Hoffmann-La Roche and Trimeris Unveil New Manufacturing Plant to Make Experimental Antiretroviral T-20
Officials from pharmaceutical companies Hoffmann-La Roche, a unit of Roche Holding AG, and Trimeris Inc. on Thursday unveiled a new plant at Roche Colorado in Boulder that is designed specifically to produce the experimental antiretroviral drug T-20, the Denver Post reports. T-20 belongs to a new class of drugs called fusion inhibitors, which block the virus before it invades a cell. The drug was specifically designed for patients who have developed resistance or intolerance to standard antiretroviral treatment (Austin, Denver Post, 5/24).
The Roche Colorado plant, which was completed in February, is currently processing the first "shakedown," or commercial-sized batch, of T-20. The batch is in the purification stage and "looks good," according to company executives (Locke, Dow Jones News Service, 5/23). The company plans to submit its application for "fast-track" FDA approval for T-20 by the fall (Denver Post, 5/24). Patients who received T-20 as part of their antiretroviral therapy in Phase III clinical trials showed a "significant additional decrease" in their viral levels, compared to those receiving standard antiretroviral combination therapy without T-20 (Kaiser Daily HIV/AIDS Report, 5/17). Company officials also noted that T-20 produced fewer side effects than other drugs. Officials did not yet have an estimated price for T-20 but said the price will "justif[y] the cost of manufacturing" the drug. Hoffmann-La Roche has already spent "hundreds of millions of dollars" on T-20 and expects to spend $500 million more on development and manufacturing (Denver Post, 5/24).