As this week comes to a close we take a look back at the most relevant HCV headlines, including today's news with updates as the day progresses. Click here to view previous "HCV Weekly Rewind" articles.
Over at the Street journalist Adam Feuerstein answered a few questions for investors about the new data to be presented at this months liver conference. Check out his write up titled Biotech Stock Mailbag: All You Need to Know About Hep C Drugs.
Here's an excerpt:
Jackson P. asks, "Is there any data that has not leaked from EASL which will be important to the hepatitis C stocks?"
The EASL meeting kicks off officially April 18 and runs through April 22. As Jackson notes, I've written a lot about selective disclosure of research abstracts and data leaks leading up to the EASL meeting, but let's now focus attention on investor expectations for new data to be presented at the meeting and what it may mean for hepatitis C drug stocks.
First, just a bit of background to help frame the issues: Today's standard of care for treatment-naive hepatitis C patients is 12 weeks of Vertex Pharmaceuticals'(VRTX) Incivek (taken three times daily) plus six months of injectable interferon (once weekly) and a daily oral dose of ribavirin. Cure rates with the Incivek regimen range from 75% to 80%. For patients who achieve a rapid, early response to Incivek therapy, cure rates can get as high as 90%.
Read more at The Street
Jules Levin at NATAP highlights the interferon-free therapies to be presented at the EASL next week.
EASL Brief Preview, liver conference next week in Barcelona:interferon-free therapies
There are several additional important new HCV drugs for which updates are expected including Roche's protease danoprevir boosted with low dose ritonavir, Boerhinger Ingelheim's protease BI201335 & their NNRTI BI207127, TMC435 the potent protease from Janssen, alisporivir the potent cyclophillin inhibitor. In phase 3 development, the last stage before FDA approval are daclatasvir, BI201335, TMC435, Alisporivir & already started or about to start for GS7977, with others quickly planning to move ahead fast as well. There will also be an update on a the 3-drug oral regimen of BI201335+BI207127+ribavirn. And of course there will be more updates & reports at EASL on additional new HCV drugs in developmentContinue Reading @ NATAP
GS-7977 Phase 3 in Genotype 2/3 Started, in Gt1 Soon waiting for QUANTUM results, nucleotides & Other HCV Drugs
CORRECTION: The analysts reporting online is wrong regarding the BMS' NS5A+ GS7977 with or without ribavirin study. The presentation at EASL will report on the 24 week study, so the analysts report from the leaked abstract that the 12-week data is End Of Treatment is not correct. The 97% reported in the online leaked abstract is after 12 weeks on treatment that is of 24 weeks duration. There is a lagging cohort of this study that looks at 12 weeks total therapy, but this part of the study started later so results will be reported later.From jules: Nucleotides are considered an important component of an HCV therapy regimen because they are potent & are not associated with developing drug resistance easily at all. Its worth repeating that the recent Gilead announcement that in a small study of null responders patients had undetectable viral load at the end of 12 weeks treatment with GS7977+RBV but virologically failed after stopping therapy has been misinterpreted in that observers think this is a bad commentary on this class of drugs. NOT, this is not the case. First, the patients..Continue Reading @ NATAP..
Abbott HCV Drug Development Update
Official Title: A Randomized, Open Label, Multi-center Study to Evaluate the Antiviral Activity, Safety, and Pharmacokinetics, of ABT-450 With Ritonavir (ABT-450/r) in Combination With ABT-267 and/or ABT-333 With and Without Ribavirin (RBV) in Treatment-Naïve and Null Responder Subjects With Genotype 1 Chronic Hepatitis C Virus Infection
Recruiting A Study to Evaluate ABT-450 With Ritonavir (ABT-450/r) When Given Together With ABT-267 and With and Without Ribavirin (RBV) in Treatment-Naïve Subjects With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV)
A Randomized, Open Label, Multi-center Study to Evaluate the Antiviral Activity, Safety, and Pharmacokinetics, of ABT-450 With Ritonavir (ABT-450/r) in Combination With ABT-267 and/or ABT-333 With and Without Ribavirin (RBV) in Treatment-Naïve and Null Responder Subjects With Genotype 1 Chronic Hepatitis C Virus Infection
Recruiting A Study of ABT-450 With Ritonavir and ABT-267 and/or ABT-333 With and Without Ribavirin in Genotype 1 HCV Infected Subjects
Pharmacokinetics, Safety and Tolerability of the HCV NS5A Inhibitor ...
Apr 3, 2011 - The pharmacokinetics of ABT-267 were approximately dose-proportional with minimal accumulation following multiple dosing.
Abbott to Present Positive Phase 2 Results from Multiple Interferon-Free Studies of Combination Regimens for the Treatment of Hepatitis C - press release - (04/04/12)
Abbott hepatitis C combo impressive in small study: is the new standard of care 95% in naives? - (04/04/12)
More Hep C Articles @ NATAP...
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EASL In Todays News
Gilead Sciences' Hepatitis Drug in Spotlight at Major Medical Meeting
By Brett Chase
Apr 13, 2012
It’s just about showtime for Gilead Sciences (GILD) and its experimental hepatitis C drug.
When specialist doctors from around the world gather in Spain next week to learn about new drugs in development for liver diseases, data for Gilead’s GS-7977 will be closely scrutinized and among the most anticipated research presented. The company hopes to show it has a real potential winner of a drug to treat the liver-wasting virus hepatitis C.
The big medical meeting, the International Liver Conference, begins Wednesday, and some scientific abstracts have been released in advance of the five-day gathering. However, a pair of key studies for Gilead’s drug are still embargoed until presentations starting Thursday. Gilead and a host of rivals are trying to develop an all-oral and better treatment regimen for hepatitis C. There has been a lot of excitement in the medical community and the investment world over Gilead’s drug.
“We have very high expectations for GS-7977,” Stifel Nicolaus analyst Joel Sendek says in a recent note recommending Gilead’s stock.
He is counting on the drug to spur future growth. Gilead is so dominant among HIV drug makers (with about 70% of the treatment market) that it’s unlikely to expand as rapidly in the future, he says.
Gilead also begins losing patent protection on HIV drugs later this decade, which is a key reason the company is expanding into hepatitis. A better hepatitis treatment potentially would bring in billions of dollars in new annual revenue. Gilead clearly has high hopes for 7977 as it was the strategic drug acquired with the recent $11 billion takeover of Pharmasset. (See Gilead Plans $11 Billion Takeover of Pharmasset to Gain Hepatitis Drugs.)
Shares ofGilead are up 12% this year but fell earlier this week. The stock closed at $45.72 Thursday.
While there are a number of other companies vying for the next generation of hepatitis C treatments, none of them made such a big wager on an acquisition. Among the other companies racing to bring a new hepatitis drug to market: Abbott Laboratories (ABT), Bristol-Myers Squibb (BMY), Merck (MRK), Vertex Pharmaceuticals (VRTX), Idenix Pharmaceuticals (IDIX) and Roche (RHHBY.PK). Abbott was among the companies whose hepatitis research was released earlier in advance of the Spain conference and turned some heads with impressive study data. (See Abbott Laboratories Rises to Record High on Hepatitis Drug Study.) A Bristol-Myers drug is being tested with Gilead’s 7977 in research to be presented at the medical meeting.
Hepatitis C is being carried by millions of people and many of them don’t even know they have the virus. As many as 170 million people worldwide have a chronic infection, according to one estimate. More than 3 million Americans are estimated to be chronically infected, according to government figures.
Vertex and Merck launched two much improved treatments for the virus last year. The research focus now is to create a new class of drugs.
Twitter: @brettchase
Read more
press release
April 13, 2012, 6:00 a.m. EDT
Astex Pharmaceuticals to Present AT26893, a Novel Targeted Approach to the Treatment of HCV at EASL
DUBLIN, Calif., Apr 13, 2012 (GlobeNewswire via COMTEX) -- Astex Pharmaceuticals, Inc. /quotes/zigman/6481310/quotes/nls/astx ASTX +0.01% , a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics, announced that it will present data on AT26893, a novel, first-in-class, direct acting antiviral agent (DAA) against Hepatitis C Virus (HCV) at the 47th Annual Meeting of the European Association for the Study of the Liver (EASL): The International Liver Congress(TM), April 18 to 22, 2012 in Barcelona, Spain.
The following presentations are scheduled for Friday, April 20th from 12:30 to 2:00 pm during the poster session: Viral Hepatitis C: Experimental (virology)
-- Abstract No. 19057: Fragment based discovery and cellular validation of
a novel allosteric binding site on the full length HCV NS3/4a enzyme
-- Abstract No. 19064: Pre-clinical characterisation of a novel allosteric
inhibitor of the HCV full length NS3/4a protein
The NS3 protein is essential for viral replication and represents a validated HCV therapeutic target. Astex has used its fragment-based drug discovery approach, Pyramid(TM), to discover and target a novel allosteric binding site on the full length HCV NS3 protease - helicase enzyme. Compounds binding at this site have a novel mode of action and a different resistance profile compared to NS3 active-site protease inhibitors and these data will be presented at EASL. Astex scientists will also present data on the characterization of AT26893 that has entered formal preclinical development in preparation for an IND filing.
This research program, which has been supported with POUND2 million of funding from the Wellcome Trust Seeding Drug Discovery initiative, is wholly owned by Astex Pharmaceuticals.
Copies of these presentations will be available in the pipeline, presentations and publications section of the Astex Pharmaceuticals website, www.astx.com .
About Astex Pharmaceuticals
Astex Pharmaceuticals is dedicated to the discovery and development of novel small molecule therapeutics with a focus on oncology. The Company is developing a proprietary pipeline of novel therapies and is creating de-risked products for partnership with leading pharmaceutical companies. Astex Pharmaceuticals developed Dacogen(R) (decitabine) for Injection and receives significant royalties on global sales.
For more information about Astex Pharmaceuticals, Inc., please visit http://www.astx.com .
The Astex Pharmaceuticals, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=12273
This news release was distributed by GlobeNewswire, www.globenewswire.com
SOURCE: Astex Pharmaceuticals, Inc.
TGIF - This Weeks Updates
EASL
GS-7977-Gilead Bets on Hepatitis C Data to Back Pharmasset Deal
HCV News Ticker- EASL 2012-Hepatitis C Drug Abstracts Leak Ahead of EASL Confab
Stem Cells
UCLA-engineered stem cells seek out and kill HIV in living organisms
Big IdeaTurning Lymph Nodes Into Liver-Growing Factories
China’s stem-cell rules go unheeded
Research
**New Today From Medscape
New Therapies for Chronic Hepatitis C Infection
The objectives of this review were to identify new treatments that are in clinical trials. These include boceprevir and telaprevir which are in routine clinical use and form part of the American Association for the Study of Liver Diseases (AASLD) 2011 guidelines as well as drugs based on observational studies, improving/modifying ribavirin or interferon-based therapies, modifying the host response and finally the use of direct-acting antiviral agents (DAA).
A retrospective case-control study of hepatitis C virus infection and oral lichen planus in Japan
Spirulina platensis versus silymarin in the treatment of chronic hepatitis C virus infection. A pilot randomized, comparative clinical trial
Awareness
Chronic Hepatitis C-Could you have it?
Telaprevir - Boceprevir
VA-Taking Your Hepatitis C Triple Therapy 1-page handouts
One-page printable handouts for providers to give to patients who are taking one of the new hepatitis C drugs--boceprevir or telaprevir--with tips on how and when to take the medications, and what to do if you miss a dose.
Boceprevir handout
Telaprevir handout
VA National Hepatitis C Resource Centers
Todays News
Health Care Professionals Can Be Idiots Too
My problem is that I live with multiple chronic illnesses, including diabetes, fibromyalgia, chronic pain, cancer treatment late effects and, the biggest complication of all, dysautonomia. I have repeated these diagnoses ad nauseam--over, and over, and over--to my Hepatitis C treatment team. They nod, they write them down, but at the end of the day they just don't get it. They don't get that my pre-existing medical conditions are affecting my Hepatitis C treatment experience.....
Tuna linked to salmonella outbreak in 20 states
WASHINGTON — The government says a yellowfin tuna product used to make dishes like sushi and sashimi sold at restaurants and grocery stores has been linked with an outbreak of salmonella that has sickened more than 100 people in 20 states and the District of Columbia.
The Food and Drug Administration reported Friday that 116 illnesses have been reported, including 12 people who have been hospitalized. No deaths have been reported.
Moon Marine USA Corp. of Cupertino, Calif, also known as MMI, is voluntarily recalling 58,828 pounds of frozen raw yellowfin tuna. It was labeled as Nakaochi Scrape AA or AAA when it was sold to grocery stores and restaurants and is scraped off the fish bones and looks like a ground product.
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Online:
FDA release: http://tinyurl.com/7nsezo8
Hepatitis clinic follows juice recall
SourceThe Food and Drug Administration reported Friday that 116 illnesses have been reported, including 12 people who have been hospitalized. No deaths have been reported.
Moon Marine USA Corp. of Cupertino, Calif, also known as MMI, is voluntarily recalling 58,828 pounds of frozen raw yellowfin tuna. It was labeled as Nakaochi Scrape AA or AAA when it was sold to grocery stores and restaurants and is scraped off the fish bones and looks like a ground product.
___
Online:
FDA release: http://tinyurl.com/7nsezo8
Hepatitis clinic follows juice recall
Updated: April 12, 2012 2:15 PM
Hepatitis A drop-in immunization clinics will be held on Vancouver Island for people who have consumed Western Family brand Pomeberry Blend frozen berries in the past 14 days.
This follows a health alert issued by the BC Centre for Disease Control and a product recall. The product was distributed through Save-on-Foods and Overwaitea food stores in British Columbia, Alberta and Ontario and may also have been distributed to other provinces.
In Campbell River, drop-in immunization clinics will be held at the Campbell River Health Unit located at 200-1100 Island Hwy
- Friday, April 13, from 12-3 p.m.
- Saturday, April 14, 2-5 p.m.
The overall risk to the public is very low. If people consumed uncooked Pomeberry frozen fruit within the past 14 days and have not previously received two doses of hepatitis A vaccine or have already had hepatitis A disease they are eligible to receive hepatitis A vaccine.
This does not apply to other berries or juice blends purchased from Save-On-Foods or Overwaitea food stores.
For information on Hepatitis A, visit:
- Food Facts web page at: http://www.inspection.gc.ca/english/fssa/concen/cause/hepatite.shtml
- Or the HealthLink BC website at: www.healthlinkbc.ca/healthfiles/hfile33.stm
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