Notes on HIV Drugs in Development
Triangle says it is currently preparing to submit its FTC licensing package to the FDA in September. If the agency decides to expedite approval, a decision could be reached within six month.
In a simultaneous news release, Triangle announced that they have severed their marketing relationship with Abbott Pharmaceuticals. Under the agreement, Abbott would have brought FTC to market through a well-established sales force already servicing Kaletra. The companies claim this parting of the ways was due to a divergence of interests, with Abbott now pursuing protease inhibitors and hepatitis C treatments, and Triangle going for nukes and hepatitis B drugs. Triangle currently has no sales apparatus, so it remains to be seen if they try to go it alone or cut a deal with another pharma giant.
FTC has a very forgiving, long half-life and should make a practical once-a-day drug. One radical marketing strategy might be for Triangle to license FTC for co-formulation into a fixed dose combination with a compatible drug such as efavirenz or tenofovir. Radical!
The company has promised to review all of their enrollment procedures once again and cut the fat. That said, no one who has followed this enduring saga of gaining access to T-20 will be surprised if the debut is slow and sludgy. Roche expects to go to the FDA with their bid for approval before year's end. This one will surely be fast tracked, and it may be a horse race to see who gets the drug first: the expanded access enrollees or your neighborhood pharmacy.
This article was provided by Gay Men's Health Crisis. It is a part of the publication GMHC Treatment Issues. Visit GMHC's website to find out more about their activities, publications and services.