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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.

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Fuzeon NDA submitted
From BT Catalyst, 10/1/02

Trimeris Inc. (Nasdaq: TRMS) of Durham and development partner Roche of Nutley, N.J., recently submitted a New Drug Application (NDA) to the FDA for approval to market Fuzeon[TM] for the treatment of HIV-1 infection.

Formerly known as T-20, Fuzeon is in a new class of anti-HIV drugs called fusion inhibitors. It is combined with other antiretroviral agents for treating the infection.

Unlike existing anti-HIV drugs that work inside the cell, Fuzeon has a unique mode of action that blocks HIV from entering the human immune cell, making it active against HIV that is resistant to other drugs.

Roche and Trimeris have requested priority review status from the FDA. If granted, Fuzeon would be reviewed within six months.

The regulatory submissions for Fuzeon are based on 24-week data from two large, international Phase III trials, which indicate that patients on Fuzeon plus an individualized background regimen of other antiretroviral drugs were twice as likely to achieve undetectable levels of HIV compared to patients who received an individualized background regimen alone. Fuzeon also provided a significant increase in immune cells at 24 weeks.

In parallel with the filing, Roche and Trimeris confirmed the completion of the next major manufacturing milestone at the Roche Colorado manufacturing facility--validation of the first three commercial batches of active ingredient for Fuzeon.

"Fuzeon was one of the most difficult scientific and manufacturing challenges we have faced, but despite these challenges we have developed Fuzeon at the fastest pace possible in response to this increasing patient need," said Georges Gemayel, a vice president at Roche.

In related news, Trimeris recently filed plans with the Securities and Exchange Commission for a proposed public offering of two million shares of common stock.

Net proceeds from the offering will be used to fund various research and development projects, commercialization activities and general corporate purposes.

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

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