Wednesday, April 08, 2009

Novartis is FDA's First Priority

First priority review voucher recipient for gaining approval of a tropical disease therapy, that is.

We told you about the FDA incentive last July, when The RPM Report published an analysis of the new voucher program. (Non-subscribers can click here for a free trial, Mike McCaughan's bloggy version is here.) Well today Novartis received approval for its Coartem combination malaria therapy, and became the program's first beneficiary.

But what's Novartis going to do with its prize? Despite the funny-money image above, a priority review voucher could be worth some serious cash to a pharmaceutical company--perhaps even much more than Novartis could get by actually selling Coartem to travelers to malaria hotspots. That is it would be, if anyone actually knew how to use one.

As we reported in The Pink Sheet back in February, Big Pharma has shown plenty of interest in the program, but it still has plenty of questions as well. Quoth the 'Sheet:

Pfizer, Merck and Sanofi-Aventis each submitted comments on the October draft guidance, which explains how the agency intends to implement a program that rewards sponsors of a drug to treat a neglected disease with a voucher to obtain a faster review of another application.

The comments raise several questions about implementation of the program and especially about the mechanics of redeeming the vouchers.

Stay tuned. The fate of this first voucher may go a long way toward predicting the potential utility--and value--of the program as a whole. And who knows, if Novartis gets a good deal for its voucher, maybe FDA's incentive scheme will generate the desired effect: new drugs for tropical diseases.

1 comment:

Anonymous said...

nice going ramsey bigdaddy with your drug withdrawal prediction. Goodbye Raptiva (only 2,000 users in the U.S). According to Ramsey, this drug was forced off the market by FDA to show industry that "it is not business as usual" now that new leadership is on board. I guess it didn't matter that several patients died with PML... FDA had to make a point. (what rubbish are you going to write next?)