-dose combinations aren’t enough to keep the virus in check, and investigators are building more, and more-powerful, combinations. The U.S. Food and Drug Administration, which initially rejected efforts to study treatments without interferon and ribavirin, has now let trials begin".
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.Telaprevir /VX-222 .
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As for the latest news on Vertex's Telaprevir/VX-222 combination, Michelle Fay Cortez writes: "Adding ribavirin alone delayed or reduced the breakthrough virus, the study found. Vertex stopped a low-dose combination of telaprevir and its experimental drug VX-222 after the virus broke through during the first month of treatment. A higher-dose combination is undergoing tests".
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(excerpt)

Oct 25, 2010 "Vertex today announced the initiation of a Phase 3b clinical trial to evaluate twice-daily dosing of telaprevir (1,125 mg; BID) compared to three-times-daily dosing of telaprevir (750 mg; q8h) in combination with pegylated-interferon and ribavirin for people with genotype 1 hepatitis C. Patient screening for enrollment in the study is expected to start in November 2010.
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Additional details on this trial were provided today in a separate press release. Ongoing Phase 2 Trial Evaluating Combination Regimens of VX-222 and Telaprevir Vertex announced today that it has modified its clinical trial evaluating telaprevir dosed in combination with Vertex's lead HCV polymerase inhibitor, VX-222. The company will discontinue Arm A of this study as a result of patients meeting a pre-defined stopping rule related to viral breakthrough during the first four weeks of dosing. Arm A was designed to evaluate a two-drug regimen of VX-222 (low dose; 100 mg) and telaprevir (1,125 mg) both dosed twice daily without pegylated-interferon and ribavirin. The additional three arms of the study are continuing without modification, and no viral breakthrough has been reported in these arms. This Phase 2 proof-of-concept trial began dosing patients in August 2010 and is designed to evaluate safety and SVR rates using 12-week response-guided regimens of telaprevir/VX-222-based combination therapy in people with genotype 1 hepatitis C. The trial is continuing to evaluate treatment regimens that include four-drug regimens of telaprevir, VX-222, pegylated-interferon and ribavirin, as well as a two-drug regimen of only telaprevir (1,125 mg) and a higher dose of VX-222 (400 mg), both dosed twice daily. Trial sites have now completed patient recruitment, which Vertex expects will enable it to reach the initial target enrollment of 100 patients for the study. Vertex expects to obtain on-treatment clinical data from this trial in the first half of 2011 and SVR data in the second half of 2011" Read In Full.....
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.Also mentioned in the article from bloomberg were BMS-790052 and BMS-650032, protease inhibitor, GS-9256, with a second new drug, GS-9190.
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Tuesday, October 26, 2010

Infectious Disease:Antiviral Therapies The Money Makers


The Wall Street Journal hinted today why drug companies like Bristol-Myers and Johnson & Johnson are in the infectious disease business. (Note Vertex began the clinical development of Telaprevir in 2004 and is collaborating with Johnson & Johnson and Mitsubishi Tanabe Pharma) According to Jonathan D. Rockoff from the WSJ, patients in the U.S. can't afford the high cost of prescriptions and the European governments with their own financial obstacles are working to control price increases. The drug business is taking a hit because of the economy. The business of antiviral agents are giving these drug companies a shot at some real cash flow. The buzz is J&J may expand in infectious disease, as for Bristol-Myers they came out with their own sad earnings today. (See more on Bristol-Myers at Wall Street Journal )
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Bristol’s is developing BMS-790052 NS5A Inhibitor plus BMS-650032 Protease Inhibitor for treating HCV. The company is recruiting patients in their phase II trial "Study to Determine the Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Who Have Previously Failed Standard of Care" (see trial status ) and locations below.
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Additional information on the blog: (BMS-790052) With Peginterferon/Ribavirin Trials
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Note:
New data on multiple Bristol-Myers Squibb Company compounds will be presented at the 61st annual meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston from beginning this Friday : October 29 to November 2.

Read complete article here...


Contacts
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:
mailto:Clinical.Trials%40bms.com?subject=NCT01012895,
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Locations
United States, California
Advanced Clinical Res Inst
Recruiting
Anaheim, California, United States, 92801
Contact: Michael Demicco, Site 004 714-774-7777
San Jose Gastroenterology
Recruiting
San Jose, California, United States, 95128
Contact: Huy Ngoc Trinh, Site 018
United States, Colorado
University Of Colorado Denver & Hospital
Recruiting
Aurora, Colorado, United States, 80045
Contact: Gregory Everson, Site 007 303-724-1877
United States, Maryland
Mercy Medical Center
Recruiting
Baltimore, Maryland, United States, 21202
Contact: Paul Thuluvath, Site 014 410-576-5389
United States, Massachusetts
Llc Dba The Research Institute
Recruiting
Springfield, Massachusetts, United States, 01107
Contact: Claudia T. Martorell, Site 002 413-747-5566
United States, Michigan
University Of Michigan Health System
Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Anna S. F. Lok, Site 009
United States, North Carolina
Charlotte Gastroenterology & Hepatology, Pllc
Recruiting
Charlotte, North Carolina, United States, 28207
Contact: John S. Hanson, Site 016 704-375-9485
Carolinas Center For Liver Disease
Recruiting
Statesville, North Carolina, United States, 28677
Contact: Robert W. Reindollar, Site 013 704-978-1144
United States, Texas
Reem H. Ghalib, Md
Recruiting
Arlington, Texas, United States, 76012
Contact: Reem H Ghalib, Site 012 817-471-1070
Alamo Medical Research
Recruiting
San Antonio, Texas, United States, 78215
Contact: Eric J. Lawitz, Site 003 210-253-3426
United States, Virginia
Metropolitan Research
Recruiting
Fairfax, Virginia, United States, 22031
Contact: Vinod K. Rustgi, Site 010 703-698-9254

Nov 2010 Telaprevir® Vertex Competes FDA Application; Asking for “Fast Track”

Update; Jan 20, 2011 -Vertex Pharma's Hep C drug gets priority review
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"Administration for a priority review of data from telaprevir in November, said the agency set an action date for May 23 to decide on the approval."
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Thu Jan 20, 2011 8:08am EST* Drug gets priority review status from FDA, Health Canada*
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FDA sets action date for May 23
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Jan 20 (Reuters) - Vertex Pharmaceuticals Inc (VRTX.O) said its experimental treatment for Hepatitis C got priority review status from health regulators in the United States and Canada.Cambridge, Massachusetts-based Vertex, which had asked the U.S. Food and Drug Administration for a priority review of data from telaprevir in November, said the agency set an action date for May 23 to decide on the approval.Priority review status from the FDA reduces the review period by four month, the company said. The same status from Canadian health regulator Health Canada cuts short the review period to six to nine months, compared to a review period of 18 months or more.Vertex is developing telaprevir in collaboration with Tibotec Pharmaceuticals, a unit of Johnson & Johnson (JNJ.N), and Mitsubishi Tanabe Pharma (4508.T).Vertex holds rights to market the drug in North America while Tibotec has rights to market it in Europe, South America, Australia, the Middle East and certain other countries. Mitsubishi Tanabe has rights in Japan and certain Far East countries.Shares of Vertex have risen 15 percent since it applied for the priority review. They closed at $39.45 Wednesday on Nasdaq. (Reporting by Vidya L Nathan in Bangalore
UPDATE NOVEMBER 23 2010

Vertex Completes New Drug Application for Telaprevir for Hepatitis C
Vertex Files Telaprevir® With FDA; Asking for “Fast Track” — Likely To Get It
“We are committed to working closely with the FDA to make telaprevir available as quickly as possible to the millions of people with hepatitis C who need new medicines to increase their chances for a viral cure.”

Nov 23 2010

This drug will bring hope to the population of our friends, family and over four million chronic carriers of hepatitis C in the U.S. Giving hope to some of those people who once had none. It is happening folks, the progression of liver disease and damage stops here. Think what this means; the chance for SVR after or before liver transplantation. A chance for people who currently have liver damage and for the difficult to treat genotype 1. These people will finally have a chance to achieve a cure.
In the future this could mean..NO liver transplants, no pain, a cure ! As for people that have not previously treated HCV they can begin treatment without the fear of failing. These people are no longer looking at a fifty percent chance to eradicate the virus. The stats are on your side, for the first time in ten years.
I am so excited, so overwhelmed..........its a ground breaking day.

FAST TRACKED........ is the word of the day. Hope is the future

- Submission based on results from Phase 3 studies that showed high SVR (viral cure) rates with telaprevir-based combination therapy compared to approved medicines -

- Six-Month Priority Review Requested -

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that it has completed the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for telaprevir, Vertex’s investigational treatment for people with hepatitis C. The NDA submission is supported by results from three Phase 3 studies, ADVANCE, ILLUMINATE and REALIZE, which evaluated telaprevir in people chronically infected with genotype 1 hepatitis C virus (HCV) who were new to treatment as well as those who were treated before but did not achieve a sustained viral response (SVR, or viral cure).

The submission includes a request for Priority Review, which would reduce the FDA’s review time from 10 months to six months. The FDA grants Priority Review status for several reasons, including if the medicine is considered a major advance in treatment.

“This submission is a milestone in our more than 15-year effort to change the way hepatitis C is treated,” said Matthew Emmens, Chairman, President and Chief Executive Officer of Vertex. “We are committed to working closely with the FDA to make telaprevir available as quickly as possible to the millions of people with hepatitis C who need new medicines to increase their chances for a viral cure.”


Highlights of the Telaprevir Phase 3 Data Included in the Submission

All Phase 3 studies met their primary endpoints and results below are from the treatment arms where telaprevir was started immediately in combination with pegylated-interferon and ribavirin for the first 12 weeks of treatment.

In people with hepatitis C who were new to treatment (treatment-naïve):

• Up to 75% achieved a viral cure with telaprevir-based combination therapy, compared to 44% of people who received pegylated-interferon and ribavirin alone;

• A majority (58% in ADVANCE and 65% in ILLUMINATE) were eligible to reduce their treatment time by half – from 48 weeks to 24 weeks; and

• Data showed there was no benefit to extending total treatment from 24 weeks to 48 weeks in people whose virus was undetectable at weeks 4 and 12 with telaprevir-based therapy.

In the three major subgroups of people with hepatitis C who had not achieved a viral cure with a prior course of treatment (treatment-experienced):

• 83% of prior relapsers, 59% of prior partial responders and 29% of prior null responders achieved a viral cure with telaprevir-based combination therapy compared to 24%, 15%, and 5% of people in these subgroups, respectively, who received pegylated-interferon and ribavirin alone. These results were achieved with a simultaneous start of all three drugs for the first 12 weeks followed by pegylated-interferon and ribavirin alone for an additional 36 weeks.

The safety and tolerability results of telaprevir-based combination therapy were consistent across the Phase 3 studies. The most common adverse events regardless of treatment arm were rash, fatigue, pruritis, headache, nausea, anemia, insomnia, diarrhea, flu-like symptoms and pyrexia, with the majority being mild or moderate in severity.

More Effective Therapies Needed to Improve Viral Cure Rates

Hepatitis C is a serious disease, typically without symptoms, which affects up to 3.9 million people in the United States. Hepatitis C can lead to scarring of the liver (cirrhosis), resulting in liver failure, liver cancer and the need for liver transplantation. Approved medicines for people with genotype 1 hepatitis C are given for a year, and less than half of people treated with these therapies achieve a viral cure.4,5,6 Telaprevir is an investigational, oral inhibitor that acts directly on the HCV protease, an enzyme essential for viral replication. To date, more than 2,500 people with genotype 1 hepatitis C have received telaprevir in Phase 2 and Phase 3 studies.

“In our trials, starting patients with 12 weeks of telaprevir-based combination therapy significantly improved viral cure rates compared to treatment with currently approved medicines, even in groups of people considered the most difficult to treat,” said Peter Mueller, Ph.D., Chief Scientific Officer and Executive Vice President of Global Research and Development at Vertex. “We’re also encouraged by telaprevir data that showed most patients new to therapy were able to achieve high viral cure rates and reduce their total treatment time by half.”

Vertex is developing telaprevir in collaboration with Tibotec Pharmaceuticals and Mitsubishi Tanabe Pharma. Vertex has rights to commercialize telaprevir in North America and Tibotec has rights in Europe, South America, Australia, the Middle East and certain other countries. Mitsubishi Tanabe Pharma has rights to commercialize telaprevir in Japan and certain Far East countries.

Vertex was granted Fast Track designation by the FDA for telaprevir in 2005. In mid-2010, as part of the Fast Track designation, Vertex began to submit completed sections of the NDA for review by the FDA on a rolling basis rather than wait until every section of the application was complete.

Data from Phase 3 Studies in All Major Patient Types, Including the Most Difficult-to-Treat

The Phase 3 studies evaluated people with genotype 1 hepatitis C who were new to treatment as well as those who had previously received treatment but did not achieve a cure, including people who have traditionally responded poorly to approved medicines. In Phase 3 studies, telaprevir was given to people three times a day in combination with pegylated-interferon and ribavirin for the first 12 weeks of therapy followed by either 12 weeks or 36 weeks of Pegasys® (pegylated-interferon alfa-2a) and Copegus® (ribavirin) alone for a total treatment time of either 24 weeks or 48 weeks. The ability to shorten treatment time from 48 weeks to 24 weeks for people new to treatment was based on their response to therapy at weeks 4 and 12. People who did not achieve a viral cure with a prior course of therapy received a total of 48 weeks of treatment. In October 2010, Vertex announced the start of a Phase 3 study to evaluate twice-daily (BID) dosing of a telaprevir-based combination regimen.

ADVANCE: Pivotal study in 1,095 people who were new to treatment

The primary endpoint of ADVANCE was SVR, defined as the proportion of people who had undetectable viral load (HCV RNA) both at the end of treatment and 24 weeks after the end of treatment. The secondary endpoint was to evaluate the safety of telaprevir when dosed in combination with pegylated-interferon and ribavirin. ADVANCE also evaluated the ability to reduce total treatment time by half – from 48 weeks to 24 weeks, which was guided by a patient’s response to therapy (undetectable viral load at weeks 4 and 12).

ILLUMINATE: Supplemental study in 540 people to evaluate shorter treatment durations in people who were new to treatment

The primary endpoint of the study was SVR in two telaprevir-based treatment arms of people whose virus was undetectable at week 4 and week 12 of treatment (eRVR, extended rapid viral response). These patients were randomized to either 24 weeks or 48 weeks of total therapy. ILLUMINATE was designed to evaluate whether there was any benefit to extending therapy from 24 weeks to 48 weeks in people who met these criteria. There was no control arm of pegylated-interferon and ribavirin alone in the study.

In both the ADVANCE and ILLUMINATE studies, telaprevir-based combination therapy also resulted in improved SVR rates in various subgroups of people with characteristics known to limit response to approved medicines such as race/ethnicity or stage of liver fibrosis. Data from these studies were presented in November 2010 at the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD).

REALIZE: Pivotal study in 662 people who did not achieve a viral cure with previous therapy

The primary endpoint of the study was SVR in each of the two telaprevir treatment arms compared to the control arm, and for the three subgroups of people included in the study. REALIZE is the only Phase 3 study to date of a direct-acting antiviral medicine to include all three major subgroups of people with hepatitis C who did not achieve a viral cure with a previous course of therapy:

• Relapser: defined as a person whose hepatitis C virus was undetectable at the completion of at least 42 weeks of a prior course of therapy but whose virus became detectable during the follow-up period;

• Partial Responder: defined as a person who achieved at least a 2 log10 (100 times) reduction in viral load (HCV RNA) at week 12, but whose hepatitis C virus never became undetectable by week 24 of a prior course of therapy; and

• Null Responder: defined as a person who experienced a less than 2 log10 drop in viral load at week 12 of a prior course of therapy.

In REALIZE, people received 48 weeks of total therapy, which included 12 weeks of telaprevir combined with pegylated-interferon and ribavirin. One of the telaprevir treatment arms was designed to evaluate, for the first time, whether viral cure rates could be further improved by starting pegylated-interferon and ribavirin alone for the first four weeks of treatment (delayed start) compared to a simultaneous start of telaprevir in combination with these medicines. There was no clinical benefit observed with the telaprevir delayed-start treatment arm in any of the subgroups of patients compared to the simultaneous-start arm. Final results from REALIZE, including safety and efficacy data, will be presented at an upcoming medical meeting.

Safety and Tolerability Information for ADVANCE, ILLUMINATE and REALIZE

The safety and tolerability results of telaprevir-based combination regimens were consistent across the Phase 3 studies. The most common adverse events (AEs) were rash, fatigue, pruritis, headache, nausea, anemia, insomnia, diarrhea, flu-like symptoms and pyrexia with the majority being mild or moderate in severity. Rash and anemia occurred more frequently in the telaprevir treatment arms compared to the control arms.

Rash was primarily characterized as eczema-like, manageable and resolved upon stopping telaprevir. More than 90% of rash was mild to moderate and was primarily managed with the use of topical corticosteroids and antihistamines. Anemia was primarily managed by reducing the dose of ribavirin. Erythropoiesis-stimulating agents (ESAs) were used in only 1% of people in the Phase 2 and Phase 3 studies. Discontinuation of all drugs due to either rash or anemia during the telaprevir/placebo treatment phase was 1% to 3% in the telaprevir treatment arms.

About Hepatitis C

Hepatitis C is a serious liver disease caused by the hepatitis C virus, which is spread through direct contact with the blood of infected people and ultimately affects the liver.2 Up to 3.9 million people in the United States have chronic hepatitis C and 75% of those infected are unaware of their infection.3 The majority of people with hepatitis C were born between 1946 and 1964, accounting for two of every three people with chronic hepatitis C.11 Chronic hepatitis C can lead to serious and life-threatening liver problems, including liver damage, cirrhosis, liver failure or liver cancer.2 Though many people with hepatitis C may not experience symptoms, others may have symptoms such as fatigue, fever, jaundice and abdominal pain.2

Approximately 60 percent of genotype 1 patients who undergo an initial 48-week regimen with pegylated-interferon and ribavirin, the currently approved medicines, do not achieve SVR, 4,5,6 or viral cure.1 If treatment is not successful and a person does not achieve a viral cure, they remain at an increased risk for progressive liver disease.7,8,9,10,11 In the United States, hepatitis C is the leading cause of liver transplantations and is reported to contribute to 4,600 to 12,000 deaths annually.8 By 2029, total annual medical costs in the U.S. for people with hepatitis C are expected to more than double, from $30 billion in 2009 to approximately $85 billion.11

Additional resources for media are available at: http://investors.vrtx.com/press.cfm .

* Expects to seek telaprevir approval in coming weeks
NEW YORK Oct 25 (Reuters) - Vertex Pharmaceuticals on Monday reported a wider third-quarter loss as it stepped up research on its promising experimental treatment for hepatitis C, and said it plans to seek U.S. approval for the medicine in coming weeks.

Vertex (VRTX.O) said it had a net loss $209 million, or $1.04 per share, in the third quarter, as it spent heavily on mid-stage and late-stage trials of its telaprevir treatment for the liver disease. That compared with a net loss of $149.6 million, or 84 cents per share, a year ago.

Analysts on average expected a loss of 93 cents per share in the most recent quarter, according to Thomson Reuters I/B/E/S.

Vertex reported third quarter revenue of $23.8 million. Wall Street was expecting revenue of $30.3 million.

The Cambridge, Massachusetts-based company, which is also developing treatments for inflammation, cystic fibrosis, and other diseases, said it continues to expect a net loss of $750 million for full-year 2010. Excluding special items, it expects a loss of $600 million.

Telaprevir is widely expected to become a game changer in the treatment of hepatitis C, which can severely damage the liver over a period of decades after infection with the virus. Some analysts believe the drug could eventually garner annual sales of more than $4 billion.

The lofty expectations are based on telaprevir's ability to cure a far higher percentage of patients than the tough to tolerate standard drugs, and its potential to cut the current 48-week treatment duration in half when used in combination with interferon and ribavirin.

In September, Vertex said telaprevir in a pivotal late-stage trial cured 65 percent of patients who had previously failed to be cured by standard drugs.

Telaprevir, from a new class of hepatitis C treatments, is an antiviral drug that is expected to compete with a similar medicine being developed by Merck & Co (MRK.N) called boceprevir. But analysts have been virtually unanimous in their belief that telaprevir is the superior medicine.

Merck has completed phase III trials. (Reporting by Ransdell Pierson; Editing by Carol Bishopric)

HCV: A New Drug Enterprise For The Convicted Sam Waksal ?


Sam Waksal, is the former CEO of ImClone Systems, whose insider trading lead to spending time in prison along with Martha Stewart, remember? Announced today; "Waksal said his drug company Kadmon Pharmaceuticals has bought the privately held Three Rivers Pharmaceuticals, and that its treatments for hepatitis C, infections and cancer will be the backbone of his new enterprise".
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Why am I so agitated? It holds little merit knowing the real importance is in developing drugs to treat cancer and HCV. Still, I remain annoyed this man may profit in his venture after being deemed once as deceitful . Just putting it out there folks.
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Mon Oct 25, 2010 2:16pm EDT
By Ransdell Pierson

NEW YORK, Oct 25 (Reuters) - Sam Waksal, the former chief executive of ImClone Systems Inc, whose insider trading scam sent him and Martha Stewart to prison, on Monday announced an acquisition meant to catapult him back into the biotech game.
Waksal said his drug company Kadmon Pharmaceuticals has bought the privately held Three Rivers Pharmaceuticals, and that its treatments for hepatitis C, infections and cancer will be the backbone of his new enterprise.
"Hepatitis treatment is on the verge of major change," Waksal said in a release. "With Three Rivers as a cornerstone, Kadmon will play an important role in the evolution of this global market."
Kadmon did not provide financial details, although the Wall Street Journal valued the deal at more than $100 million. Waksal said Kadmon will keep Three Rivers' headquarters in Warrendale, Pennsylvania, and its manufacturing, distribution, commercial and administrative operations.
Waksal was convicted in 2002 of securities fraud, bank fraud, obstruction of justice and perjury. After paying $4.3 million in fines and serving five years in prison, he was released in February 2009.
The U.S. Securities and Exchange Commission barred Waksal from serving as a director or officer of any public company.
Three Rivers sells hepatitis C drugs, including the Infergen brand of interferon and its Ribasphere and RibaPak brands of the anti-viral drug ribavirin. But the products have tiny sales compared to leading interferons and ribavirins sold by drugmakers Merck & Co (MRK.N) and Roche Holding AG (ROG.VX) for liver disease.
Three Rivers also sells Amphotec for treatment of invasive aspergillosis, a dangerous systemic fungal infection, and a generic form of AstraZeneca Plc's (AZN.L) breast cancer treatment Arimidex (anastrozole). And it is developing new cancer medicines.
Neither Waksal nor Three Rivers could be immediately reached for comment.
Kadmon, whose lead investor is SBI Holdings Inc of Japan, said the Three Rivers purchase was financed through debt and equity capital.
Waksal, an immunologist, founded New York-based ImClone in 1984 and spearheaded development of its Erbitux drug for colon cancer. But when the U.S. Food and Drug Administration initially rejected the drug, Waksal tipped off relatives and friends to sell their ImClone shares before the rejection was made public.
Regulators became suspicious when his father and daughter sold $9.2 million of ImClone shares, and eventually arrested Waksal for attempting to dump his own shares and tipping off the others.
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Updated Nov 2
Waksal inks pair of hepatitis C pacts for his start-up
November 2, 2010 — 9:46am ET By John Carroll
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Sam Waksal (photo) got a chance to flex his long neglected deal-making muscles with a pair of pacts with Valeant Pharmaceuticals ($VRX) that will help the ex-con build up a hepatitis C franchise as Valeant exits the R&D side of that business.
Waksal's start-up, Kadmon, gained most of the world rights to develop and commercialize taribavirin in exchange for $5 million upfront, unspecified milestones and a royalty stream that will scale between 8 percent and 12 percent. And Valeant gained some European commercial rights to all dosages of ribavirin for $7.5 million. That drug will now be marketed in Valeant's package of branded generics.

Valeant Chief Executive Michael Pearson has been moving out of development activities for hepatitis C as the company, created from the merger of Biovail and Valeant, restructures its R&D side to focus on CNS and dermatology.

"Kadmon is building upon its commercial platform in hepatitis C through expanded global distribution and the addition of complementary products," said Waksal, who spent five years in prison for his role in a notorious insider trading scandal. "Our agreements with Valeant achieve milestones for both of these objectives. Taribavirin completes our ribavirin franchise and will ensure its future sustainability and growth. We have also expanded our global distribution network for ribavirin into markets in which Valeant is a leading provider.
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Tuesday, October 19, 2010

Drug Companies Hire Troubled Doctors As Experts

From NPR
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Drug Companies Hire Troubled Doctors As Experts
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Pfizer, one of the largest drug makers in the U.S., saw $27.8 billion in sales in 2009. Seven drug companies, including Pfizer, have disclosed information about doctors who receive payment for speaking fees related to products they sell.
Audio/Full Story,



,Wall Street Journal

In the Wall Street journal today; it was reported Johnson & Johnson is planning on expanding its work with infectious diseases like HIV, and hepatitis C. Telaprevir is being developed with partner Vertex Pharmaceuticals.









Monday, October 11, 2010

2010 Hepatitis C Drugs and Wall Street/Part One

Wall Street U S A Painting by George Mamos
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, ,.2010: Archives Hepatitis C Drugs and Wall Street
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Week Of Dec 20th
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This analysis comes from analysts at S.G. Cowen, who in a note to investors make a bunch of actionable predictions for the new year. Among them: that the sarcoma drug Ariad Pharmaceuticals is developing with Merck might succeed, and that there is a low – but higher than investors think – chance that Vertex Pharmaceuticals’ telaprevir, for hepatitis C, could be rejected by the Food and Drug Administration because of its side effects. But one of the most mind-bending is the low probability prediction that one of the five companies expected to launch a drug next year will actually manage to deliver good stock performance.
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Pharmaceutical Executive
The providential similarities between HIV and the Hepatitis C virus (HCV) have enabled researchers at the level of viral dynamics to apply their crisis-driven know-how about designing drugs to target specific proteins and enzymes on the first retrovirus to that of the second.
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Vertex Pharmaceuticals Inc. discontinued one part of a clinical study evaluating its hepatitis C treatments.Vertex is halting a test of its medicine telaprevir in combination with its other experimental therapy called VX-222, the Cambridge, Massachusetts-based company said in a statement.
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Here we go again folks with more fraudulent behavior from four of the biggest pharmaceutical companies, they are; GlaxoSmithKline, Pfizer, Eli Lilly and Schering -Plough. The report can be found @ Pharma Times .Quoted From The Article:"The drug industry has now become the biggest defrauder of the US government, surpassing defence, the long-time leader.That is the claim of a study from the influential US consumer group Public Citizen, which found that pharmaceutical cases accounted for at least 25% of all federal False Claims Act payouts over the past decade, compared with 11% by the defence industry. The analysis looked at all major pharmaceutical company civil and criminal settlements on state and federal levels since 1991".
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About Vertex Pharmaceuticals Incorporated (Public, NASDAQ:VRTX)
Vertex Pharmaceuticals Incorporated (Vertex) is engaged in the business of discovering, developing and commercializing small molecule drugs for the treatment of serious diseases. Telaprevir, the Company’s lead drug candidate, is an oral hepatitis C protease inhibitor and a new class of antiviral treatments in clinical development that target hepatitis C virus (HCV), infection. Telaprevir is being evaluated in a registration program focused on treatment-naïve and treatment-failure patients with genotype 1 HCV infection. VX-770, the lead drug candidate in its cystic fibrosis (CF), program is being evaluated in a registration program that focuses on patients with CF who have the G551D mutation in the gene responsible for CF. Vertex is conducting a number of Phase IIa clinical trials of its earlier-stage drug candidates. On March 12, 2009, Vertex acquired ViroChem Pharma Inc. (ViroChem).
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Switzerland’s La Roche AG has demanded a Vietnamese firm to stop making Pegnano on allegations the hepatitis drug uses a compound patented in Vietnam. Roche has sent a letter to Ho Chi Minh City-based Nanogen Biopharmaceutical Ltd Company, requesting the latter to stop producing, circulating and advertising its Pegnano from December 30. Pegnano is sourced from Peginterferon alfa 2a that the Swiss firm says is patented in Vietnam......
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Week Of Dec 13th
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Morningstar Makes Vertex Its No. 1 BioTech Play -- Due To Telaprevir's Chances
Chicago-based Morningstar, those investment mavens with a truly independent analyst function (Morningstar has no affiliate that handles securities underwritings, or M&A advisory roles -- decidedly unlike JP Morgan and Morgan Stanley) just made Telaprevir®'s very likely win over legacy Schering-Plough/New Merck's Boceprevir® the basis for its "Top of the Heap" prediciton, this morning.See it all here
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SciClone Pharmaceuticals, Inc. (SCLN) lost 9.77 percent to $3.60 in the after-hours trading. The company said its phase 2b study of SCV-07 for treating hepatitis C patients failed to meet its primary endpoint, prompting to abandon further trials. The primary efficacy endpoint pertained to 2 log reduction in viral load from baseline level.
However, SciClone hopes to tap its potential in the prevention of oral mucositis in patients with head and neck cancer, for which SciClone expects to commence a phase 2b study by early 2011
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A Second Wind for InterMune
By Brett Chase Dec 17, 2010 1:30 pm
InterMune (ITMN) has new life. After a devastating setback when US officials rejected the company’s lung disease drug in May, InterMune moved a step closer to selling the treatment in Europe
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Published Amarillo Biosciences completes patient enrolment in phase II hepatitis C trialFriday, December 17, 2010 16:45 IST Amarillo, TexasAmarillo Biosciences, Inc. announced that enrolment in a phase II clinical trial of 165 patients with chronic hepatitis C virus infection is now complete. The clinical trial is being conducted in Taiwan and funded by ABI’s strategic partner, CytoPharm, Inc. The aim of the study is to reduce the virologic relapse rate for those patients who have successfully completed standard combination therapy for hepatitis C, which consists of injectable interferon alpha and Ribavirin.
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on 17/12/10 at 10:38am
A new treatment from Janssen which could help cure many more patients with hepatitis C has been submitted in Europe.
Telaprevir is an oral, direct-acting antiviral that treats chronic genotype 1 hepatitis C virus (HCV), the most common form of the virus. Europe's regulator the EMA will fast-track the drug's appraisal, in recognition of its potential to significantly improve treatment of the disease.
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Both Legacy Schering-Plough, And Now New Merck, Are Embroiled In Sales Rep "Overtime" Lawsuits
As we noted last summer, legacy Schering-Plough has been losing a federal version of these battles, appeal after appeal, over the last few years. . . now, it seems, it will be New Merck's turn before the mast.
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Ms. McCoy had run a variety of businesses across J&J before taking over its pharmaceuticals group last year. After a new-product drought, the company has launched some promising treatments recently, such as psoriasis therapy Stelara. And it is poised to seek approval for potential blockbusters to treat Hepatitis C and prevent blood clots.
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Medivir Promoted to NASDAQ OMX Stockholm Mid Cap List
HUDDINGE, Sweden--(BUSINESS WIRE)--Regulatory News:
Medivir AB (STO:MVIRB)(OMX:MVIR), the emerging research-based specialty pharmaceutical company focused on the development of high-value treatments for infectious diseases, announces that NASDAQ OMX Stockholm is promoting Medivir AB (MVIR B) from the Small Cap to the Mid Cap List. The change is effective as of January 3, 2011.
Ron Long, CEO of Medivir commented, “Medivir has had a very successful year with many important operational, as well as financial milestones achieved during the year. The Medivir share price has performed strongly during 2010 and our ambition of creating value for our shareholders will continue. The move to the Mid Cap List is an important step for the Company’s future development.”
The NASDAQ Mid Cap List is for companies with a market cap between 150 million euro and 1 billion euro.
About Medivir
Medivir is a research-based specialty pharmaceutical company focused on the development of high-value treatments for infectious diseases. Medivir has world class expertise in polymerase and protease drug targets and drug development. Medivir has a strong R&D portfolio and has recently launched its first product Xerese™/Xerclear®. Medivir’s key pipeline asset, TMC435, a protease inhibitor, is in phase 2b clinical development for Hepatitis C and is partnered with Tibotec Pharmaceuticals.
Xerese™/Xerclear® is an innovative treatment for cold sores, which has been approved in both the US and Europe. It is partnered with GSK to be sold OTC in Europe and Russia and with Meda in North America. Medivir has retained the Rx rights for Xerclear® in Sweden and Finland.
Medivir’s key pipeline asset, TMC435, a protease inhibitor, is in phase 2b clinical development for Hepatitis C and is partnered with Tibotec Pharmaceuticals.
For more information about Medivir, please visit the Company’s website: http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.medivir.se&esheet=6549375&lan=en-US&anchor=www.medivir.se&index=1&md5=f61fba926ceba48cb9a5e3b0034830d8.
This information was brought to you by Cision http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.cisionwire.com&esheet=6549375&lan=en-US&anchor=http%3A%2F%2Fwww.cisionwire.com&index=2&md5=57c470e4f93ff80b4d900f4c7578ff81
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UNIS, FTEK, ACGY, ACHN, WABC - Stocks to watch at NASDAQ
Achillion Pharmaceuticals, Inc. (Achillion) is a biopharmaceutical company focused on the discovery, development and commercialization of treatments for infectious diseases. Within the anti-infective market, the Company focuses on the development of antivirals for the treatment of chronic hepatitis C and the development of antibacterials for the treatment of resistant bacterial infections. As of December 31, 2009, Achillion focused on developing three Hepatitis C virus (HCV) drug candidates: ACH-1625, a protease inhibitor for the treatment of chronic hepatitis C in phase Ib clinical testing; ACH-1095, a NS4A antagonist also for the treatment of chronic hepatitis C, in late stage preclinical testing, and ACH-2684, a high-potency protease inhibitor in preclinical testing. In addition, it has established other product candidates, which include ACH-702 for the treatment of serious bacterial infections and elvucitabine for the treatment of human immunodeficiency virus (HIV) infection.

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News Pharmaceutical Processing
SciClone Pharmaceuticals Inc. said Wednesday that its drug candidate SCV-07 failed to meet its key goal of treating Hepatitis C in a midstage study, .
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Benhamou is a consultant to Human Genome Sciences Inc., in Rockville, Md., which is conducting trials on its Albuferon hepatitis-C drug.
Dr. Chip Skowron, a co-portfolio manager of FrontPoint's health-care funds who allegedly received the tips, has been suspended by the firm.
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Below is a look at some of the headlines for companies that made news in the healthcare sector on December 14, 2010.Amarillo Biosciences, Inc. (ABI) (OTCBB:AMAR) today announced that enrollment in a Phase 2 clinical trial of 165 patients with chronic hepatitis C virus infection is now complete.
Those of us out here in the cheap seats were under the impression hepatitis was spread through previously used needles and Desai and/or his managers ordered employees to re-use needles as a way of saving money
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Dec 9, 2010 -
(NASDAQ: VRTX)Equities research analysts at Ardour Capital initiated coverage on shares of Vertex Pharmaceuticals (NASDAQ: VRTX) in a research note to clients and investors on Friday. The analysts set an “outperform” rating on the stock.
Vertex Pharmaceuticals Incorporated (Vertex) is engaged in the business of discovering, developing and commercializing small molecule drugs for the treatment of serious diseases. Telaprevir, the Company’s lead drug candidate, is an oral hepatitis C protease inhibitor and a new class of antiviral treatments in clinical development that target hepatitis C virus (HCV), infection. Telaprevir is being evaluated in a registration program focused on treatment-naïve and treatment-failure patients with genotype 1 HCV infection. VX-770, the lead drug candidate in its cystic fibrosis (CF), program is being evaluated in a registration program that focuses on patients with CF who have the G551D mutation in the gene responsible for CF. Vertex is conducting a number of Phase IIa clinical trials of its earlier-stage drug candidates. On March 12, 2009, Vertex acquired ViroChem Pharma Inc. (ViroChem).
Shares of Vertex Pharmaceuticals (NASDAQ: VRTX) traded down 0.06% during mid-day trading on Monday, hitting $34.11. Vertex Pharmaceuticals has a 52 week low of $31.25 and a 52 week high of $44.24. The stock’s 50-day moving average is $34.90 and its 200-day moving average is $34.87. On average, analysts predict that Vertex Pharmaceuticals will post $-0.90 EPS next quarter. The company has a market cap of $6.931 billion and a price-to-earnings ratio of N/A.
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FLORENCE --Miracle drugs roll off the assembly line at Roche Carolina’s plant east of Florence by the thousands every day. The 300,000-square foot facility’s lineup of high-tech drugs includes pills that fight cancer, hepatitis, the flu and even (in the recent past, anyway) unwanted fat.
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About Idenix Pharmaceuticals, Inc. (Public, NASDAQ:IDIX)
Idenix Pharmaceuticals, Inc. (Idenix) is a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases with operations in the United States and Europe. The Company’s research and development focus is on the treatment of hepatitis C virus (HCV). In July 2009, the Company completed the proof-of-concept clinical trial in treatment-naive HCV genotype I infected patients. In October 2009, it initiated a 14-day dose-ranging phase IIa clinical trial evaluating IDX184 in combination with pegylated interferon and ribavirin in treatment-naive HCV genotype I infected patients. Idenix selected IDX320 as its lead clinical candidate from its protease inhibitor discovery program. The Company has also developed products and drug candidates for the treatment of hepatitis B virus (HBV), human immunodeficiency virus type I (HIV) and acquired immune deficiency syndrome (AIDS).
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Week Of Dec 7th
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Dec 8th
Medivir AB raised €30.8 million (US$41 million) in a private placement that brings in international institutional investors in the lead up to the start of Phase III trials of the lead product, TMC435, a protease inhibitor for treating hepatitis C (HCV) infections
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SAN DIEGO--(MARKETWIRE)
--December 8, 2010--
California Equity Research initiated coverage todayof Aethlon Medical
Director of research Bud Leedom highlighted these themes in the initiation report:Aethlon Medical is a leading player in blood filtration systems under development to treat infectious disease, cancer and in biodefense.Aethlon has begun enrollment of its Hepatitis C clinical trial in India using Hemopurifier.Hemopurifier is undergoing in vitro testing in five cancer indications focused on reducing exosome levels.Aethlon has reestablished its biodefense program and is seeking government grants.
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Provides Bi-Weekly Update on Its Status 12/8/2010
MONTREAL, QUEBEC--(Marketwire - December 08, 2010) - Ambrilia Biopharma Inc. (TSX: AMB) is providing today its bi-weekly
Default Status Report under National Policy 12-203 - Cease Trade Orders for Continuous Disclosure Defaults ("Default Status Report").
On November 10, 2010, Ambrilia announced that the filing of its interim financial statements, management's discussion and analysis and related CEO and CFO certifications for the third quarter ended on September 30, 2010, would be delayed beyond the filing deadline of November 12, 2010.
On August 4, 2010, Ambrilia announced that the filing of its interim financial statements, management's discussion and analysis and related CEO and CFO certifications for the second quarter ended on June 30, 2010, would be delayed beyond the filing deadline thereof.
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Bloomberg Sees Debt Pricing Spreads As Much-Tighter Than The Reality I've Foreseen Bloomberg just ran a story suggesting that -- because a Merck note issued back in June 2009 (see archived image of the tranches in the 2009 deal, at right), due in June 2015 last traded (in the aftermarket) on December 2, 2010 at a yield of 1.85 percent, or 27 basis points over five year Treasuries at the time -- maybe today's likely $2.5 billion dual-tranche offering will get done at around 1.85 percent on the 2015 portion.
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miRNA Research to Experience Rapid GrowthROCKVILLE, MD--(Marketwire - December 6, 2010) - MarketResearch.com has announced the addition of RNCOS's new report, "Global miRNA Market Outlook," to their collection of Biotechnology market reports.
For more information,
visit http://www.marketresearch.com/product/display.asp?ProductID=6000943
Currently, the research community is primarily focusing on the widespread chronic diseases such as Cancer, Hepatitis, and Diabetes. Additionally, miRNA and its role in various diseases are being studied from a genetic point of view. Success in these areas would eventually fuel the movement into other important and rare diseases
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Vertex is once again news on wall street..........
NEW YORK, Dec. 6, 2010 /PRNewswire/
-- Vertex Pharmaceuticals
(VRTX: $33.50) has been picked by Standard & Poor's Equity Research as its Focus Stock of the Week. VRTX carries S&P's highest investment recommendation of 5-STARS, or Strong Buy."Our recommendation is based on our positive outlook for Vertex's development drug telaprevir to emerge as a leader in new treatment paradigms for chronic hepatitis C," said Steven Silver, Biotechnology Equity Analyst at Standard & Poor's Equity Research. "We also view favorably Phase III results among prior treatment-failure patients, particularly in relapsers/partial responders, versus other late-stage development rivals. Vertex completed an FDA new drug application in November 2010 and requested a six-month priority review, which we view as likely to be granted in early 2011."
Silver observes that although VRTX shares are volatile, which he attributes to its significant cash burn rate related to pipeline investment and to a rapidly changing chronic hepatitis C competitive landscape, he expects Vertex to dominate the market over the near term, while aggressively advancing next-generation combination products of its own to support long-term market share. He also looks for Vertex to attract acquisition interest, as big pharma faces a patent cliff with few late-stage drugs with market potential as promising as what he sees for telaprevir.
To view a video of Mr. Silver discussing Vertex Pharmaceuticals Click Here
Continue reading...................
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Today published at FierceBiotech is an article on vaccines which are still in development. A few great examples: HCV, HIV/AIDS , MRSA , you might want to check it out.
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December 8, 2010 — 12:37pm ET
The Chinese government has made the development of its next-gen technology industries a big priority, and biotech is coming in for some star treatment.
China's economic minister recently tapped biotech as one of seven key industries that the government intends to foster over the next 10 years. Zhou Zixue now projects that biotech in China will grow at an annual rate of 24.1 percent between 2011 and 2015 before slowing down to a blistering hot 21.3 percent growth rate in the following five years.
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U.S. Commercialisation Partner Meda Presents Positive Xerese(TM)
Data at ASHP 12/8/2010 8 December 2010 --
Medivir AB (OMX: MVIR), the emerging research-based specialty pharmaceutical company focused on infectious diseases, today announced that its U.S. commercialisation partner, Meda, has presented virolology data from the Phase 3 programme on Xerese™/Xerclear®, Medivir’s unique cold sore treatment, at the 45th American Society of Health System Pharmacists (ASHP) Midyear Clinical Meeting & Exhibition, Anaheim, USA, 5-9 December 2010.
The poster1[i] summarised the results of virology assessments from two Phase 3 two-arm, randomised, multicenter, subject-initiated studies. These studies included immunocompetent adults and HIV-positive patients and examined the topical administration of the combination of five percent acyclovir and one percent hydrocortisone in a unique cream vehicle (Xerese™/Xerclear®) for the treatment of recurrent herpes simplex labialis. The data showed that Xerese™/ Xerclear® was well tolerated and did not give rise to acyclovir resistant virus.
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NEW YORK -(Dow Jones)- Merck & Co.'s (MRK) incoming Chief Executive Kenneth Frazier stressed the drug maker will stay focused on science and innovation when he takes the reins with the New Year.
The pharmaceutical giant needs to develop its pipeline in coming years as it faces generic pressure from key drugs and continues to digest last year's $49.6 billion takeover of Schering-Plough. Frazier was named to the top spot of the drug maker Tuesday
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MedfusionRx is based in Birmingham, Ala., and provides clinical services to more than 9,000 patients with complex clinical conditions, SXC said in a statement, including cancer, multiple sclerosis and hepatitis C.
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Merck & Co invests in ‘smart’ insulin
US drugmaker Merck & Co has agreed to buy SmartCells, a US biotech working on a ‘smart’ insulin product for the treatment of diabetes designed to respond to blood glucose levels. SmartCells shareholders will receive an upfront cash payment and additional payments totalling up to $500 million (£320 million) if key goals on the route to commercialisation of the product are achieved. The company says the approach could lead to a reduced risk of blood sugar levels in patients with diabetes falling to dangerously low levels.
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Then there's the hepatitis C treatment called Telaprevir – it's not yet commercial, but we expect it to be soon. It was discovered by Vertex Pharmaceuticals and will be sold in Europe by Johnson & Johnson. Since this drug shortens the treatment period for hepatitis C and improves the treatment response, we expect it to be a big commercial success.
Expect to Commence Public Offer Prior to 10 December 2010Reported by redOrbit on Wednesday, 1 December 2010
NEW BRUNSWICK, N.J. and LEIDEN, the Netherlands, /PRNewswire-FirstCall/ --* *Johnson & Johnson (NYSE: JNJ) and Crucell N.V. (NYSE Euronext, Nasdaq: CRXL; Swiss Exchange: CRX) provide the following joint update on the preparations for the intended public offer by JJC Acquisition Company B.V., a subsidiary of Johnson & Johnson, for all ordinary shares and American depositary shares of Crucell (the Offer) and on the status of the manufacturing issues in Crucell's Shingal facility in Korea previously announced by Crucell (the Korea Manufacturing Issues)
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Seattle Genetics Nears Finish Line with SGN-35
As reported by Bloomberg, Seattle Genetics and its partner Takeda are expecting to apply for approval of their antibody drug conjugate, SGN-35, for the treatment of lymphoma when the latest clinical data is reported next week. SGN-35 will then be able to beat Roche's own ADC, known asT-DM1, to market (albeit for a different clinical application) and become the only ADC approved by the FDA at that point. A previous ADC, Mylotarg, was withdrawn from the market earlier this year by Pfizer. SGN-35 is expected to generate as much as $420 M annually by 2015 if approved.
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Week Of Dec 1st,
Inhibitex: A Biotech Gem in the Enormous Hepatitis C Market
November 30, 2010 Share Email this Article
By James Altucher.comI think the best way investors can get an edge is to focus on underfollowed small-cap companies with enormous potential markets and the following attributes:
• Good arbitrages between potential value and current value (by looking at other companies in the sector)
• Good co-investors who are experts in the space and are buying shares.
I've been looking at a small-cap stock in one of the largest sectors of biotech - cures for Hepatitis C. Inhibitex (INHX) has a $180mm market cap, $24mm in cash, very favorable comparisons when placed side by side with its competitors (its main competitor is one year ahead of them in FDA trials but has a $1.5bb market cap, over 8 times bigger), and good institutional investors who have been steadily increasing their holdings.
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In 2011, the company will have seven Hepatitis-C drugs in human clinical trials. And though it's "too early to put these drugs into our financial model," it could be a valuable area, says Evan McCulloch, manager of the Franklin Biotechnology Discovery Fund.
For now, HIV drugs remain Gilead's bread and butter.
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More On :Vertex Submits NDA for Telaprevir in Treatment for Hepatitis C
Posted on: Tue, 30 Nov 2010 01:18:36 EST
Symbols: VRTX
Nov 30, 2010 (Close-Up Media via COMTEX) --
Vertex Pharmaceuticals Inc. announced that it has completed the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for telaprevir, Vertex's investigational treatment for people with hepatitis C.
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Merck & Co President Kenneth Frazier will succeed Richard Clark as the U.S. drugmaker's chief executive officer, with the enviable task of bringing to market an array of experimental drugs deemed second to none by many industry analysts. At a time when Merck and its rivals are girding for costly patent expirations on their biggest drugs, the Schering-Plough deal gave Merck numerous drugs in late-stages of testing that are deemed potential blockbusters.
They include a blood clot preventer and a promising treatment for hepatitis C. Merck has itself been developing a medicine to raise "good" HDL cholesterol that analysts believe could fetch annual sales of $5 billion or more.
Frazier, who will become the only black CEO among large U.S. and European drugmakers, also sits on the board of Exxon Mobil Corp and Pennsylvania State University.
Clark became CEO in 2005, when the company was reeling from the Vioxx withdrawal.
As Merck's head of manufacturing, Clark was a fairly obscure figure when he was picked to replace then-CEO Ray Gilmartin in 2005.
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We want to talk about several companies that are gaining some recent momentum. They all have catalysts that investors should be watching for.
Inhibitex, Inc. (NASDAQ: INHX). They also recently initiated a Phase 1b trial in Chronic Hepatitis C(HCV) and results should be expected sometime in early 2011.
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Mutual funds’ ties to so-called expert networks that have been probed as part of an insider trading investigation may undermine efforts by the industry to stem three years of client withdrawals from stock funds.
Janus Capital Group Inc. and Wellington Management Co. were among firms that received requests for information last week as part of an insider trading investigation involving hedge funds as well as mutual funds. None of the companies have been accused of wrongdoing.
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Nov 02, 2010 2:30 pm
Vertex is getting some help from collaborators, Johnson & Johnson’s (JNJ) Tibotec subsidiary and Mitsubishi Tanabe Pharma. If the drug gets approvals, Johnson & Johnson would sell it in Europe, South America, Australia and the Middle East, while Mitsubishi will market it in Japan and other parts of Asia. The worldwide market for this drug is eye-popping: 180 million estimated infections.But Vertex retains the rights to sell the drug in North America, and is in a race with Merck & Co. (MRK) to get approval and sell its treatment. At a weekend medical meeting focused on liver ailments, both companies presented study results of their new treatments (Merck’s is called boceprevir).
Both drugs were shown to be effective in trials conducted by the companies. But which drug is more effective is open for interpretation. While these studies are being debated by the medical community, some Wall Street analysts are saying Vertex’s drug appears to be better - an early victory for Vertex and a challenge for Merck.
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Week Of November 22nd
Re Merck's Remicade® Rights: EU Draft Rules To Allow BioSimilars Competition In EU Sooner? va von Schaper and Naomi Kresge, writing for Bloomberg overnight, have a story out about the much anticipated EU draft regulations that will govern the process for seeking approval to sell "generic" versions of bioscience therapies generally
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Significantly Shortens Duration Of Treatment And Vastly Improves Chances Of A Cure Says RBC Capital Biotech Analyst
This 81 page feature contains expert industry commentary through in-depth interviews with public company CEOs, Equity Analysts and Money Managers. The full issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online.
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Nov 24, 2010 2:45 pm
With little fanfare Ligand Pharmaceuticals announces its big pharma partnership for a Hepatitus C has treatment has ended.
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Biosimilar Antibodies- Another Win For Teva Pharmaceuticals
Already the undisputed leader in generics for small molecule drugs, Teva stands to benefit enormously as biosimilars begin to gain momentum. Laws passed in recent years have paved the way for the approval of follow-on versions of biologic medicines. The EU is leading the way with 13 biosimilars approved compared to just one in the US through their respective approval processes. While these rules only applied to simpler protein therapeutics for now, the EU is set to release a new set of requirements for the development of follow-on antibodies.
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SAN DIEGO (AP) - Apricus Biosciences Inc. said Monday it reached an agreement with the Food and Drug Administration on the design of a trial for a potential liver cancer drug, making approval more likely if the study is successful.
The company said it will conduct a one- to two-year study on around 218 patients with advanced hepatocellular carcinoma, the most common type of liver cancer. Apricus will select patients who have been treated with the drug Nexavar but are no longer responding to it, and for whom surgery is not an option. Patients in the study will receive a combination of PrevOnco, Nexavar, and the chemotherapy drug doxorubicin, or Nexavar, doxorubicin, and a placebo.
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Vertex Files for Hep C Drug Approval
By Adam Feuerstein
Tickers in this article:
Vertex seeking FDA approval for Hep C drug telaprevir with six-month review.
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Michael O’RiordanAuthors and Disclosures
Over the six-month period, the drug and device companies made $35.7 million in payments, with almost half of that money going to physicians, the Boston Globe reported Monday. Dr Mary Ann Asbell, a Cambridge-based physician, earned the most money from the drug and device companies, taking in $194 275, all from Genzyme Corp. Second on the list was cardiologist Dr C Michael Gibson (Beth Israel Deaconess Medical Center, Boston, MA) who earned $188 617 from six different companies, including Bristol-Myers Squibb, Daiichi Sankyo, Eli Lilly and Company, Ortho-McNeil, Schering Corporation, and The Medicines Company.
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By Adam Feuerstein
Adam Feuerstein's take on the biotech sector's hits and misses during the week ended Nov. 19, 2010.
11/20/10 - 08:00 AM EST
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The latest insider trading investigation is focusing on the new hub of Wall Street information: independent research networks that pay so-called experts for information on public companies.
What is it with Wall Street these days that it won't let a record stand for the usual amount of time? First, Marc Dreier gets one-upped by Bernie Madoff. Then, Bear Stearns gets bested by Lehman Brothers. And now the Galleon insider trading scandal—only a year old!—looks like it's going to get dusted by the latest insider trading probe on Wall Street.
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Amgen rumored to be considering acquisition of Swiss biotech firm Actelion.
Roche
cuts 4,800 jobs in a corporate restructuring that also axes the company's research efforts into RNAi drug development. (via Pharmalot, In the Pipeline)
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Merck aims to bring existing products to emerging markets.
"Treatment and diagnosis rates are extremely underdeveloped. For example, Hepatitis C has had a cure for many years but the number of people diagnosed and treated is tiny," he said.
. diseas,e.s in Asia
/;.Week Of November15th
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U.S. Probing Insider Trading Rings: Reporthedge funds and mutual funds," the Journal reported. NEW YORK (TheStreet) --
Federal officials are investigating alleged insider trading rings encompassing hedge funds, analysts and investment bankers that profited to the tune of millions of dollars in illegal profits, according to a report on The Wall Street Journal Web site. Earlier this month, a French doctor was arrested and charged with tipping off a hedge fund manager in late 2007 and early 2008 about problems with a clinical trial involving a hepatitis
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WSJ: Massive Insider Trading Investigation Coming To A Head -- Grand Juries Empaneled, And Hearing Evidence
While it is not news that the SEC has been formally investigating unusual trading patterns prior to the announcement of the Schering-Plough into Merck transaction, (circa March of 2009), the scope of that investigation was largely unknown -- until now. A fine piece of investigative journalism is evinced here, by Susan Pulliam, Michael Rothfeld, Jenny Strasburg and Gregory Zuckerman -- for the WSJ, tonight. This may well turn out to be largest insider trading bust in history. Apparently, Schering-Plough-Merck was only a small part of the much larger puzzle (and thus far, no one at either company is known to be a target in this investigation). Apparently, wide rings of dishonest industry insiders, traders and hedge fund managers were swapping information -- allegedly for illicit profits. That is the SEC's theory -- or so it would seem. Do go read the whole Wall Street Journal article
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Pharma Emulating Biotech to Boost R&D Productivity
Faced with multiple challenges of patent expirations, generic competition, increased government regulation, and most of all- low R&D productivity, many large pharmaceutical companies have decided a solution to their problem is to reorganize their research organizations to more resemble that of smaller biotech companies.
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HCV Drug Development Progress
Large, unmet needs in medicine have always spurred innovation in novel drug development. A textbook case of this can be found in the effort to fight Hepatitis C (HCV) infection. Hepatitis C is a blood borne virus that primarily affects the liver. The virus triggers an immune response – one that the virus almost always successfully evades– causing liver inflammation and scarring. Slowly, over a period of 20-30 years in most cases, the scarring can progress to decompensated cirrhosis, liver cancer and eventually liver failure. Lack of general knowledge regarding the disease in both the patient and healthcare provider population has created an environment of chronic underscreening, underdiagnosis and lack of proper treatment.
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the drugmaker competing to develop a new hepatitis C medicine, rose the most in four months in Stockholm trading after its drug reduced the virus to undetectable levels in patients who failed earlier treatment.
After 24 weeks, 86 percent of patients who had only partially responded to earlier treatment had undetectable virus levels after taking TMC435 alongside standard care, the Huddinge, Sweden-based company said in a study published today. That compared with undetectable levels in 19 percent of patients receiving a placebo.
Shares rose as much as 9.2 percent.
Medivir is developing TMC435 with Tibotec Pharmaceuticals. The drugmaker, a unit of New Brunswick, New Jersey-based
Johnson & Johnson, also is working simultaneously with Vertex Pharmaceuticals Inc. on a new hepatitis C drug.
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Diagnostic co Exalenz signs deal with PfizerCEO Steven Eitan: Some of the tests that the BreathID system makes possible will replace current invasive tests.17 November 10 12:16, Hillel KorenExalenz Bioscience Ltd. (TASE:EXEN) has signed a cooperation agreement with Pfizer Inc. (NYSE: PFE; LSE: PFZ) to use Exalenz's BreathID diagnostic device in a Phase II clinical trial of an experimental drug for the treatment of hepatitis C.OraSure Technologies Receives Popular Science "Best of What's New" Award for OraQuick(R) HCV Rapid Antibody TestOraQuick(R) HCV Rapid Antibody Test Named One of the Top 100 Technical Innovations of the Year
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BETHLEHEM, Pa., Nov 17, 2010 (GlobeNewswire via COMTEX) -- OraSure Technologies, Inc. /quotes/comstock/15*!osur/quotes/nls/osur (OSUR 4.49, -0.04, -0.88%) , the market leader in oral fluid diagnostics, today announced that the editors of Popular Science have named the OraQuick(R) HCV Rapid Antibody Test one of the top technology innovations of 2010. As a winner of a "Best of What's New" Award, the OraQuick HCV Rapid Antibody Test was recognized for its technology and being the first ever rapid, point-of-care test approved by the FDA for the detection of antibodies to the HCV (hepatitis C) virus.A photo accompanying this release is available at http://www.globenewswire.com/newsroom/prs/?pkgid=8335
NJ biotech firms g.et. tax credits
NJ biotech firms get tax credits
Nov 2010 16:33:36 EST
Nov 16, 2010 (Asbury Park Press - McClatchy-Tribune Information Services via COMTEX) --
U.S. Sen. Robert Menendez, D-N.J., announced Monday that 133 small New Jersey biotech companies would be receiving more than $53 million in federal tax credits and
grants
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The purpose of the Qualifying Therapeutic Discovery Project is to support development of new biotechnology by granting tax credits of up to 50 percent of small firms'
investments
in qualified projects that have the potential to address unmet needs and lower health-care costs. The program is open only to firms with no more than 250 employees
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As a result of cost structure adjustments and improvements in efficiency and productivity, Roche is planning to reduce its workforce by 4,800 positions worldwide, or about 6% of the Group’s current workforce of approximately 82,000 employees. Some reductions will be handled through normal attrition. In addition to the planned reductions, the company anticipates transfers of roughly 800 jobs internally and approximately 700 positions to third parties. The combination of planned job reductions and transfers is expected to affect about 6,300 jobs overall
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This collaboration is recited -- in the morning's press release -- as being six-months old, now. That corresponds to the moment when B + L Chairman Fred Hassan installed Brent Sauders (fellow legacy Schering-Plough alum) as his CEO/President/proxy at B + L. Not surprisingly, the VP of Research at NiCox is a long-time legacy Schering-Plough cohort of both Hassan and Saunders, to boot: ". . .Before joining Nicox, Ennio Ongini held various senior level positions at the Schering-Plough Research Institute, the most recent of which was Director of the research center at the San Raffaele Science Park in Milan. . . ." Cozy continue reading...
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Eli Lilly and the Cyclical Business of Drug Development
What people seem not to have noticed with Lilly’s acquisition of Avid Radiopharmaceuticals is the significance of the company’s diversification into the diagnostics business. Until now, Lilly had been purely involved in drug discovery. True, it has collaborations with Dx developers, in particular GE for molecular diagnostics, and Almac for a companion diagonostic to its cancer drug, Alimta; but Avid will be its only wholly owned diagnostics business. This is particular important considering Lilly has eschewed generics and is determined to solve its patent problems without a big merger.
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The defendant called “Tipper X” in the Galleon Group insider-trading case and a co-defendant agreed to cooperate with the government’s probe after pleading guilty, U.S. prosecutors said.
Tom Hardin, the former Lanexa Global Management trader referred to in court papers as “Tipper X,” pleaded guilty Dec. 21 in federal court in New York to conspiracy and securities fraud, according to a plea agreement and criminal information unsealed yesterday.
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Week Of November 8th
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The complaints against Benhamou allege that his tips allowed the hedge-fund
firm to sell shares in Human Genome Sciences Inc. ahead of negative news about the company's trial of a drug for hepatitis C, the liver disease .
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November 11, 2010
Drug discovery and development company SCYNEXIS, Inc. recently announced that the Company has been awarded four grants totaling $977,917 under the U.S. Federal Government's Qualifying Therapeutic Discovery Project (QTDP). SCYNEXIS is developing a proprietary internal pipeline of cyclophilin inhibitors, a class of drugs that hold significant potential for the treatment of a broad range of diseases. The Company's lead candidate from the platform, SCY-635, is currently in clinical trials for the treatment of hepatitis C virus (HCV). The grant applications are related to the development of four of the Company's cyclophilin inhibitor
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Biotechnology investors are always hungry for news that could keep them abreast of what's new and what the latest hot stocks are in this arcane industry. So, a conference that opens today in Boston, sponsored by the American Association of the Study of Liver Diseases, may provide some exciting updates. Usually attended by hundreds of scientists, researchers, physicians and executives of biotech companies, it's considered the premier gathering on the science and practice of hepatology because it provides a glimpse into the latest findings on new and novel liver drugs.See full article from DailyFinance:
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BMS donates diabetes money
The charitable arm of pharma company Bristol-Myers Squibb, the Bristol-Myers Squibb Foundation, has said it will
commit $100 million (£62 million) over the next five years as part of an initiative to help patients with type 2 diabetes with disease management.
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Video Of The Week
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Kahn Brothers Group Sold Merck To Buy Pfizer In Q3 2010: SEC 13F Filing
Kahn Brothers Group now holds twice as many Pfizer shares, as it does Merck shares. The institutional investor sold some 17,000 shares of Merck in the third quarter, while it bought up some 182,000 Pfizer shares. See this smallish Bloomberg item; or read the Kahn Brothers Group's SEC filing, just uploaded this morning
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In September 2010, Merck Recalled PegIntron® RediPens™ In the US

Here's another tidbit of previously undisclosed news, from the Merck SEC Form 10-Q, just filed (at page 39). To my knowledge, Whitehouse Station hadn't officially acknoweldged this voluntary US recall -- though we had reported on the likely Hong-Kong source of the PegIntron® RediPen™ problem back in September -- in real time:
. . . .In September 2010, the Company initiated a voluntary recall of PegIntron single dose RediPen injection in the United States after consultation with the FDA, resulting in a reduction to revenue in the third quarter of approximately $25 million representing estimated sales returns. In addition, the Company recognized a charge of approximately $30 million in Materials and production primarily for inventory discard costs. The recall is being conducted as a precautionary measure due to a third-party manufacturing issue that could affect a small number of RediPens. The recall is specific to PegIntron RediPen and does not affect PegIntron vial products. . . .The overall amount is small but voluntary recalls should always be officially disclosed, for the simple fact that patient safety is at stake..
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GSK settles $750 million whistleblower suit
GlaxoSmithKline
(GSK) has agreed to pay $750 million (£471 million) to settle the criminal and civil charges relating to the manufacture of adulterated drugs at the company’s now closed plant at Cidra, Puerto Rico. Under the provisions of the US False Claims Act, the whistleblowing former staff member who initiated the suit will receive approximately $96 million.
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First Week In November
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With so much attention paid to the relative merits of novel protease inhibitors, telaprevir and boceprevir, at the recent American Association for the Study of Liver Diseases (AASLD) meeting, arguably the biggest beneficiary from the conference was Pharmasset (VRUS).
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VideoFrontPoint Said to Be Hedge Fund Tipped on Albuferon
Nov. 2 (Bloomberg) -- Bloomberg's KatheriBurton talks about the arrest of Dr. Yves Benhamou on insider trading charges for allegedly tipping ...
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by Bloomberg
Today the (TheStreet) asked this question -- "How do a French doctor and a Connecticut hedge fund manager strike up a friendship that leads to the doctor being charged with passing along inside information about a hepatitis C drug trial?"Adam Feuerstein writes;"This is likely how two men of disparate backgrounds -- Benhamou, a doctor and widely published medical researcher who treated hepatitis C patients from an affluent suburb of Paris, and the hedge fund manager who lived and worked in Connecticut but who is not identified in court papers, got to know each other".
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Taking vitamin E supplements doesn’t reduce the risk of stroke, and may even be harmful, an analysis of previous research found.
The vitamin raised the risk of a severe type of stroke by 22 percent, while it lowered the risk of a milder kind by 10 percent, according to the
study, published today in the British Medical Journal.
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Great Article On New HCV Drugs :Pharmasset Riding High on Nucs
Pharmasset is a biotech company focused on the development of HCV therapeutics. It has multiple drugs in development, all based on its core strength in RNA nucleoside analog chemistry.
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NEW YORK (TheStreet) -- The Hippocratic Oath doesn't say anything about doctors and insider trading, or best practices for doctors when advising hedge funds, but it may have to add a clause after the insider trading case launched this week against a French doctor and involving a drug trial from Human Genome SciencesBad Medicine: .
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“During this quarter we demonstrated progress in many key areas across the company. In our clinical programs, we recently presented positive Phase 1 data for our two internal drug candidates - IMO-2125 in null-responder HCV patients and IMO-3100 in healthy subjects. In addition, our collaborator, Merck KGaA, initiated a Phase 1b clinical trial to evaluate our partnered drug candidate
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Because there will still be some patients who won't respond to Telaprevir®, or Boceprevir®, J&J (via a The Medicines Company-researched drug candidate, thus the TMC nomenclature) is advancing a powerful alternate candidate, still about four years away from market, to follow in Telaprevir's wake:
. . . .In addition to partnering with Vertex on Telaprevir, Johnson & Johnson is developing its own Hep C drugs, including TMC435. A phase IIb study being presented Monday shows that between 79% and 86% of patients treated with TMC435 and standard of care responded well enough to stop all therapy after 24 weeks. This interim result for TMC435 looks better than the 58% and 65% of telaprevir-treated patients who were able to stop therapy after 24 weeks, except that J&J used a more liberal definition of response, which inflates its numbers. Patient treated with higher doses of TMC435 also reported increases in certain liver enzymes levels, raising safety concerns about the drug. . . .
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An article by Robert Langreth published at forbes today points out the reasons why the HCV virus is difficult treat.'"A bigger reason, says Vertex’s Kauffman, is that hepatitis c is a hugely efficient reproducer. It produces 1 trillion new viral particles a day–a far greater replication rate than HIV. Hepatitis C also makes many mistakes when it copies itself"
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Doctor Charged With Tipping Hedge Funds on Human Genome Hepatitis Research A French doctor who worked as a consultant for Human Genome Sciences Inc. has been charged by the U.S. with insider-trading for allegedly tipping off a hedge fund about negative results of Albuferon drug trials.
Dr. Yves Benhamou, 50, of France, was arrested today on two federal charges filed by prosecutors in the office of Manhattan U.S. Attorney Preet Bharara, the FBI in New York said. Human Genome Sciences, or HGSI, is a developer of gene-based drugs.
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Oct 31
Oct. 30 (Bloomberg) -- Vertex Pharmaceuticals Inc. and Merck & Co. said their experimental drugs for hepatitis C cured more patients than traditional treatment, and many people were able to take a shorter, less toxic course of therapy.
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Today From Bostom (TheStreet) -- Reported on Telaprevir at the American Association for the Study of Liver Disease (AASLD). The article is presented for investors, but has data we all can use.Adam Feuerstein writes;" Vertex Pharmaceuticals: Telaprevir was the superior hepatitis C drug coming into AASLD and no data or information released over the weekend, including from Merck and its competing drug boceprevir, changed that view. If there's a debate left to have about telaprevir vs. boceprevir in hepatitis C, it's forecasting the market share each drug may garner once both are approved next year".
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Oct 30th
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10/29/2010-A number of pharma firms including Merck (NYSE:MRK), Johnson & Johnson (NYSE:JNJ) and Bristol-Myers Squibb (NYSE:BMY) are in a heated race to come up with newer more affective treatments for hepatitis C.
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Inhibitex to Host Conference Call to Report Third Quarter Financial Results on November 9, Inhibitex, Inc Conference Call Tuesday
ATLANTA--(BUSINESS WIRE)--Inhibitex, Inc. (NASDAQ: INHX) announced today that it will host a conference call on Tuesday, November 9, 2010 at 9:00 a.m. EST to review the Company’s third quarter financial results and provide an update on recent corporate developments. The Company will issue a press release regarding its financial results on the same day, prior to the conference call.
Webcast Information
To access the conference call, please dial (877) 407-9210 (domestic) or (201) 689-8049 (international). A replay of the call will be available from 11:00 a.m. Eastern Standard Time on November 9th until December 10, 2010 at midnight. To access the replay, please dial (877) 660-6853 (domestic) or (201) 612-7415 (international) and reference the account # 286 and the conference id # 359917. A live audio webcast of the call and the archived webcast will be available in the News and Events section of the Inhibitex website at
http://cts.businesswire.com/.
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Today bloomberg published an article on the aspirations of Bristol-Myers and Gilead ; the two drug companies are hoping to find the same success with HCV they have with their top selling oral combination for AIDS.
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But sales of other drugs went down. PegIntron, which Merck got from Schering-Plough, dropped 15%. The company has a next-generation hepatitis C drug, boceprevir, in development, but it sure looks like Vertex Pharmaceuticals' (Nasdaq: VRTX) telaprevir will beat it to the marketplace.
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On a fundraising roll, Dynavax Technologies Corp. priced a $39.1 million public stock offering as beleaguered hepatitis B vaccine Heplisav wraps up its final Phase III trials and marches toward a biologics license application filing next year.
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Hey! What The. . .? No More Puerto Rico Tax-H

aven Manufacturing -- For Merck?New Merck (in part via legacy Schering-Plough subsidiaries) operates at least SIX multibillion dollar direct or indirect subsidiaries focused on manufacturing (and some research) operations in the former "tax haven" of Puerto Rico, as PR Law 154 has taken effect. That's right -- former tax haven

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From Market Watch /"We are pleased with the third quarter as well as our overall execution during Merck's first year as a combined company following the merger," said Richard T. Clark, chairman and chief executive officer. "Our key products are performing well, and at the same time we are launching new products, advancing our robust R&D pipeline and achieving our important merger synergies. One year later, Merck is a much stronger, unified organization that is well-positioned for the future."

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This Week .
Oct 25 2010

Kadmon Pharmaceuticals Acquires Three Rivers Pharmaceuticals
NEW YORK, NY--(Marketwire - October 25, 2010) - Kadmon Pharmaceuticals announced today that it has acquired Three Rivers Pharmaceuticals, a privately held specialty pharmaceuticals company based in Warrendale, Pennsylvania. Three Rivers will serve as the commercial and operational cornerstone for Kadmon, a privately held biopharmaceutical company based in New York City. Terms of the agreement were not disclosed.
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The Wall Street Journal hinted today why drug companies like Bristol-Myers and Johnson & Johnson are in the infectious disease business. (Note Vertex began the clinical development of Telaprevir in 2004 and is collaborating with Johnson & Johnson and Mitsubishi Tanabe Pharma) According to Jonathan D. Rockoff from the WSJ, patients in the U.S. can't afford the high cost of prescriptions and the European governments with their own financial obstacles are working to control price increases. The drug business is taking a hit because of the economy. The business of antiviral agents are giving these drug companies a shot at some real cash flow. The buzz is J&J may expand in infectious disease, as for Bristol-Myers they came out with their own sad earnings today. (See more on Bristol-Myers at Wall Street Journal )
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NEW YORK Oct 25 (Reuters) - Vertex Pharmaceuticals on Monday reported a wider third-quarter loss as it stepped up research on its promising experimental treatment for hepatitis C, and said it plans to seek U.S. approval for the medicine in coming weeks.
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Sam Waksal, is the former CEO of ImClone Systems, whose insider trading lead to spending time in prison along with Martha Stewart, remember? Announced today; "Waksal said his drug company Kadmon Pharmaceuticals has bought the privately held Three Rivers Pharmaceuticals, and that its treatments for hepatitis C, infections and cancer will be the backbone of his new enterprise".
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TheStreet reported Monday that Vertex disclosed a viral load rebound in their phase IIb study. The companies two experimental HCV drugs, VX-222 and Telaprevir needed to be modified after the breakthrough during the first four weeks of treatment."BREAKTHROUGH: the return of detectable viral load or high ALT levels in a person who had previously achieved a good virological or biochemical treatment response".
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CAMBRIDGE, Mass., Oct 25, 2010 (BUSINESS WIRE) -- --- All patients will receive telaprevir-based combination therapy -Patient screening for enrollment in the OPTIMIZE study is expected to start in November 2010.Vertex Pharmaceuticals Incorporated today announced the initiation of a Phase 3b study called OPTIMIZE that will evaluate twice-daily (BID) dosing of a telaprevir-based combination regimen in people chronically infected with genotype 1 hepatitis C virus (HCV) who have not been treated previously. This is the first Phase 3 study to evaluate twice-daily dosing of a protease inhibitor for the treatment of hepatitis C. OPTIMIZE will not include a control arm of pegylated-interferon and ribavirin alone.
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Direct-acting Drugs Danoprevir plus RG7128 Suppress HCV without Interferon
SUMMARY: Results from the INFORM-1 trial, which evaluated 2 experimental agents that target different steps of the hepatitis C virus (HCV) lifecycle, showed that a combination of direct-acting drugs can suppress viral replication without interferon or ribavirin.
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Looking Into Pharmas
Vertex Pharmaceuticals Incorporated engages in the discovery, development, and commercialization of small molecule drugs for the treatment of serious diseases worldwide. Its product pipeline includes Telaprevir (VX-950), a Phase III clinical trial product for the treatment of hepatitis C virus (HCV) infection; VX-222, a Phase IIa clinical trial product targeting HCV infection; and VX-985 and VX-759, which are in Phase I clinical trials for the treatment of HCV infection.
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Please click on the link to download the release:Intercell and Romark join forces in combining therapies against Hepatitis C (.pdf, 195kB)-- The companies are designing a treatment that combines Intercell's investigational Hepatitis C vaccine, IC41, with Romark's antiviral drug, nitazoxanide.-- A combination Phase II trial is expected to start in H1/2011.
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Aethlon Medical Initiates Patient Enrollment of Hepatitis-C Virus (HCV) Clinical StudiesSAN DIEGO, Oct. 21 /PRNewswire-FirstCall/ -- Aethlon Medical, Inc. (OTC Bulletin Board: AEMD), the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, announced today it has established primary clinical endpoints and clarified efficacy assessments related to a study that will evaluate the use of the Aethlon Hemopurifier® in combination with standard of care (SOC) HCV drug therapy. As a result, Aethlon will now initiate the recruitment of candidate patients and begin exporting its Hemopurifier® for clinical purposes
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19 October 2010NeurogesX, Inc. (Nasdaq: NGSX), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, announced plans to pursue a U.S. label expansion for Qutenza® (capsaicin) 8% patch...
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This Week Oct 5
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Cramer and His Take On Hepatitis C Drugs
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From Cramer :"Pharmasset, as I mentioned, is much more speculative, as its most advanced product will enter only Phase III trials next year and won’t hit the market until 2014. This treatment will serve patients who don’t respond to the new hep C therapies from Merck and Telaprevir. What Pharmasset does offer that Vertex does not is a seeming built-in acquirer in Roche, which has licensed the drug that Pharmasset is working on. Also, the company has another hep C treatment in Phase IIB trials, with data expected over the next six to 12 months."
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Bristol-Zymo Deal Nears Completion
Bristol-Myers with full ownership of pegylated-interferon lambda (formerly known as IL-29)
"PEG-Interferon lambda, once launched, should augment Bristol-Myers’ top line. The HCV market is lucrative with a huge unmet need. Chronic HCV infection is a leading cause of cirrhosis, liver failure and hepatocellular carcinoma across the globe. Furthermore, HCV is the main reason behind liver transplantation. We believe that the successful development and commercialization of the candidate should further boost the top line at Bristol-Myers".
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Benlysta - FDA's Top 10 Blockbuster Decisions
"By the time the FDA was finished trashing Human Genome Science's troubled hepatitis C drug Zalbin with a complete response letter last week, it would have been hard to find anyone surprised by it"
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Roche Broadens Hepatitis C Franchise With Drug Buy
Roche said Intermune's experimental medicine danoprevir "has shown promising efficacy in preclinical and early clinical development" and should "increase flexibility" to develop and market Roche's portfolio of drugs against hepatitis C, an infection of the liver that affects around 180 million people worldwide.
Although the market for hepatitis C drugs is crowded, new and more efficient drugs promise players to grab a substantial share of this market place, analysts say. With blockbuster Pegasys, Roche already owns a drug that treats hepatitis C, which is especially rife in Asia. The company is also developing experimental compound RG7128, a nucleosidic polymerase inhibitor which has shown a promising resistance profile, Roche said.
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Blog Note.. Today I posted some info about RG7128 and genotype 3
Fatty Liver Disease, Genotype 3, Vitamin E and HCV
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J&J gains clout in vaccines
"The deal follows J&J’s purchase last year of a 17.9 per cent stake in Crucell, in an equity and investment alliance that focused on the Dutch company’s research into a universal flu vaccine and one for Hepatitis C."
Another bright spot for the industry is the anticipated introduction of several new treatments for diseases including melanoma, hepatitis C and multiple sclerosis, the report said. IMS expects five products each potentially worth at least $1 billion in annual sales to be approved and launched by the end of next year.
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Last Week Sept 27
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Vertex Edges Merck In First Round of Hepatitis C Fight
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This Article Is Worth The Click Folks
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Here’s what Howard Liang of Leerink Swann wrote in a note today:
“Apples-to-apples” comparison of boceprevir vs. telaprevir in treatment-experienced patients is possible for the first time and appears to favor telaprevir. In prior relapsers, SVR was 69%-75% for boceprevir vs. 83-88% for telaprevir. In what we would call partial responders MRK has a different definition, SVR was 40-52% for boceprevir vs. 54-59% for telaprevir. Cross-trial comparisons are always difficult but we believe the totality and consistency of both treatment-experienced and treatment-naïve data give an impression that telaprevir may be more potent."
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Merck today announced that final results from two pivotal Phase III studies of boceprevir, its investigational oral hepatitis C protease inhibitor, will be presented in oral plenary sessions at the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), which is taking place from Oct. 29 through Nov. 2 in Boston. Results for boceprevir in response-guided therapy strategies, which evaluated treatment durations shorter than current standard therapy, will be presented during the meeting. In total, more than 20 oral and poster presentations of clinical studies highlighting Merck medicines and investigational therapies for chronic hepatitis C virus (HCV) infection will be presented.
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From the last week in September
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From The : Wall Street Journal
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"There's a huge reservoir of people who made a few bad decisions many years ago. Now they're successful business people, lawyers, doctors, school principals, and they don't know they are carrying this," says Joseph Galati, medical director of the Center for Liver Disease and Transplantation at Houston's Methodist Hospital. In the meantime, he says, "they could be doing things like drinking alcohol that accelerate the disease or transmitting it to other people."
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Sept 27, 2010 /PRNewswire via COMTEX/ -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the launch of novel therapies for the treatment of Hepatitis C Virus (HCV), including Vertex/Johnson & Johnson/Mitsubishi Tanabe's telaprevir and Merck's boceprevir, will precipitate several changes in HCV treatment. According to Patient Flow in Hepatitis C Virus, surveyed physicians plan to initiate treatment in at least half of their "warehoused" HCV1 patients one year after novel therapies become available. Patient "warehousing" is a term that has been coined to characterize the phenomenon of HCV patients opting out of treatment with current standard of care in anticipation of new therapies; psychiatric events, adverse events and liver health are top reasons keeping patients away from current therapies.