Pharma’s Cutting Edge

For non-subscriber’s, here is the first paragraph of this story: “When the Food and Drug Administration surprised the company last week by withholding approval for the drug, Pargluva, saying it needed more information, many analysts assumed the delay would likely be no more than a year. But late yesterday, after the close of stock-market trading, Bristol-Myers said that the information that the FDA is seeking could take five years to obtain. As a result, the company said it will “consider a range of options including conducting additional studies or terminating further development” of Pargluva.”

Here is what I said about Pargluva on Pharma’s Cutting Edge October 19th: “…a Deutsche Bank analyst said he doesn’t think this approvable decision reflects on FDA’s current state of mind as regards risk mitigation. I disagree. I think that two years ago this drug would have met with approval accompanied by a rigorous postmarketing committment and surveillance program. Today it received an approvable with a likely approval hinging on further clinical trials before launch. I noted with skepticism commentary that approval could be delayed up to a year. In fact, approval could be delayed for much longer than a year depending on what is asked of BMS. If an outcomes study is required, forget it. That’s several years in the making at a minimum. However, if a surrogate study will suffice (and I can’t imagine which surrogate would be acceptable) a year is possible but unlikely.”

Okay, my point is not to toot my own horn. But, once again, you should view all public pronouncements of Wall Street analysts with skepticism. For the most part, they are spoon fed information from management, and beyond that, they have little knowledge of the industry and its inner workings and therefore little to say that is worth hearing. Also, what they say in public and what they tell their institutional clients are often two different things. Enough said on that topic. Please send all hate mail directly to the offices of PhRMA.

Another, even more important point, is the future of drug approval and of this class in particular. What happens to PPAR alpha/gamma dual agonists if BMS and Merck decide not to do the additional CV safety studies apparently required for approval? Are there any companies that will be willing to spend the additional money needed (I estimate the cost of an outcomes study as around $150 million out of pocket) to demonstrate CV safety pre-launch if BMS/Merck don’t pave the way first? You know what, I don’t think there are. Which companies will be affected if the entire class of dual PPAR agonists is forsaken? Here’s a list of some: Astrazeneca (tesaglitazar, Phase 3), Aventis (AVE-0847, Phase 1), Dr. Reddy’s (DRF-4382, Phase 1), Eisai (E-3030, Phase 1), Lilly/Ligand (naveglitazar, Phase 2), Novartis (LBM-642, Phase 1), Ono (ONO-5129, Phase 2), Plexxikon/Wyeth (PLX-204, Phase 1). Many others have not yet reached the clinical stage of development.