Hello, everyone, and top of the morning to you. A steely, wintry sky hovers over the Pharmalot corporate campus this morning, where we are enduring the usual routine of hustling short people to this or that school house. As we cope - where is that cup of stimulation? - please join us in perusing the news of the world. Meanwhile, feel free to pass along interesting tidbits. Have a good one...
AstraZeneca And Cancer Charity Strike Drug Testing Deal (Bloomberg News)
FDA Warns Of Acetaminophen Risks Of Liver Toxicity (Drug Store News)
Drug Shortages Persist With No End In Sight (Daily Finance)
Biotechs And Generics Spar Over Biologic Exclusivity (The Wall Street Journal)
FDA Says Sanofi-Aventis' Lantus Link To Cancer Is Unclear (Reuters)
US Cancer Costs Are Expected To Soar (Los Angeles Times)
FDA Panel Rejects Eli Lilly Pancreas Drug (Associated Press)
Genzyme Lowers Guidance After Fabrazyme Delay (InPharma-Technologist)
KV Faces Another Setback After FDA Delays Drug Review (St. Louis Post-Dispatch)
FDA Reviews An Electronic Drug Patch (EE Times)
Valeant Proceeds With Planned Layoffs (Canadian Press)
2 Comments
Merck had some disappointing news today -- on Vorapaxar -- see here. MRK is off over $2 on the NYSE, due to a stop in a Phase III study of the drug, by the safety review panel.
Here is the Merck webcast/call live-blog -- quick-typed by yours truly:
LIVE-BLOG:
Q: Tim Anderson (Sanford Bernstein) -- "Was bleeding the issue?; sure sounds like it. . ."
A: Peter Kim -- That was not stated by the DSMB (reviewing safety panel).
Q: David Reisinger (Morgan Stanley) "Timing?"
A: Peter Kim -- That is not yet known. . .
Q: Barbara Ryan (B of A) -- Was futility the issue? What do you think?
A: Peter Kim -- That is unknown.
Q: Catherine Arnold (Credit Suisse): How was the study powered; is this ambiguous?
A: Peter Kim -- These studies are highly powered, but we need to evaluate our data -- we will have a future disclosure.
Q: Seamus Fernandez (Leerink Swann) -- "Wasn't this a safety study, primarily? So, what was the value proposition?"
A: Peter Kim -- We don't have a view as to why (other than what we have stated).
Q: [Name?] Cowen & Co. -- "Was it stopped for overwhelming efficacy?"
A: Peter Kim -- We don't have a view as to why (other than what we have stated).
[Call ended at 10:22 AM EST.]
For what it's worth, it would be nearly impossible to imagine a discontinuation in one study -- and the instruction not to medicate prior stroke victims -- if it was safe and effective. The DMSB would likely only act if patient safety were in issue -- and that clearly seems to be the case with prior stroke sufferers.
This is unfortunate in the extreme -- as the Vorapaxar program was a bright hope for many cardiac patients -- let us hope that the data is not as bad as the DMSB has assumed.
Remember, the DMSB is charged first with "do no harm" -- so it might have erred on the side of protecting stroke patients. I admit that seems unlikely, as well -- to my experienced eye.
Namaste
Link to article "KV Faces Another Setback..." seems to be broken.