By Kim Coghill
Hoffmann-La Roche Inc. and Trimeris Inc. expanded their agreement to discover and develop novel generations of HIV fusion inhibitor peptides.
Initially signed in 1999, the worldwide partnership focused on discovery, development and commercialization of two HIV fusion inhibitors, T-20 and T-1249. Under the new agreement, which is renewable annually after three years, the companies will expand their capability of discovering fusion inhibitors that have properties that are more attractive in the marketplace.
¿If one could reduce the frequency of injections from where they are now significantly, from once a day to once a week or something of that sort, that would be a tremendous advantage for the patient and the manufacturer,¿ said Dani Bolognesi, CEO, director and co-founder of Durham, N.C.-based Trimeris. ¿That is the goal of this program. In the meantime, we would hope to develop better drugs from the perspective of potency and resistance profiles.¿
Fusion inhibitors are a new class of HIV drugs designed to block the virus before it enters the host cell. Many people living with HIV have developed resistance to the drugs currently available, and Roche and Trimeris hope fusion inhibitor peptides will address the growing need for new products.
Under terms of the new agreement, Roche, of Nutley, N.J., and Trimeris will equally fund worldwide research, development and commercialization costs as well as share equally in profits from sales of new HIV fusion inhibitor peptides discovered after July 1, 1999.
Profits for T-20 and T-1249 will be split 50-50 in the United States and Canada, and in the remainder of the world, Trimeris will receive a double-digit royalty based on sales, Michael Recny, Trimeris¿ vice president of corporate development, told BioWorld Today.
Both T-20 and T-1249 have been granted fast-track status by the FDA.
Enrollment is nearly complete for the Phase III study of T-20, which is expected to be launched at the end of 2002. T-20 showed efficacy in a 1997 Phase I/II trial, reducing the viral load of HIV in patients¿ blood by 98 percent in the highest dosage group. A 1999 Phase II trial in 75 adults whose HIV viral loads were no longer suppressed by approved anti-HIV drugs produced a median viral load reduction ranging from 69 percent to 97 percent.
T-1249, which is currently in Phase I/II trials, demonstrated HIV suppression in animal models. T-1249 is expected to be launched two years after T-20.
Trimeris¿ stock (NASDAQ:TRMS) closed Tuesday at $45.55, down $1.34.