Roche Announces Data Supporting Use of Fuzeon in Patients Who Benefit From At Least Two Other Medications
Switzerland-based pharmaceutical company Roche yesterday at the Sixth International Congress on Drug Therapy in HIV Infection in Glasgow, Scotland, presented new data indicating that the experimental antiretroviral drug Fuzeon, co-developed with Durham, N.C.-based Trimeris, is most effective when used by HIV patients for whom at least two other drugs in their combination therapy are still working, the Raleigh News & Observer reports. Fuzeon, one of a new class of fusion inhibitors, is designed to be used in combination with other antiretroviral therapies and "is eagerly awaited" by HIV-positive people who have developed resistance to other antiretroviral drugs (Ranii, Raleigh News & Observer, 11/19). The drug makers announced that after 24 weeks of treatment, all treatment-experienced HIV-positive patients -- regardless of demographics, disease stage or treatment history -- benefited from Fuzeon. The majority of study participants through 24 weeks of treatment found that the twice daily injection of the drug was "manageable" and did not cause "substantial" changes in their daily routines (Roche/Trimeris release, 11/18). Fuzeon has received priority review status by the FDA, and the agency is scheduled to review the drug by March 16, 2003 (Kaiser Daily HIV/AIDS Report, 10/28). "The combination of better than expected efficacy, tolerability and adherence data with the increasing incidence of drug resistance means demand for Fuzeon will be greater than initially anticipated," Dr. David Reddy, head of HIV/AIDS drugs at Roche, said (Reuters, 11/18). However, the News & Observer reports that "the [market] gains could be offset" by the cost of the drug, which is "expected to be unprecedented." Although a price has not yet been set, some analysts believe that Fuzeon will cost $12,000 or more per patient per year. Roche has said that Fuzeon will likely be the most expensive antiretroviral drug on the market due to its "complex and trailblazing manufacturing process," the News & Observer reports. Most drugs are manmade chemicals, but Fuzeon is a naturally occuring peptide, or string of amino acids. Roche and Trimeris have warned that initial demand for the drug may exceed the supply of the drug, which will be made in Boulder, Colo. (Raleigh News & Observer, 11/19).
FDA Panel Recommends Approval of Pegasys in Combination
An FDA panel on Friday recommended approval of drug maker Roche's pegylated interferon Pegasys for use with its ribavirin Copegus for the treatment of hepatitis C virus, Reuters reports. The FDA, which usually follows the recommendations of its panels, last month approved the use of Pegasys by itself as a treatment for HCV and is expected to issue a decision on the drug's usage with Copegus by Dec. 3. If Roche wins FDA approval for the Pegasys-Copegus combination treatment, it would put the company in position to challenge Schering-Plough's current "dominance" of the $1 billion market for hepatitis C treatments (Reuters, 11/15). Schering-Plough, which has been "the established leader" in hepatitis C medications "for years," according to Schering-Plough spokesperson Robert Consalvo, also manufactures a brand of pegylated interferon, Peg-Intron. Consalvo said that physicians' and patients' familiarity with the Schering-Plough product and the fact that Roche's Pegasys is not "in any way better" than Peg-Intron will keep Schering-Plough on top of the hepatitis C treatment market. Although the two companies' combination treatments have not been studied "head-to-head," Roche's combination therapy effectively controlled HCV in 46% of patients who are "hardest to treat," compared with 41% effectiveness achieved in a different study of Schering-Plough's combination therapy. According to Reuters, Roche is also counting on the "convenience" of its combination therapy, which only has to be taken once a week, to encourage doctors and patients to use it instead of Schering-Plough's medications, one of which must be taken three times per week. "Differences in the drugs are subtle," Richard Evans, an analyst at the investment research firm Sanford Bernstein & Co., said, adding, "This is a marketing battle, not a clinical contest." Both Roche and Schering-Plough have suffered recent losses and could benefit from successful sales of their hepatitis C therapies (Silverman, Newark Star-Ledger, 11/17).