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Roche says it will recommence marketing Viracept in EU despite suspension

The EU Commission suspends marketing authorisation for AIDS drug Viracept, Roche says it plans to recommence marketing of the AIDS drug in September or October

On 7 August, the EU Commission said it had suspended marketing authorisation for AIDS drug Viracept following the same action by the European Medicines Agency (EMEA) in June.

The EMEA's suspension came after manufacturer Roche initiated a recall of all batches of Viracept (nelfinavir) in the EU and some other regions, due to the discovery of a chemical impurity in some production batches.

According to Roche, analysed batches of the recalled drug showed higher-than-normal levels of ethyl mesylate, a genotoxic substance that can damage DNA and may trigger cancer.

Supplies of Viracept in the US, Canada, Japan and Korea were not affected, as Pfizer manufactures the product sold in these countries.

According to the EU Commission, the suspension can only be lifted by a further decision by the commission, which will come after an assessment by the EMEA of new data.

In response, Roche has stated that it plans to recommence marketing of the AIDS drug in September or October 2007, pending approval by EU authorities. This decision comes in spite of the fact that Viracept already held a tenuous market position and despite impact of its recall in Europe being limited.

As one of the earlier protease inhibitors (PIs), Viracept's revenues were influenced by entry on to the market of later PIs such as Abbott's Kaletra, Bristol Myers-Squibb's Reyataz and Tibotec's Prezista. These drugs address issues associated with the earlier PIs, such as poor patient compliance caused by high pill burdens, pharmacokinetic problems and lipodystrophy.

As a result Viracept's sales dropped by approximately 55 per cent between 2002 and 2006 in the US, France, Germany, Italy Spain and the UK, according to IMS data.

With only a few patients still left on Viracept, there has been speculation that the drug's withdrawal from market could cause Roche to lose its remaining patients as consultants are forced to switch them onto newer PIs or even completely new treatment regimes. If patients can tolerate these new drugs, consultants may not see the need to switch them back onto Viracept once it re-enters the market.

8th August 2007

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