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This Week in Biotech: Part 2

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With this week filled to the brim with clinical data and FDA panel rulings, I once again had to turn to two separate articles to properly summarize just what happened in the world of biotech stocks. In Part 1 of this week's review, I focused on the mountain of news in the hepatitis C sector this week. Now let's turn our attention to some other individualized stories that may have fallen through the cracks if you weren't paying close attention.

I wish I could say that I had nothing but great news to report about, but it was predominantly a week of disappointments.

Clovis Oncology (Nasdaq: CLVS  ) led the week off with a whimper as its metastatic pancreatic cancer drug, CO-101, proved to be a dud in clinical trials. The drug demonstrated no difference in overall survival when compared with Eli Lilly's (NYSE: LLY  ) Gemzar, the current standard of treatment. With both drugs boasting a survival rate of six months, Clovis decided to completely halt development of CO-101 and focus on its early-stage lung cancer treatment, CO-1686, which should have study data out in the first half of 2013. Shares of Clovis lost more than 40% on the news.

But just as one company's pain is another's gain, Celgene (Nasdaq: CELG  ) announced late last Friday that the combination therapy of Abraxane, with Eli Lilly's Gemzar, extended the overall survival of patients with metastatic pancreatic cancer over the use of just Gemzar alone. Although we don't have specifics survival rates yet, both Stifel Nicolaus analyst Joel Sendek and Citi Investment Research analyst Yaron Weber expect a roughly six- to eight-week boost in median survival rates. Abraxane was originally approved to treat breast cancer but has since gained the additional indication of treating non-small-cell lung cancer. With a well-known safety profile, Celgene may soon have another indication under its belt for Abraxane. 

Nektar Therapeutics (Nasdaq: NKTR  ) had a rough week, albeit nowhere near the same caliber as Clovis, following the Food and Drug Administration's recent cautionary stance on opioid-induced constipation drugs, or OICs. The company's late-stage OIC drug, Naloxegol, developed in collaboration with AstraZeneca (NYSE: AZN  ) , demonstrated no adverse cardiovascular or notable side effects during late-stage trials and met its primary endpoint. Investors seem hung up on the FDA's request for additional safety testing for Salix Pharmaceuticals (Nasdaq: SLXP  ) and Progenics' (Nasdaq: PGNX  ) OIC drug Relistor, but I think Mr. Market is getting riled up over what looks like nothing.  

Dynavax Technologies (Nasdaq: DVAX  ) joined the disaster du jour column this week after receiving a disappointing safety ruling from the FDA panel for its hepatitis B vaccine, Hepislav. By a vote of 13-1, the panel concluded that the drug worked to induce an immunogenic response in patients; however, by a vote of 8-5 it also noted that there wasn't enough data available to decipher whether the drug is safe. With safety data now overhanging Hepislav, an approval by its PDUFA date, Feb. 24, appears highly unlikely. 

Yet for all of Dynavax's woes, it was Tranzyme (Nasdaq: TZYM  ) that took home the crown of cliff diver this week, plunging 76% on Thursday alone. The impetus for the drop was the release of midstage data that showed its diabetic gastroparesis treatment TZP-102 failed to work better than the placebo for those patients taking two pills per day. An ongoing midstage trial where patients are taking the pill three times a day will continue. This marks the second time this year a leading drug candidate for Tranzyme has failed in clinical trials; ulimorelin, a drug designed to help patients recover their gastrointestinal function following surgery, failed in trials in March. Things are beginning to look bleak at Tranzyme.

Turn that frown upside down
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  • Report this Comment On November 19, 2012, at 11:08 AM, Hope4GoodFuture wrote:

    Thanks Sean. For Clovis, the issue was much worse than the fact that the drug didn't work. The larger issue was that the whole hypothesis for the drug- that low hENT1 expression equals worse survival with gemcitabine- turned out to be false. This trial showed that low hENT1 exressors did the same as high hENT1 expressors with gemcitabine, meaning that the whole basis for the trial was built on bunk. That, I believe, means that a whole lot of research, as well as reconfirmation of the research by a partner of Clovis, as well as review of the research by the Clovis team, was WRONG. Clovis has a lot of explaining to do. While patients in the trial probably got "the standard of treatment" with gemcitabine, they missed out on the Abraxane trial and the TH-302 trial, and others, that may have provided a far superior outcome for them. This company had the buzz of "good management". If investors are going to trust this company going forward, a highly transparent postmortem is needed asap to determine how they wasted so much on a false premise. I hope there is a very good explanation for what happened so we can move on and trust the basis for the next 2 drugs in the pipeline.

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