Fuzeon (T-20) is the first drug in a new class of antiretrovirals known as fusion inhibitors. Unlike other antiretrovirals, fusion inhibitors block the entry of HIV into cells. It was developed by Trimeris (a company formed in 1993 by the scientists who discovered the compound at a federally supported research program at Duke University) and Hoffman-LaRoche. The drug was granted marketing approval by the FDA on March 13, 2003 after an accelerated approval. According to Roche, the price in the U.S. and Europe will be over USD 20,000 per patient per year, making Fuzeon by far the most expensive antiretroviral drug.
|Government Involvement in R&D|
"This invention was made with Government support under Grant No. AI-30411-02 awarded by the National Institutes of Health. The Government has certain rights in the invention."
We have lost money since inception and, as of December 31, 2002, had an accumulated deficit of approximately $264.6 million. We have received revenue only from federal small business innovative research grants, otherwise known as SBIR grants, an investigative contract, and an initial collaboration payment and a milestone payment from Roche, and have not generated any revenue from product sales or royalties. We may never generate significant revenue from product sales or royalties.
Collaborations between Dr. Eric Hunter and colleagues at the UAB CFAR with Dr. Dani Bolognesi and colleagues at the Duke University CFAR and Trimeris, Inc., have led to the discovery of novel peptide inhibitors of HIV-1 fusion and the definition of their mechanism of action. Pentafuside (T-20, DP-178), which is a synthetic peptide derived from a predicted helical domain of the HIV transmembrane protein, gp41, is a novel anti-HIV drug that demonstrated in vivo antiviral activity in a HuPBMC-SCID mouse model as evidenced by a reduced HIV-viral load in plasma, lymph nodes, spleen and peritoneal cells. This drug which inhibits an early event in HIV replication, was then evaluated in phase I clinical trials at UAB, demonstrating a full translational effort from bench to bedside.
|Private Research Funding|
In the United States and Canada, Roche and Trimeris will share equally development expenses and profits for the two fusion inhibitors. Outside of these two countries, Roche will fund all development costs and pay Trimeris undisclosed royalties on net sales of these products. Roche will make an initial cash payment to Trimeris of $10 million and up to an additional $78 million in cash and funding upon achievement of developmental, regulatory and commercial milestones. [By the end of December, 2002 none of the additional $78 million had been paid out, according to the firm's SEC Form 10-K]
The Table below summarizes the enrollment and duration of the clinical trials conducted on T-20. For more detailed information on these trials, see CPTech page on T-20 clinical trials trials.
|Protocall #||Phase||Number of Patients||Duration||Investigator/ Contact|
|TRI-001||I/II||17||14 Days||Michael S. Saag
University of Alabama at Birmington
|I/II||12||24 Weeks||Colleen Cunningham,
SUNY Upstate Medical School
|TRI-003||II||78||28 Days||Joseph Eron
University of North Carolina, Chapel Hill
|II||70||48 Weeks||Cal Cohen, Director
Community Research Initiative of New England
|T-20 206||II||71||48 Weeks||Jacob Lalezari
Quest Research Institute
|T-20 208||II||46||48 Weeks||Joseph Wheat
Indiana University School of Medicine
|T-20 301||III||Approx.500||48 Weeks||Michael Saag
University of Alabama, Birmington
|T-20 302||III||Approx.500||48 Weeks||.|
|Scientists Leading Trimeris|
As a co-founder and member of the Board of Directors of Trimeris since 1993, Dr. Bolognesi has played a major role in the company’s development since its inception... While at Duke, Dr. Bolognesi and his research team contributed to the discovery of AZT—the first anti-HIV drug, identified the HIV protein targeted by fusion inhibitor drugs, and established a central laboratory that supported all HIV vaccine clinical trials sponsored by the National Institutes of Health.
As a co-founder of Trimeris, Dr. Matthews has played a major role in directing Trimeris' research and development throughout the firm’s history... From 1984 through 1999, Dr. Matthews held several positions at the Duke University Center for AIDS Research, most recently Associate Professor of Experimental Surgery. His research group identified T-20 and related compounds as inhibitors of HIV fusion and viral entry.
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