AEGiS-AP: FDA to Review New AIDS Drug

Important note: Information in this article was accurate in 2002. The state of the art may have changed since the publication date.

FDA to Review New AIDS Drug

Associated Press - Friday October 11, 2002

New York (AP) - Swiss pharmaceutical giant Roche and its U.S. partner Trimeris Inc. said Friday that the U.S. Food and Drug Administration granted a priority review to their AIDS drug, Fuzeon.

The priority review means the drug will go through the approval process within six months instead of up to 12 months. Priority reviews are reserved for what are believed to be breakthrough treatments for major diseases for which there is no cure.

The two companies filed their application for Fuzeon on Sept. 16, so the review process should be finished by March 16, 2003.

Fuzeon is a potentially expensive drug that represents a new class of AIDS medicines that attacks the virus in a different way from existing treatments. It will be targeted for patients with drug-resistant strands of the virus, and be used in combination with other drugs.

AIDS activists are excited about the new treatment but fear its cost will put it beyond the reach of many patients. Basel-based Roche and Durham, N.C.-based Trimeris will not discuss price, but experts have said the drug will cost between $10,000 and $15,000 a year.

Fuzeon is a very difficult drug to make, requiring 106 steps to produce the active substance.

Fuzeon is the first in a class known as fusion inhibitors, which are designed to block HIV from entering blood cells. It acts on the third stage of that entry process, known as fusion.

In morning trading on the Nasdaq Stock Market, Trimeris shares were up 2.5 percent, or $1.09 a share, at $45.31.

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