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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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Trimeris raises $102.4m, Fuzeon fast-tracked
From BT Catalyst, 12/1/02

Trimeris Inc. (Nasdaq: TRMS) of Durham recently raised about $102.4 million through a public offering of 2,400,000 shares of common stock.

Net proceeds from the offering will be used to fund the clinical development and commercialization of Trimeris' anti-HIV drug candidates, Fuzeon[TM] and T- 1249, and for overall research and development, working capital and general corporate purposes.

The offering was conducted by a group of underwriters led by New York-based Morgan Stanley & Co. Inc. and Goldman, Sachs & Co. The co-managers were Lehman Brothers Inc. of New York and Banc of America Securities LLC of San Francisco.

In related news, Trimeris and Roche of Nutley, N.J., announced recently that their New Drug Application (NDA) for Fuzeon[TM] has been granted priority review status by the U.S. Food and Drug Administration (FDA). Priority designation is granted to medications that, if approved, address unmet medical needs, offering a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious or life-threatening disease.

The priority review designation establishes a target six-month review period for the Fuzeon[TM] NDA, which was submitted by Roche and Trimeris in September 2002.

Fuzeon[TM], a fusion inhibitor drug, is designed for the treatment of HIV-1 in combination with other antiretroviral agents.

For more information visit the company Web site at www.trimeris.com.

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