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European licence for Roche HIV drug Viracept re-established by European Commission
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Roche ready to start re-supply of HIV medicine
http://www.roche.com
Roche announced today that the European Commission (EC) has re-instated the Viracept marketing authorization following its suspension earlier this summer. Roche welcomes the news and fully intends to re-supply Viracept (nelfinavir) as soon as possible. The timing of the re-introduction will vary from country to country and it is likely to be a few months before it is fully available again to prescribers and patients.
"We are pleased that the marketing authorisation for Viracept has been re-instated in Europe." said William M. Burns, CEO of Roche's Pharmaceutical Division "Our teams have worked diligently in manufacturing and in close collaboration with the health authorities, health care providers, NGO treatment providers and patient groups on the recall with the full intention of re-supplying this medication."
Viracept's license was suspended in August this year following the discovery that some of the drug batches contained a substance called ethyl mesylate sulphonate (EMS).
About Viracept
Viracept (nelfinavir), a protease inhibitor is supplied by Roche outside the US, Canada and Japan. Viracept was first introduced by Roche in 1999.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world's biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, a market leader in virology and active in other major therapeutic areas such as autoimmune diseases, inflammation, metabolism and central nervous system. In 2006 sales by the Pharmaceuticals Division totaled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche employs roughly 75,000 worldwide and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Roche's Diagnostics Division offers a uniquely broad product portfolio and supplies a wide array of innovative testing products and services to researchers, physicians, patients, hospitals and laboratories world-wide. For further information, please visit our website at www.roche.com.
All trademarks used or mentioned in this release are protected by law.
EU has lifted suspension on anti-AIDS drug, say makers Roche
19 October 2007, 10:57 CET
http://www.eubusiness.com
(BASEL) - Swiss pharmaceuticals giant Roche said Friday the European Commission had restored the licence to market the HIV drug Viracept in the European Union withdrawn after a contamination problem.
"The European Commission has reinstated the Viracept marketing authorization following its suspension earlier this summer," said a company statement.
On August 7, the European Commission suspended the licence due to the toxic contamination of some Viracept tablets, which Roche announced when it began a massive recall of the drug in June.
Tests had confirmed the presence of ethyl mesylate sulphonate (EMS), which is toxic to humans.
William M. Burns, chief executive of Roche's pharmaceuticals division, welcomed the decision.
"Our teams have worked diligently in manufacturing and in close collaboration with the health authorities, health care providers, NGO treatment providers and patient groups on the recall with the full intention of re-supplying this medication," he said.
Viracept has been on the market since 1999.
On Tuesday, Roche announced strong results for the first nine months of 2007, with a 12-percent jump in its turnover to 33.9 billion Swiss francs (20.2 billion euros, 28.7 billion dollars).
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