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Fuzeon

Enfuvirtide, with trade name Fuzeon®, is a novel antiretroviral drug used in combination therapy for the treatment of HIV-1 infection. It is currently marketed by Hoffmann-La Roche under the trade name Fuzeon. more...

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Fuzeon

Enfuvirtide is available only in injectable form since it is a peptide and would not survive digestion. The injections must be taken twice a day. This makes it inconvenient to take. With an estimated U.S. price of more than $25,000 for a year of Fuzeon, it is relatively expensive for an antiretroviral drug. Its inconvenience and price reserve it mostly for salvage therapy in patients with multi-drug resistant HIV.

The most common side effect is injection site reaction.

History

Trimeris Inc. began development on enfuvirtide in 1996 and initially designated it T-20. Trimeris partnered with Hoffmann-La Roche in 1999 to complete the drug's development. The medication has several disadvantages that resulted in its slow progress. It is difficult to manufacture, and is only available in an injectable form. The injections must be taken twice a day.

Its approval by the Food and Drug Administration (FDA) on March 13, 2003 made it the first of the new Fusion inhibitor class of antiretroviral drugs to be approved for use in the United States. It was approved on the basis of two studies (TORO 1 and TORO 2) which compared the effect of optimized regimens of antiretroviral medication with and without the addition of Fuzeon on serum viral load.

Mode of action

Enfuvirtide works by disrupting the HIV-1 molecular machinery at the final stage of fusion with the target cell, preventing uninfected cells from becoming infected. A biomimetic peptide, Enfuvirtide was rationally designed to mimic components of the HIV-1 fusion machinery and displace them, preventing normal fusion. Drugs that disrupt fusion of virus and target cell are termed entry inhibitors.

Greenberg, M. L. and N. Cammack (2004). "Resistance to enfuvirtide, the first HIV fusion inhibitor." J Antimicrob Chemother 54(2): 333-40.

Read more at Wikipedia.org

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FDA approves Fuzeon drug has N.C. roots
From BT Catalyst, 4/1/03

Fuzeon[TM], the novel treatment for HIV-1 conceived by Trimeris (Nasdaq: TRMS) of Durham, and later co-developed with Roche of Nutley, N.J., was recently approved by the U.S. Food and Drug Administration under its accelerated review process.

Fuzeon will be prescribed in combination with other antiretroviral agents for the treatment of HIV-1 infection in patients who are losing their resistance to the virus despite ongoing antiretroviral therapy.

"With Fuzeon, what we've essentially done is to take a piece of the virus and turn it against itself," said Dani Bolognesi, Ph.D., Trimeris' CEO. "Together with our partner Roche, Trimeris is proud to bring this innovative new therapy to the growing number of people with HIV who are in need of new treatment options."

Fuzeon is a fusion inhibitor, the newest crass of anti-HIV treatments in seven years. Unlike all currently approved anti-HIV drugs, Fuzeon blocks the virus from entering the human immune cell, preventing HIV replication that can devastate the immune systems of HIV-infected individuals. Fuzeon is administered as a twice-daily subcutaneous injection.

"This new fusion inhibitor is a significant breakthrough and its approval is a milestone event in the HIV epidemic," said Dr. Michael Saag, director of the AIDS Outpatient Clinic at the University of Alabama at Birmingham, where the drug underwent clinical trials.

The Fuzeon approval is also a milestone in North Carolina's efforts to catalyze a vibrant biotechnology industry, since it is the first "home Brown" human therapeutic to obtain FDA approval.

Trimeris was launched in 1993 as a spin-out of Duke University in Durham and was initially led by veteran entrepreneur Max Wallace, who saw the potential of the technology while managing technology transfer activities at Duke.

Wallace helped Trimeris attract venture capital in its early days, and the company also received start-up funding through the North Carolina Biotechnology Center.

The manufacturing of Fuzeon is currently being perfected in Roche's manufacturing facility in Boulder, Col. The process involves 106 steps, and is considered to be a major advancement in the large-scare chemical synthesis of peptides.

For more information visit the company's Web site.

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