Teva's new drug nears EU approval

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Teva's new drug nears EU approvalBy ZEV STUB

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Teva Pharmaceutical Industries' Parkinson's disease (PD) treatment Azilect (rasagiline) has been recommended for market approval in the European Union. The announcement should help boost Teva's stock, as it indicates that market approvals for the highly-touted drug may be closer than expected, said Moskowitz, an analyst for Friedman, Billings, Ramsey in Arlington, Virginia. Teva and its European marketing partner, H. Lundbeck A/S, said the European Medicines Agency's Committee for Medicinal Products in Human use issued a positive opinion recommending approval for the drug both as initial monotherapy in patients with early PD and as adjunct treatment in moderate-to-advanced disease. Following the recommendation, final marketing authorization for the EU is expected in the first quarter of 2005. The announcement should help "boost sentiments" for Teva's stock, which has declined in recent months on expectations that the company's flagship multiple sclerosis treatment Copaxone could lose market share to Biogen Idec's Antegren, Moskowitz said. Thursday's notice could indicate that Teva could have a second blockbuster drug ready for the market in two months, he added. The drug, which will be sold under the name Agilect in North America, has already been recommended as "approvable" in the US, but Teva has to meet privately with the Food and Drug Administration there before the final approval can be given. It is likely that there could be a hold-up as Teva negotiates for a better label that would expand the circumstances under which the drug would be prescribed, dragging out the period of uncertainty, Moskowitz suggested. The EU recommendation suggests that the drug, which was developed jointly by Teva and the Technion in Haifa, should sail to approvals in both countries, Moskowitz said. Worldwide sales for PD drugs reached $2.2 billion in 2003, with approximately 40% of this in Europe, Teva said. Moskowitz estimated that annual global sales of Azilect could eventually peak at $330m. -$350m., although he said the numbers he uses in his models are much more conservative. Teva's shares rose 1.4% to NIS 121.70 on the Tel Aviv Stock Exchange, and were up 1% to $27.70 Thursday morning on the Nasdaq market.

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