BOSTON (TheStreet) -- Let's roll with this week's Biotech Stock Mailbag.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%. Incivek was, and still is, a breakthrough for hepatitis C therapy because cure rates with interferon and ribavirin alone were only in the 40%-50% range and treatment lasted twice as long -- 48 weeks versus 24 weeks. Less than a year after Incivek's approval, the hepatitis C world has moved on to fixate on "all-oral" therapies -- combination of drugs that no longer require the bothersome weekly injections of interferon. That's what the EASL meeting is all about. Investors are insanely focused on two studies of Gilead Sciences' ( GILD) newly acquired hepatitis C drug GS-7977. Both studies enroll treatment-naive hepatitis C patients and treat them with a combination of '7977 and ribavirin.
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.)
Jim S. writes, "Adam, by the way, Celldex Therapeutics ( CLDX) put their CDX-011 breast cancer drug on clinical hold due to some issues at their supplier. They never issued a press release but stuck it in the 10-K. Kind of slimy." Eh -- not such a big deal. In January, FDA placed a partial clinical hold on Celldex's CDX-011 phase IIb breast cancer study because of manufacturing violations discovered during inspections at a third-party supplier of the drug. FDA told Celldex that no new patients could be treated with CDX-011, but patients already undergoing treatment could continue. Importantly, Celldex completed enrollment in the phase IIb study in December, so the partial clinical hold doesn't have a significant effect on the company's ability to complete the study and release results at the American Society of Clinical Oncology (ASCO) annual meeting in June, per its original schedule. We can argue about whether Celldex should have issued a press release about the CDX-011 clinical hold instead of just disclosing in its 10-K. As a journalist, I'm a "more disclosure is better" guy so I sympathize with the point made by Jim S. But this manufacturing problem seems like a relatively minor issue and has no bearing on the results of the CDX-011 study, which is the most material upcoming event for the company. A Celldex spokesman said no press release on the partial clinical hold was issued because the ability of the company to complete the study and analyze results were not hampered in any way. Celldex filed its 10-K containing the disclosure of the CDX-011 partial clinical hold on March 8, so it doesn't look like the stock was much affected. I've read some recent tweets from traders expressing concern about the fall in Celldex's stock price since late March.