Schering-Plough has (to answer J&J's presser) put out a J&J arbitration status press release, overnight. Kenilworth also issued an overnight "Investor FAQs" (PDF file) document.
Because Schering-Plough has chosen to speak about these presumably material matters (see below), it would be fair to ask whether Schering-Plough's view is that there is nothing material to report about monthly IMS 'scrip data on the Cholesterol Franchise Joint Venture, Vytorin and Zetia. For thirteen consecutive months, ending in on January 20, 2009, Schering-Plough provided updates on these IMS monthly trends. It then said that it would stop doing so, as trends were "generally stabilizing". Schering-Plough's first quarter 2009 audited numbers told a different story, entirely -- down another 14.2 percent, in sequential quarters, in the US. What will Q2 hold? Who knows, at this point?
Okay -- from last night's FAQs, proper, then:
. . . .Q: Can you provide an update on patient enrollment for the Thrombin Receptor Antagonist (TRA) phase III program?
A: We have a global Phase III development program for TRA that includes two studies: TRA for Secondary Prevention (TRA•2P TIMI 50) and TRA for Clinical Events Reduction (TRA•CER). These trials are designed to show whether adding TRA to standard therapy will reduce cardiovascular events such as cardiovascular death, heart attacks, strokes and the need for urgent coronary revascularization. The TRA•2P study is being conducted by the TIMI group from Boston and TRA•CER is being conducted by the Duke Clinical Research Institute. There is a common Data Safety Monitoring Board (DSMB) for both studies.
Currently, there are more than 22,000 patients enrolled at over 1,000 sites in over 30 countries between both trials. The Executive Committee of the TRA•2P TIMI 50 trial recently increased the target sample size of the trial from 19,500 patients to approximately 25,000 patients based on blinded aggregated clinical event rates. . . . [Editor's Note -- Sounds a little like the ENHANCE events; and a little like what we may soon hear on IMPROVE-IT.] . . . .we do not expect the increase in patient enrollment in the TRA•2P TIMI 50 study to impact the estimated completion of the trial in September 2010. The estimated completion date is based on the accrual of the necessary number of patients with clinical events, as well as a minimum of one year patient follow-up. . . .Q: What is the status of the SAPHRIS (asenapine) regulatory application in the U.S.? When do you plan to file in Europe?
A: . . . .Schering-Plough has received a communication from the FDA that asenapine will be reviewed at an upcoming meeting of FDA’s Psychopharmacologic Drugs Advisory Committee (PDAC). A date for this meeting has not yet been disclosed. . . . [Editor's Note: Again, this portends a potential additional, newly-disclosed delay in the expected FDA approval date.]
More -- as ever -- to come.
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