Pharmas Market with Mike Huckman

Daughter of Vioxx


Since another pharmaceutical industry blog has already posted an item about this under the title, "Son of Vioxx...." and since I don't want to be accused of plagiarism or sexism I've opted for "Daughter of Vioxx".

Tomorrow (Wednesday) we'll be airing a story beginning on "Squawk Box" at around 7:10 a.m. ET about Merck's hoped-for successor to Vioxx called Arcoxia. As fate would have it, Merck uber-Director, Larry Bossidy, is guest-hosting "Squawk" tomorrow, so we'll be able to chat with him about the drug as well.

Arcoxia is a COX-2 inhibitor. In other words, it's in the same class of drugs and uses essentially the same mechanism of action as Vioxx, Bextra and Celebrex. Of those three only Celebrex is still on the U.S. market. Pfizer sold more than $2 billion worth of Celebrex last year and just last week started running TV commercials for the drug after a more than two-year self-imposed (and FDA-encouraged) hiatus. Merck goes before one of those FDA Advisory Committees regarding Arcoxia this Thursday. The company already sells the drug in 63 countries where it rang up more than a quarter-billion dollars in revenues last year (not huge by pharma standards). The company has also tested Arcoxia on more than 45,000 people and claims--without getting too deep into the science--that it is an effective alternative for the millions of osteoarthritis patients who aren't getting relief with currently available drugs, has no greater risk of heart attack or stroke than an older, little-used (in the U.S.) drug, has a manageable high-blood-pressure side effect, and is gentler on the tummy. Critics ranging from Dr. Steven Nissen of The Cleveland Clinic to Dr. Sidney Wolfe of the consumer-advocate group Public Citizen say Arcoxia is unsafe and shouldn't get to the American market. The committee will decide whether to recommend the FDA approve or reject the drug. But even if it passes muster - most, if not all Wall Street analysts think Arcoxia would get the most severe "Black Box" or FDA safety warning and therefore would scare patients and doctors away. I've read several analyst research reports and they have either no or very small future revenues ever coming into Merck from U.S. sales of Arcoxia.

Watching the proceedings closely will be Novartis which expects the FDA to decide whether to approve its COX-2 drug Prexige by the end of this year. And, of course, Pfizer which is hoping to keep the corner on the U.S. COX-2 market.

Questions?  Comments?