This morning we learned that the FDA has issued another "approvable" letterto Pozen and GlaxoSmithKline for their migraine drug Treximaover safety concerns.
POZN shares are down big. The company has scheduled a conference call for 11 a.m. ET. This is the third regulatory stumbling block for this drug and puts it on a timeline now where it could end up competing with a Merck drug that many analysts and medical experts believe looks much better than Trexima.
It also represents a challenge for Glaxo because its migraine drug Imitrex could go generic as early as next year. However, a Pozen spokesperson says the issues raised by the FDA about Trexima could be addressed in a short amount of time. Expect to hear details on the conference call. The announcement in the delay of the Trexima approval comes the morning after an interesting Op-Ed piece appeared in "The Wall Street Journal" regarding the FDA drug approval process.
Dr. Richard Miller, a co-founder of Idec, the CEO of Pharmacyclics and an adjunct professor of oncology at Stanford, wrote the item which appeared under the headline, "Cancer Regression". (subscription required to read full article).
Dr. Miller specifically mentions what has happened recently with Dendreon's Provenge and satraplatin from Pharmion (up big on separate positive news today) GPC Biotech and Spectrum Pharmaceuticals . Both of those drugs are for prostate cancer.
Dr. Miller wrote:
"Sadly, the message that the Food and Drug Administration is delivering to cancer patients is that the "fight against" tumors is regressing. Satraplatin is the "fifth" promising cancer treatment set back by the FDA this year."
He calls Provenge "revolutionary" and claims that in delaying the approval of these cancer drugs that "the FDA overlooked substantial evidence of the drug's positive impact...that should have been at least sufficient to warrant conditional approvals under established regulations that have been eroded by the Agency's bureaucratic intransigence."
He concludes by urging Congress to intervene and "require the FDA to follow the existing regulations on accelerated (drug) approval." That's essentially what Provenge proponents, in particular, have been asking for since the FDA delayed approval of that drug last May.
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