Replies to post #131005 on Biotech Values

[DewDiligence]

So [Vorapaxar] failed on both—lack of efficacy and increased bleeding.

Actually, failure on three out of four counts, including the TRACER and the TRA-2P studies (because the latter succeeded on efficacy):

http://finance.yahoo.com/news/Merck-Announces-Top-Line-bw-929800829.html?x=0

TRA-2P showed that the addition of vorapaxar to standard of care significantly reduced the risk of the protocol-specified primary endpoint of the composite of cardiovascular death (CVD), heart attack (myocardial infarction, or MI), stroke or urgent coronary revascularization compared to standard of care. There was a significant increase in bleeding, including intracranial hemorrhage (ICH), among patients taking vorapaxar in addition to standard of care, although there was a lower risk of ICH in patients without a history of stroke. The full results of TRA-2P will be presented at the American College of Cardiology Scientific Sessions in March.

… Merck will review the data from both TRA2-P and TRACER with the investigators and other outside experts to help better understand the profile of this investigational medicine in specific patient populations and to determine next steps, including potential regulatory filings.

Investors no longer expect anything at all from this drug; if by some miracle it makes it to market, it’s all upside.

[DewDiligence]

MRK seeks FDA approval for Vorapaxar (an antiplatelet drug developed by Schering-Plough) despite the checkered phase-3 dataset:

http://ih.advfn.com/p.php?pid=nmona&article=58529868

Merck…today announced that the New Drug Application (NDA) for its investigational anti-thrombotic medicine, vorapaxar, has been accepted for standard review by the U.S. Food and Drug Administration (FDA). Merck is seeking FDA approval of vorapaxar for the secondary prevention of cardiovascular events in patients with a history of heart attack and no history of stroke or transient ischemic attack.

As far as I know, MRK did not previously disclose the NDA submission (as is commonplace for Big Pharma).

Vorapaxar was once thought to have Plavix-like blockbuster potential, but intracranial hemorrhage in the phase-3 trials nixed that idea and led most investors to discount the drug’s commercial prospects entirely (#msg-58967119, #msg-71795997).

MRK is hoping to make an end run around the intracranial hemorrhage problem by proposing to restrict the label to patients with no prior stroke or TIA. Will the FDA go along with this? I don’t know, but any commercial contribution from Vorapaxar is all upside, for the reason mentioned above.