HCV News Extravaganza
Sep08

HCV News Extravaganza

Apparently everybody in the hepatitis C race was busy over the holiday weekend, as Tuesday brought a flood of news from the sector. There was good news, bad news, and an acquisition. Last things first: the acquisition. Bristol-Myers Squibb announced it will fork over $885 million for Zymogenetics, its partner in the development of pegylated interferon-lambda, in Phase II trials to treat hepatitis C (HCV). If you’ll recall, last year BMS paid $85 million upfront and a $20 million licensing fee for access to the drug. Under that arrangement, the Seattle-based biotech would have scored up to $430 million in milestones if the therapy actually made it to patients. Given Zymogenetics product pipeline and its one marketed product, Recothrom, the $885 million price tag doesn’t sound so outlandish. Interferon-lambda uses the same cell-signaling pathway as interferon-alfa, one of the two cornerstones of current HCV therapy. But as we wrote earlier this year, because interferon-lambda has fewer functions in the body than interferon-alfa, it is expected to be as effective with milder side effects. Onto the bad news: Idenix Pharmaceuticals said FDA put a clinical hold on two of its hepatitis C drugs, IDX184 and IDX320, due to liver toxicities in a small trial testing the safety of giving both drugs to healthy people. The company’s stock took a beating on the news, with shares falling by 47% to close at $3.18 yesterday. The question now is which of the molecules is causing the elevated liver enzymes. Leerink Swann analyst Howard Liang commented on the issue in a note to investors this morning: “The lack of association between the liver toxicity signals and IDX184 exposure and more extensive safety data on IDX184 would suggest us to that IDX320 is more likely the culprit than IDX184, which is the more important asset in our view." And the good news (part 1): Vertex Pharmaceuticals released more positive Phase III data for telaprevir, its much-anticipated protease inhibitor for HCV. The drug candidate was tested in some of the toughest patients—those who didn’t respond to or had only a partial response to the standard of care (pegylated interferon and ribavirin) or whose disease relapsed after standard of care. Vertex said 65% of those HCV patients were “cured” when adding telaprevir to the treatment regimen, compared to 17% in the control arm, which was given just the standard of care. Take a look at the company’s press release for more details on each segment of patients, but the relapsers had the most success with treatment, with a smaller portion (31%) of the folks that didn’t respond at all to interferon and ribavirin seeing complete suppression of...

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Drug Candidates to Watch (or not)
Jun03

Drug Candidates to Watch (or not)

Thompson Reuters has come out with a review of what it considers the most promising drug candidates in clinical trials. Although definitions of "promising" may differ (projected sales? impact on patients? innovative approach?) the research firm thinks that cancer drugs and therapeutics that address small patient populations--so called "orphan" indications--are particularly interesting. We’ll leave you to take a look at the Phase III and launched drug lists yourselves, and instead peruse the research firm's choices for the most intriguing treatments in early-stage studies. Without further ado, here’s what they’re keeping an eye on from the Phase II category: 1. ALKS-33: an alcohol addiction treatment from Alkermes 2. Recombinant PEG-interferon lambda-1: Hepatitis C treatment being co-developed by ZymoGenetics and Bristol-Myers Squibb. 3. PHA-848125: small molecule for the treatment of thymic cancer by Nerviano Medical Sciences 4. PCI-27483: a small molecule for the treatment of pancreatic cancer by Pharmacyclics 5. SBI-087: an antibody treatment for rheumatoid arthritis that Pfizer inherited from Wyeth, which in turn had licensed from Trubion Pharmaceuticals Some thoughts on their Phase II list. First, unsurprisingly, two out of the five picks are oncology drugs. Second, chemistry isn’t dead: three out of the five candidates are small molecules. Last, both of the biologics are quasi-next-generation versions of existing drugs. BMS and Zymogenics’ pegylated lambda-interferon is an alternative to pegylated alpha-interferon (see our coverage of the alternative interferon space here), while SBI-087 is going after CD-20, the same target as Biogen Idec and Genentech’s Rituxan. I’m perplexed at how one winnows out what the most promising Phase I candidates are, but of note is that there’s only one small molecule and one cancer drug candidate on this list. Here’s what Thompson Reuters is giving a shout out to from the earlier reaches of the pipeline: 1. Ad4-H5-Vtn: an avian flu virus vaccine by PaxVax 2. Adoptive T-cell therapy: an HIV treatment by Adaptimmune 3. BI-505: antibody to treat multiple myeloma by BioInvent 4. CHF-5074: a small molecule to treat Alzheimer’s disease by Chiesi 5. sFLT-01: gene therapy for wet age-related macular degeneration by Genzyme and Applied Genetic Technologies I will quibble with the choice of Chiesi’s Alzheimer’s drug, which combines a flurbiprofen analog (an anti-inflammatory agent) and a gamma-secretase inhibitor. Several big pharma firms have been working for years on molecules to block gamma-secretase, an enzyme that enables the formation of beta-amyloid, the main component of the plaque gumming up the brains of Alzheimer’s patients. Many of those compounds are already in late-stage trials, including one by Bristol-Myers Squibb that is exquisitely selective and potent. I’d be more impressed if Chiesi had a compound that blocks beta-secretase (the other...

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