HEALTH CARE REPORT: New Drug for HIV Patients

Nutley-based pharmaceutical company Roche and Trimeris, Inc., Durham, N.C., announce that FUZEON, a novel treatment for HIV-1, has been approved by the U.S. Food and Drug Administration (FDA), following a six-month priority review. FUZEON, in combination with other antiretroviral agents, is for the

FUZEON represents the first new class of anti-HIV treatments in seven years. The treatment blocks the virus from entering the human immune cell, preventing HIV replication that can devastate the immune systems of HIV infected individuals.

"This new fusion inhibitor is a significant breakthrough and its approval is a milestone event in the HIV epidemic," says Dr. Michael Saag, director, AIDS Outpatient Clinic, University of Alabama at Birmingham. "Patients are becoming resistant to our best therapies and they need new options. This drug attacks the virus in a new way, so it can work for patients whose virus is resistant to other therapies."

Because initial demand for FUZEON may exceed supply following commercial availibity, Roche and Trimeris have developed, and are now finalizing, a US Progressive Distribution Plan to provide FUZEON to patients and to ensure uninterrupted supply to patients once they begin therapy, the companies say.

According to a news report, the price point of FUZEON is about $20,500 per patient, per year. Even at this high cost, the demand should be filled because Roche can currently only support 3,000 patients worldwide, the report says.

"FUZEON is yet another example of Roche's long-standing commitment to advancing the treatment of HIV," says George B. Abercrombie, president and CEO, North America Pharmaceuticals Operations, Roche. "FUZEON also represents a major advancement in the large-scale chemical synthesis of peptides. This cutting edge process has been sucessfully implemented at the Roche manufacturing facility in Boulder, Colorado. FUZEON adds an important dimension to our growing HIV product portfolio and opens the door for a new treatment paradigm in HIV."