Product of the Year

Trimeris, Inc.

Description

Trimeris, Inc. (NASDAQ: TRMS), is a Durham-based biopharmaceutical company engaged in the discovery, development and commercialization of novel therapeutic agents for the treatment of viral disease. The core technology platform of fusion inhibition is based on blocking viral entry into host cells. FUZEON, recently approved in the US and European Union, is the first in a new class of anti-HIV drugs called fusion inhibitors. Trimeris’ second fusion inhibitor product candidate, T-1249, has received fast track status from the FDA and is in Phase I/II clinical testing for the treatment of HIV. Trimeris is developing FUZEON and T-1249 in collaboration with F. Hoffman-La Roche Ltd.

Reasons for winning the award

Trimeris received FDA approval for its anti-HIV drug FUZEON in March 2003 and received European approval for the drug in May 2003. These major approvals came after several years of clinical trials and testing for the drug. Developed by Trimeris with collaborative partner Roche, FUZEON is the first drug to block entry of HIV into immune cells. It represents the first new class of anti-HIV treatments in seven years. Unlike all currently approved anti-HIV drugs, FUZEON blocks HIV's ability to infect healthy immune cells.

Quote

"Trimeris is pleased that FUZEON has been recognized by the CED as the Product of the Year. Together with our partner Roche, we are proud to bring this innovative new therapy to the growing number of people with HIV who are in need of new treatment options. On behalf of the employees at Trimeris, we are truly honored to receive this award for entrepreneurial excellence." -- Dr. Dani Bolognesi, CEO and Chief Scientific Officer

History

Trimeris, Inc., which was founded in January 1993, originally spun out of Duke University behind the leadership of Max Wallace and other industry pioneers. By 1996, the company had filed for an Investigational New Drug (IND) and human clinical studies commenced. Approximately one year later, in October 1997, they raised more than $34 million in proceeds for an Initial Public Offering. Phase II clinical studies were initiated in 1998 for FUZEON. In 1999, Trimeris filed an IND for T-1249, and the company also formed a collaborative agreement with F. Hoffmann-La Roche Ltd. In 2001, Phase III pivotal clinical studies were initiated in 2001 for FUZEON, and by the following year Trimeris announced positive top-line clinical data from two pivotal studies. In 2003, Trimeris received US and EU regulatory approvals and launched FUZEON.

Photo courtesy of BP Studios.

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