Its a March "spring forward" day here in Michigan, which is so much better then an October's "fall back" day. The good news is supposedly I saved an hour of daylight, the bad news is I'll never find it.
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GOOD news on Boceprevir and Telaprevir
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By Thomas Gryta Published March 14, 2011 Dow Jones Newswires
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NEW YORK -(Dow Jones)- A U.S. Food and Drug Administration panel will review two hepatitis C drugs in development from Vertex Pharmaceuticals Inc.
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(VRTX: 45.61, -0.85, -1.83%) and Merck & Co. Inc. (MRK: 32.28, -0.30, -0.91%) in late April, as the companies race to compete against each other in a potentially lucrative market.
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The agency's Antiviral Drugs Advisory Committee will review Merck's boceprevir on April 27 and Vertex's telaprevir on April 28. The widely expected reviews will have outside experts recommend whether the agency should allow the drugs on the market.
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Both drugs have shown success in increasing the cure rates of the liver disease when added to current treatments.They are expected to come to the market at similar times and be widely used, creating a market share battle. Merck said in early January that it was granted a six-month review; Vertex is getting a similar review and expects a decision by May 23.
Many on Wall Street believe that clinical trials show Vertex's telaprevir is the preferable drug, although Merck's Chief Executive Kenneth Frazier has repeatedly stated his confidence in boceprevir's prospects.Wells Fargo recently projected $1.4 billion in U.S. sales next year for telaprevir. Vertex owns the North American rights to the drug and would get a royalty on overseas sales from partner Johnson & Johnson (JNJ: 59.00, -0.69, -1.16%).
Hepatitis C is a blood-transmitted virus that causes liver inflammation and can lead to cirrhosis, cancer and liver failure.Both the Merck and Vertex drugs are known as protease inhibitors, which are designed to block an enzyme that helps the hepatitis C virus replicate. Standard treatment is a combination of the drug pegylated interferon and ribavirin, but adding the new drugs may improve cure rates and shorten the duration of treatment.
Copyright © 2011 Dow Jones Newswires
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Inovio Pharmaceuticals' partner ChronTech Pharma begins phase 2 trial for hepatitis C vaccine
by Deborah Sterescu
Inovio's partner ChronTech to begin phase 2b study for hepatitis C vaccine using Inovio's electroportation delivery system Vaccine developer Inovio Pharmaceuticals (AMEX: INO) said Monday that its partner, ChronTech Pharma, has begun a phase IIb clinical trial for a hepatitis C DNA vaccine delivered through Inovio's electroportation technology.
ChronTech's phase I study for the ChronVac-C DNA therapeutic vaccine, in combination with Inovio's delivery method, showed a "robust" increase in T-cell immune responses against hepatitis C, and was also safe and well-tolerated, Inovio said. T-cells belong to a group of white blood cells known as lymphocytes, and play a central role in the body's immune system.After the trial, patients were given standard-of-care treatment for the virus, and 70% of participants showed a complete and rapid viral response. Moreover, 83% of participants who were monitored for an extended period of time were free of the virus six months after they completed the standard-of-care treatment.“If we can repeat the Phase I results in this phase IIb study there is certainly a possibility that vaccination with ChronVac-C® before drug therapy could become a part of the standard of care therapy for patients with chronic hepatitis C-virus infection," said CEO of ChronTech, Anders Vahlne.
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The phase II study will follow on from the first trial, further exploring the effects of the vaccine in 32 patients. The combination therapy will be administered two times in 20 patients, while the 12 patient comparison group will receive standard-of-care treatment alone.DNA vaccines are designed to generate broader, cross-protective immune responses across different virus strains, unlike existing vaccines that must be matched to a specific serotype. When used to deliver DNA vaccines, Inovio's electroportation systems can increase levels of immune responses by 100 times or more compared to DNA delivered without other delivery enhancements.
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Hepatitis C treatment breakthrough
Kate Hagan
March 15, 2011
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A NEW treatment for hepatitis C trialled in patients at The Alfred hospital has cut debilitating side effects and reduced treatment times, creating the potential for many more patients to be cured of the disease. About 250,000 Australians have hepatitis C but only 5 per cent choose to have the current treatment due to multiple side-effects such as psychotic episodes, depression, insomnia and muscle aches and pains. Current treatment involves weekly injections of interferon - a protein that fights the virus but causes the side effects - as well as twice-daily tablets for up to seven weeks.But researchers have found that a combination drug without interferon is even more effective, curing some patients of the disease within two weeks in a recent trial...
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For Non- U.S. Media only
New Hepatitis C Data from Boehringer Ingelheim HCV Portfolio to Be Presented at EASL
New data from the Boehringer Ingelheim hepatitis C virus (HCV) portfolio will be presented in oral scientific sessions at the International Liver CongressTM 2011, the 46th Annual Meeting of the European Association for the Study of the Liver (EASL), taking place 30 March-3 April in Berlin, Germany.
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The data will include final results from SILEN-C1 and SILEN-C2, two Phase IIb studies evaluating one of Boehringer Ingelheim’s investigational compounds for Hepatitis C treatment, the once-daily, oral protease inhibitor BI 201335 in combination with the current standard-of-care (pegylated-interferon and ribavirin).
Oral presentations (Friday, 1 April, 2011; Parallel Session: HCV Drug Development, Hall 1)SILEN-C1: Sustained Virologic Response (SVR) and safety of BI201335 combined with peginterferon alfa-2a and ribavirin (P/R) in treatment-naïve patients with chronic genotype 1 HCV infection(Abstract 60. M. Sulkowski, et al. 16:00h - 16:15h)
SILEN-C2: Sustained Virologic Response (SVR) and safety of BI201335 combined with peginterferon alfa-2a and ribavirin (P/R) in chronic HCV genotype-1 patients with non-response to P/R(Abstract 66. M. Sulkowski, et al. 17:30h - 17:45h)
Boehringer Ingelheim is continuing its long heritage in virology and is dedicated to developing new medicines to improve treatment for HCV patients. BI 201335 is part of a growing HCV portfolio that is being investigated with the aim of identifying a simpler HCV cure, overcoming the challenges of current treatments.Additional HCV studies to be presented at EASL
SVR and Pharmacokinetics of the HCV protease inhibitor BI201335 with PegIFN/RBV in HCV genotype-1 patients with compensated liver cirrhosis and non-response to previous PegIFN/RBV(Poster 1231. S. Pol, et al.; Saturday, 2 April, 2011, 09:00h - 18:00h)
Mechanisms of isolated unconjugated hyperbilirubinemia induced by the HCV NS3/4A protease inhibitor BI201335 (Poster 1236. R. Sane, et al.;Saturday, 2 April, 2011, 09:00h - 18:00h)
BI201335 Pharmacokinetics and early effect on viral load in HCV genotype-1 patients(Poster 1249. C. Yong, et al.;Saturday, April 2, 2011, 09:00h - 18:00h)
Preclinical Characterization of the hepatitis C virus NS5B polymerase non-nucleoside inhibitor BILB 1941 (Poster 1215. G. Kukolj et. al.; Friday, 30 March, 2011, 09:00h - 18:00h)
The abstracts can be accessed through the EASL website, http://www.easl.eu/.
For more information on BI’s hepatitis portfolio,please visit http://www.boehringer-ingelheim.com/
and follow us on Twitter. www.twitter.com/boehringer.
Read more: http://www.montrealgazette.com/
Clinical Care has a new set of slides ready to download.
Slideset: Future Generations: Understanding the Similarities and Differences Among Direct-Acting Antivirals for Hepatitis CStefan Zeuzem, MD, reviews the characteristics of directly acting antivirals currently in development and discusses the role these agents may have in future combination regimens for HCV.
Format: Microsoft PowerPoint (.ppt) File size: 2.52 MB Date posted: 3/1/2011
Free registration required
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Consortium Finds Chronic Liver Cirrhosis Clues
14 March 2011Researchers have provided new clues into the genetics underlying a chronic form of liver disease, called primary biliary cirrhosis, which can lead to transplant surgery for patients...
14 March 2011Researchers have provided new clues into the genetics underlying a chronic form of liver disease, called primary biliary cirrhosis, which can lead to transplant surgery for patients...
Conatus Pharmaceuticals Will Display HCV Clinical Trial Data At The International Liver Congress™ (EASL) In March
12 March 2011Conatus Pharmaceuticals Inc. announced the acceptance of two poster presentations of Phase 2 clinical trial data of CTS-1027 for the treatment of hepatitis C virus-infected patients at the 46th annual meeting of the European...
Fat Accumulation In The Liver Leads To Disease But Certain Molecules Offer Protection
12 March 2011The liver normally makes and stores fat, which is required in moderation for normal body function. However, if the process goes awry, excess fat in the liver can cause major liver damage...
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SUMMARY: HIV positive gay and bisexual men in the log-running Multicenter AIDS Cohort Study (MACS) were significantly more likely to die of liver-related causes than HIV negative participants, and those coinfected with hepatitis B virus (HBV) had about double the risk of death than those with hepatitis C virus (HCV) coinfection, according to a poster presented at the 18th Conference on Retroviruses and Opportunistic Infection (CROI 2011) last week in Boston.
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Patients Sue New Orleans Hospital Over Endoscope Reprocessing Glitch
Tulane Medical Center admits scopes weren't properly sanitized, but says infection risks are remote.
A married couple has sued Tulane Medical Center over its use of improperly sanitized endoscopes, which they claim potentially exposed patients to HIV and hepatitis B and C. The New Orleans facility acknowledges that a breach in reprocessing protocol occurred, but claims infection risks to patients are "minimal to non-existent."
Tulane Medical Center admits scopes weren't properly sanitized, but says infection risks are remote.
A married couple has sued Tulane Medical Center over its use of improperly sanitized endoscopes, which they claim potentially exposed patients to HIV and hepatitis B and C. The New Orleans facility acknowledges that a breach in reprocessing protocol occurred, but claims infection risks to patients are "minimal to non-existent."
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Related On The Blog ;Mar 14th A Hard Look At The Transmission Of Hepatitis C
Today this blog takes a closer look at the transmission of Hepatitis C, using statistics/data from medical journals, and credible online sources including Reuters and Associated Press.
This information will also include the recent rise in HCV transmissions through dental and or medical procedures.
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The recent cases of HCV infections transmitted via a clinical setting have caused the public to question their own safety in regard to the transmission of all bloodborne pathogens while undergoing future medical procedures.......
This information will also include the recent rise in HCV transmissions through dental and or medical procedures.
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The recent cases of HCV infections transmitted via a clinical setting have caused the public to question their own safety in regard to the transmission of all bloodborne pathogens while undergoing future medical procedures.......
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ALBANY, Ga. — After four years of trying to sell its Albany plant, Merck & Co. officials say they will demolish the facilities on Radium Springs Road, restoring it to the green space it was prior to the plant’s construction nearly 60 years ago.
But state and federal officials say that Merck’s challenge to restore the land where it was before it started production in 1952 will continue long after the walls come down, as investigations and environmental cleanup efforts continue on the 1,000-acre site in southern Dougherty County.
Following inquiries by The Albany Herald, the Federal Environmental Protection Agency (EPA) and the state’s Environmental Protection Division of the Department of Natural Resources (EPD) have released information relating to the Merck facility site at 3517 Radium Springs Road.
According to those two agencies and Merck officials, the former chemical manufacturer is currently remediating contaminated soil and groundwater on the Merck site that was exposed to various chemicals over the company’s history......
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But state and federal officials say that Merck’s challenge to restore the land where it was before it started production in 1952 will continue long after the walls come down, as investigations and environmental cleanup efforts continue on the 1,000-acre site in southern Dougherty County.
Following inquiries by The Albany Herald, the Federal Environmental Protection Agency (EPA) and the state’s Environmental Protection Division of the Department of Natural Resources (EPD) have released information relating to the Merck facility site at 3517 Radium Springs Road.
According to those two agencies and Merck officials, the former chemical manufacturer is currently remediating contaminated soil and groundwater on the Merck site that was exposed to various chemicals over the company’s history......
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News From The Investment Guys
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Seeking Alpha
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The recent hoopla surrounding Pharmasset (VRUS), as well as the excitement regarding two NDAs for hepatitis C, made me take a closer look at this disease and what is coming down the pipeline.
Hepatitis C virus (HCV), along with alcoholism, is one of the most important causes of chronic liver disease in the United States. Sixty to 70 percent of chronic hepatitis, and up to 50 percent of cirrhosis, end-stage liver disease, and liver cancer are caused by the virus. It is estimated that 4.1 million Americans have antibody to HCV (anti-HCV), and 1.2 million have active disease. Approximately three quarters of those infected develop chronic infection. The disease is responsible for about 10,000 deaths a year in the US alone. More details can be found at the NIH NIDDK website.
Hepatitis C virus (HCV), along with alcoholism, is one of the most important causes of chronic liver disease in the United States. Sixty to 70 percent of chronic hepatitis, and up to 50 percent of cirrhosis, end-stage liver disease, and liver cancer are caused by the virus. It is estimated that 4.1 million Americans have antibody to HCV (anti-HCV), and 1.2 million have active disease. Approximately three quarters of those infected develop chronic infection. The disease is responsible for about 10,000 deaths a year in the US alone. More details can be found at the NIH NIDDK website.
The present standard of care is a combination therapy of interferon alpha and ribavirin for 24 – 48 weeks. Approximately 55% of subjects (combined virus types 1, 2, and 3) respond to 48 weeks of therapy. Virus types 2 and 3 have response rates of 70 – 80%, whereas type 1 has a response rate around 40%. Doses required for type I are higher (1000 - 1200 mg of ribavirin a day) compared with types 2 and 3 (800 mg a day). Responders are measured as rapid virus response (RVR - where the virus is undetectable after 4 weeks of treatment) and sustained virus response (SVR - where the virus is undetectable 24 weeks after therapy). Complicating the picture is the presence of cirrhosis, co-infection with HIV, etc. But in general, patients with viral load of 400,000 IU/ml or lower respond better.
Therapy is also complicated by the side effect profile of both drugs. Interferon causes depression, exacerbation of auto-immune diseases and bone marrow suppression. Ribavirin causes red cell hemolysis and so cannot be used in those with coronary artery disease, strokes, or renal dysfunction. It also releases histamine, resulting in symptoms akin to allergic rhinitis and asthma. This side effect profile is important as we shall see in a moment.
It is clear that Hepatitis C is an important disease, and a lucrative opportunity for the pharmaceutical industry. Therefore it is no surprise that clinicaltrials.gov has more than 360 trials listed, and more than 20 drugs are in development. Of these, the first two out of the gate have been from Merck (
MERCK: Merck filed an NDA for boceprevir earlier this year. The filing was based on phase III studies - RESPOND2 study was in subjects who had failed prior therapy, whereas SPRINT2 study was in treatment naïve subjects. Boceprevir was added to the background of interferon and ribavirin, and approximately 65% of subjects responded as measured by SVR. Placebo response rate was in the 25% - 35% range. Anemia was reported in approximately twice the number of subjects who received boceprevir compared with placebo, and was managed by administration of erythopoeisis stimulating agents (such as EPO, etc. Keep in mind that ribavirin also causes anemia. The FDA has granted Merck six month priority review.
VERTEX: Shortly after Merck, Vertex filed an NDA for telaprevir. The filing was based on three studies – ADVANCE, ILLUMINATE, and ADVANCE. Telaprevir was added to the background of interferon and ribavirin, and approximately 75% of subjects responded as measured by SVR, compared with 45% on placebo. Vertex showed that the time required to treat was also half that of the conventional 48 weeks. Another differentiating feature is that telaprevir was shown to be effective in those with high viral load (800,000 IU/ml) and with cirrhosis. From a side effect profile, rash and anemia were more common in the telaprevir cohort than the placebo cohort, and anemia was managed by reducing the dose of ribavirin rather than by administrating erythopoeisis stimulating agents (such as EPO, etc), but I could not find the exact numbers from the Vertex website. The FDA has granted Vertex six month priority review
Assuming that both drugs get approved by the middle of this year, it will pose a challenge to further drug development of other candidates. If one or both of these drugs become the standard of care, it will make it harder to conduct a placebo study like the one conducted by Merck and Vertex. The way around that is by new combinations that don’t use interferon as background therapy. Another issue is if the drugs prove to be as effective in clinical practice as in the trials, it will also make it harder to find patients to participate in the trials, at least in the US. With that in mind, here are some other companies that have drugs in the pipeline (based on clinicaltrials.gov, accessed on March 13, 2011) – this is not an exhaustive list by any means.
Company........Compound........Phase.....Genotype
Janssen..............TMC435........III............I
Boehringer......B1201335..........III............I
BMS ..................IL-29..............II............?
Vertex ....VX222 + telaprevir.....II............I
Pfizer .............Filibuvir.............II............I
BMS .......790052 + 650032...,...II...........I
Novartis .....DEB025............II.............2, 3
Gilead .....9190/9256...........II.................I
Gilead......9190/9541...........II.................I
Hoffman.......05303253........I..................I
Merck...........7009...............I..................I
Okairos....AdCh3NSmut.......I..................I
Okairos....Ad6NSmut...........I..................I
Merck..........5172.................I..................?
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So, what about Pharmasset?
While the data that caused the stock to rocket has not been published, rumor has it that the combination of PSI-938 and PSI-7977 “eliminated the virus” (such a short duration does not even come under RVR) in 15 out of 16 subjects in a matter of 14 days. Just keep in perspective that the primary endpoint for approval is SVR. And that 14 days is too short a time for the virus to become resistant to drugs. Similar efficacy has been seen at such early stage with other combinations as well. Now if that efficacy holds in SVR after 24 weeks of therapy, it will be a totally different story.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
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Off The Cuff
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The problems posed by counterfeit meds are not new, but 60 Minutes last night offered its own take on the situation, including a raid in Lima, Peru, where police visited an outdoor market and then a shoddy little factory at a nearby home. Then there is a visit to a lab in the US that examines a bottle of the Zyprexa antipsychotic with a phony label. You can watch the action along with select portions of the program and also read comments from FDA commish Margaret Hamburg here.
Across the pond, meanwhile, the UK’s Medicines
Across the pond, meanwhile, the UK’s Medicines
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Healthy You
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29 minutes ago
A late-stage trial of a monoclonal antibody for type 1 diabetes failed to meet its primary endpoint of preserving beta cell function, researchers said.
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The Weekend Updates On The Blog;
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