European Commission Suspends Roche’s License To Market Antiretroviral Viracept
The European Commission on Tuesday suspended Swiss pharmaceutical company Roche's license to market its antiretroviral drug Viracept because of contamination with the substance ethyl mesilate in certain lots of the drug, Reuters reports (Reuters, 8/7). According to the AP/International Herald Tribune, ethyl mesilate can damage DNA and lead to cancer (AP/International Herald Tribune, 8/7).
The European Medicines Agency in June recalled Viracept because of contamination. Roche in a statement said that it recalled all batches of the drug in Europe and other undisclosed countries in cooperation with EMA and Swissmedic, Switzerland's drug regulator. According to Roche, the drug was recalled after tests indicated that certain batches were contaminated with higher-than-normal levels of methane sulfonic acid ethyl ester -- a chemical normally used in the drug in small quantities.
William Burns, CEO of Roche's pharmaceutical division, said the impurity had been caused by the interaction of two chemicals in a vessel where the drug is produced. Roche later announced that it plans to establish patient registries to monitor the health of HIV-positive people who were taking the drug (Kaiser Daily HIV/AIDS Report, 7/24).
According to the European Commission, the suspension was based on scientific conclusions from EMA and consultations with members of the European Union. Roche expects to be able to market Viracept, which is known generically as nelfinavir, again in the European Union beginning in September or October, after EMA has examined new safety data, according to a spokesperson (Reuters, 8/7). Roche spokesperson Claudia Schmitt said the company is in "intensive discussions" with EMA "to validate the new manufacturing process for Viracept." Roche does not expect the suspension to affect the company's financial outlook for this year, the AP/Tribune reports (AP/International Herald Tribune, 8/7).