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Biotech Stock Mailbag: Sarepta, Acadia, Vical and a Hep C Preview

Timothy A. asks, "What do you make of Vical delaying the Allovectin trial results again to the middle of 2013?"

It's ridiculous. The latest delay tells you the melanoma assumptions upon which Vical designed the phase III study are worthless. The study is a mess. If allovectin manages to demonstrate a survival benefit (miracles happen occasionally) it will be small and clinically meaningless. And while explaining to investors why they're waiting even longer for data, Vical management slips an ATM facility through the back door. Classy move, guys.

Gary B. emails, "What are your predictions for hepatitis C stocks at the meeting this weekend?"

I predict chaos and confusion. I long ago stopped expecting closure or certainty from these AASLD meetings. Hepatitis C drug development is too volatile.

Here's what to look for this weekend:

The AASLD media embargo lifts on Saturday at 9 a.m. Eastern time. Abbott (ABT - Get Report) and Gilead Sciences (GILD - Get Report) have told me that press releases with up-to-date data on their respective all-oral regimens will be issued at that time.

Abbott vs. Gilead is the main event at AASLD this year.

Abbott has set the efficacy bar high already with SVR12 "cure" rates of 96% to 99% in treatment-naive genotype 1 patients treated in its "AVIATOR" phase II study.

The Abbott drugs studied in AVIATOR were ABT-450, a protease inhibitor that requires blood-boosting with ritonavir; ABT-267, a NS5A inhibitor; and ABT-333, a "non-nuc" polymerase inhibitor. Ribavirin, a current backbone in hepatitis C treatment, was also included in some but not all of the combination regimens.

On Saturday, Abbott will announce updated results from the AVIATOR study.

Gilead will counter with SVR4 cure-rate data from the ELECTRON study involving a combination regimen of the nucleoside inhibitor GS-7977 and the NS5A inhibitor GS-5885, plus or minus ribavirin. ELECTRON also enrolls treatment-naive, genotype 1 hepatitis C patients.

Bristol-Myers Squibb (BMY) may shine on the undercard. Watch for SVR12 cure-rate data from the phase II combination of Bristol's NS5A inhibitor daclatasvir in combination with Gilead's GS-7997. While this combination isn't being moved into phase III, results will be viewed as a proxy for Gilead's '7977/'5885 combination.

On its own, Bristol will also be presenting data on a combination therapy involving daclatasvir, asunaprevir (a protease inhibitor) and the non-nuc BMS-791325.

I'm attending the AASLD meeting, which starts tomorrow and runs through Tuesday, so I'll have lots more to say about hepatitis C over the weekend and next week.

Mailbag updates:

Catalyst Pharmaceutical Partners (CPRX) announced the phase II failure of its cocaine addiction drug CPP-109 on Thursday. Treatment with CPP-109 for nine weeks failed to increase the number of addicts who were cocaine-free at the end of the study compared to placebo treatment. I wrote about Catalyst at the end of October.

MELA Sciences (MELA) turned in another subpart quarterly performance. Revenue from the sale of its MelaFind skin cancer detection device totaled just $69,000 in the September quarter. Cost of goods sold was a whopping $569,000, leaving MELA with a gross "profit" of negative $500,000.

Heckuva business model!

Throw in the rest of MELA's operating expenses and the net loss for the quarter was $5.4 million. MELA cash fell to $13 million.

MELA said it was still on track to meet guidance of 200 MelaFind system placements in the U.S. and another 75 in Germany by the end of March 2013. However, the definition of "system placements" has now been loosed to mean a signed user agreement only and not an actual installation.

MELA also acknowledged that dermatologists are using the MelaFind device more infrequently than initially projected.

All in, the Melafind launch is a bomb.

-- Reported by Adam Feuerstein in Boston.

Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.
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