Viracept loses EU marketing licence

The European Medicines Agency (EMEA) has suspended the marketing licence for Roche's HIV/AIDs drug Viracept (nelfinavir) after contaminated batches were discovered earlier this month.

The EMEA says the quality and safety of Viracept cannot be ensured at this time.

The suspension means the drug cannot be produced or prescribed with immediate effect. The EMEA has also ordered Roche to carry out toxicology studies on animals to establish the effect the contamination could have on patients. Preliminary results from these studies are expected to be available by the end of the year.

"A meeting held at the EMEA on 13 June 2007 concluded that there are currently insufficient data to establish which doses of ethyl mesilate may be toxic in humans," said the EMEA in a statement.

The EMEA's Committee for Medicinal Products for Human Use (CHMP) has asked Roche to identify the group of patients who have been exposed to contaminated batches of Viracept in order to establish appropriate follow-up and monitoring.

"The current view of the CHMP is to follow patients exposed to high levels of contaminant in the batches of Viracept released since March 2007, all pregnant women who have ever been exposed to Viracept and all children who have ever been exposed to Viracept, including those exposed in utero."

Roche also has to reassure the EMEA that the manufacturing problem responsible for the contamination at its plant in Basel, Switzerland, has been resolved.

"We take the welfare of patients extremely seriously. With the knowledge we have to date, we consider the risk to patients to be low, however we want to be sure patients can be followed and these registries will allow us to do just that ," says William B Burns, CEO pharmaceuticals division of Roche.

"The root cause of the elevated levels of impurity observed recently has been identified and we are following up on the agreed actions with EMEA," concludes Burns.

The contaminated batches were discovered earlier this month and the contamination occurred in March 2007, affecting three months' worth of supplies.

According to some analysts, Viracept is prescribed to few patients and its recall will not change HIV market dynamics. Around 45,000 patients worldwide are on Viracept, with 19,000 of those in Europe. Roche says Italy, France and Spain are the European countries which have the highest number of patients on Viracept.

However, some are saying it could lead to Roche losing the patients it has as doctors switch them on to newer protease inhibitors (Pis) or new treatment regimes. If these treatments work, doctors may see little point in swtiching them back on to Viracept. Viracept was launched in Europe in 1998 as one of the earlier PIs.