Project Inform cited in the press

 

FDA OKs New HIV Drug

By Bob Roehr, Bay Area Reporter, June 28, 2006
www.ebar.com
(mention of Project Inform in bold below)

The Food and Drug Administration approved the sale of Prezista (darunavir), on June 23, as part of combination therapy in treatment-experienced adults with HIV. The resistance profile to the protease inhibitor differs significantly from most other drugs in that class and so it is particularly useful for patients who have run out of other options.

Prezista previously was known as TMC114. It is the first drug developed by Tibotec, now a division of Johnson & Johnson. It is taken twice a day with a low dose of ritonavir, as are most other protease inhibitors, which retards clearance by the liver.

"Based on the evidence we've seen so far, this is very likely the most successful drug yet for treating people with high levels of resistance," said Paul Dalton of San Francisco-based Project Inform.

Equally significant is the pricing. Tibotec, under strong lobbying pressure from community organizations, broke with past industry practice of pricing a new drug at the top of that class.

"We're elated they have taken our suggestion and reversed the upward spiral of unconscionable new life-saving drug prices," said Lynda Dee with the AIDS Treatment Activist Coalition. "While ATAC would prefer even lower drug prices, we believe this represents real progress."

"This is the first drug in a long time that didn't come with a price tag that leapfrogged the last approved drug of its type," added Project Inform's Ryan Clary.

Howard Grossman, executive director of the American Academy of HIV Medicine, praised the company "for its price constraint during this critical time." He said federal funding for the AIDS Drug Assistance Program has not kept pace with the growing caseload and many state programs cannot afford to pay for many of the more recently approved drugs.