Short Course

FTC Breaks Out

Triangle Pharmaceuticals has announced the surprise early unblinding of their FTC-301 trial of Coviracil (FTC, emtricitabine), a nucleoside analog. The trial compared FTC head to head with d4T, both in combination with efavirenz and ddI. A data safety monitoring board took an early look at the data and decided to end the study due to superiority in one arm. The trial was unblinded, Coviracil crowned, and now all participants will be offered FTC.

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!

T-20 Expanded Access Limps Forward

In a conference call with community members, Roche Pharmaceuticals revealed their plans for wider release of T-20 through an expanded access program. So far, about 305 people are receiving the drug through a pilot safety study. Current plans (and there have been so many it wearies me to type this) call for greater drug availability on October 1. The company expects about 600 slots to open up in the U.S. with this new program. Although the hoops that doctors must shimmy through have been minimized, a hitch may come when providers learn they have to complete a full day's training on proper T-20 administration technique. Because T-20 is a fragile peptide that must be carefully reconstituted with sterile water before using (swirled not shaken!!), this training isn't a bad idea. Access won't be worth a hoot if patients fail to benefit from the drug because they never learned how to prepare and inject it properly.

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.