Monday, March 14, 2011

What HIV Drug Pipeline? Few New HIV Meds Approved In Last Seven Years

While Isentress® (raltegravir) has been a very successful cash cow for Whitehouse Station, it faces competition from at least 20 other high-end combination drugs in the post-modern HIV control marketplaces -- most of which need only be taken once a day. In this regard, recall that just this past Fall, Merck's "once a day" Isentress dosing study failed to show much benefit over existing therapies. Moreover, Merck really has nothing in line to follow it with, in short order. Gilead is poised to take the lead in the developed world here, from an industry-advantage perspective. [And so, the EU and US markets are seeing the beginning of pure price competitions -- per the graphic at right, from last summer -- click it to enlarge.]

More importantly, victims of the HIV visus face an increasing risk of strains that mutate to become resistant to all known treatment regimens. And the dry-spell -- in new practical new drug candidates -- is approaching a decade in length. That should motivate scientists to find new ways of attacking the mechanisms that drive the replication of the virus.

In any event, here is a bit of the Bloomberg story out over the weekend -- do go read it all:

. . . .Foster City, California-based Gilead and rivals Merck & Co. and Bristol-Myers Squibb Co. are victims of that success. Three decades after the discovery of the virus that causes AIDS, there are 31 drugs on the market that have helped turn HIV from a death sentence into a manageable disease in the developed world. Only six were approved after 2004.

“The bar for bringing on a drug in HIV has gotten higher,” said George Hanna, vice president of virology for U.S. medical and HIV early development at Bristol-Myers, based in New York. “You can no longer bring to market a drug you’re going to have to take three times a day. All of a sudden, we’re seeing a lot less in the pipeline.”

Medicines created over the years have become safer, more effective, have attacked the virus in new ways and have eliminated the need for as many as 20 pills a day. As drugmakers struggle to top that achievement, millions of HIV patients face the possibility of the virus becoming fatal again if it shifts shape inside cells to outsmart existing therapies. . . .

We'll keep you informed.

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