Roche has suffered a setback with the news that the European Commission has suspended marketing authorisation for Viracept, the firm’s HIV drug which was recently recalled in June after contaminated batches were found.
Viracept (nefinavir) was temporarily pulled from the market by the European Agency for the Evaluation of Medicinal Products (EMEA) in June after it was discovered that certain batches of the drug had been contaminated with excess levels of ethyl mesilate, a substance used in the production of the drug which could cause cancer. Roche agreed to the suspension but may have been taken aback by this latest development because it may be some time before Viracept gets back on the market in Europe.
The Commission’s suspension, which is the first time it has ordered such a Europe-wide recall for a drug, has been made on the back of a recommendation from the EMEA and consultation with member states. More importantly, however, it added that “the suspension can only be lifted by a further decision of the Commission, after an assessment by the agency of new data”.
At the time of the temporary ban, the EMEA recommended that a toxicological study be carried out by Roche in order to calculate toxic levels of ethyl mesilate more precisely, as well as the establishment of a patient monitoring register which should include the patients who have been exposed to the contamination and all pregnant women and children who have ever taken Viracept, including those exposed in utero.
Roche, which believes that the contamination was a one-off, is hoping to start manufacturing the drug again for the European Union by October and said that it is in intensive discussions with the relevant authorities in order to validate the new manufacturing process for Viracept. The Basel-based company has stated that the recall did not affect the USA (where Viracept is marketed by Pfizer), Canada or Japan (where it is sold by Japan Tobacco), and its financial impact is negligible, for the timebeing at least.