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TheStreet Open House

Biotech Stock Mailbag: All You Need to Know About Hep C Drugs

This study is important for several reasons. It's the first time we'll see "cure rate" data from a combination of these two types of drugs. Daclatasvir is an NS5a inhibitor; '7977 is a nucleoside polymerase inhibitor.

If the results are impressive, Bristol-Myers could conceivably move ahead quickly with the development of its own all-oral regimen -- combining daclatasvir witih INX-189, the nucleoside polymerase inhibitor acquired through the purchase of Inhibitex.

Likewise, Gilead could move forward with a combination of '7977 and its own internal NS5a inhibitor GS-5885.

As above, ISI Group's Schoenebaum asked his Wall Street investor clients to forecast the results from the daclatasvir-'7977 study. Expectations: An SVR4 rate of 77%.

EASL is a busy meeting so while I highlight these three studies as the most important for investors, I don't mean to short-change data expected from Abbott (ABT), Johnson & Johnson (JNJ), Idenix Pharmaceuticals (IDIX) and Vertex Pharmaceuticals (VRTX), among others. I'll be covering the conference as will health-care investor and TheStreet contributor Nathan Sadeghi-Nejad. In fact, he'll be in Barcelona attending the conference.


Roger J. emails a question about my FDA Drug Approval Contest: "I have heard that an investor who bets against approval on any new drug is likely to be successful. Hence it would be helpful to know how many yes/no votes the referenced contestants cast to compile their records, and what record I would have had by voting no on every drug in the contest."

I don't understand the first part of the question but to address the latter: Seven drugs featured in the contest have received FDA approval; five have been rejected and a single decision ( Vivus' (VVUS) Qnexa) has been delayed.

Simply betting "no" across the board is not a winning strategy. I'm all for skepticism when warranted, but FDA does approve drugs.


BuggyFunBuggy (a frequent commenter) asks, "Perhaps a Mailbag update on Agenus (AGEN). It's been a while since your prediction that "Oncophage doesn't work," and it seems that Prophage is just a new name. Has Agenus any brighter future?"

Agenus' cancer vaccine platform is old news. The Russian approval of the Oncophage for kidney cancer yielded meaningless sales and I haven't heard a peep from Agenus executives about trying to seek approval in Europe or the U.S. (Failed clinical trials have a way of making approvals a tad more challenging.)

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