European
Commission Suspends Roche's License To Market PI Nelfinavir (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).
08/08/07
Source
Kaiser
Daily HIV/AIDS Report. European Commission Suspends Roche's License To Market
Antiretroviral Viracept. August 8, 2007.
