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The source of this article is Reuters: http://tinyurl.com/4calt UPDATE 2-Schwarz files rotigotine for US, Europe approval Wed Sep 29, 2004 12:04 PM ET By Sitaraman Shankar FRANKFURT, Sept 29 (Reuters) - Schwarz Pharma has filed for approval to market its Parkinson's Disease patch rotigotine in Europe and the United States, the German firm said on Wednesday, marking a step in its transformation from a generic drugmaker. Schwarz (SRZG.DE: Quote, Profile, Research) expects peak annual sales of 350 million euros ($431 million) from rotigotine, which is vital to the company in reducing dependence on its main product, a generic copy of AstraZeneca's (AZN.L: Quote, Profile, Research) anti-ulcer treatment Prilosec. The drug is the first new chemical entity -- or invented molecule -- from Schwarz to be submitted for approval. "It's a milestone for Schwarz, and the company becomes interesting again as a result," said Sal. Oppenheim analyst Marcus Konstanti. "New products like rotigotine will have higher margins than the current business, which is mature and suffering from competition," he said. Schwarz said in a statement that the patch was intended to treat patients with early stage Parkinson's Disease, a nervous disorder characterised by problems in coordinating movement. "The estimated review time by the FDA (Food and Drug Administration) in general is 15-17 months, so we expect a launch in the first quarter of 2006 in the United States if all goes well," said a Schwarz spokeswoman. "We expect a launch in Europe at around the same time," she added. Schwarz said in a statement that the drug, formulated to supply rotigotine to the body continuously for a period of 24 hours, had been christened Neupro. Schwarz shares, which have run up 45 percent this year on hopes for rotigotine and epilepsy treatment harkoseride, closed 1.45 percent higher at 30.13 euros, outpacing the mid-cap MDAX index , which rose 0.7 percent. CHANGING STORY The filing of rotigotine will help move the focus of investors away from generic Prilosec, a drug that lifted Schwarz out of obscurity. From late 2002 to August 2003, Schwarz raked in windfall profits as the only seller of generic Prilosec, but competition cropped up from Mylan Laboratories (MYL.N: Quote, Profile, Research) , Novartis (NOVN.VX: Quote, Profile, Research) and Canada's Apotex, and the drug has become less important to the mid-sized German drugmaker. The company's profits have slid this year, and the focus has shifted to new products from its research pipeline. Konstanti, who has a "strong buy" rating on the stock, said he expected a stream of pipeline-related news in the next 18 months. "If all milestones are reached in the next 18 months, the share price could rise by more than 50 percent," he said. Rotigotine is also being developed as a treatment for restless leg syndrome, a disease characterised by crawly sensations in the leg, and Schwarz is expecting peak annual sales of more than 200 million euros from that use of the drug. The company is counting on a set of specialty generic drugs to tide over a lean period until rotigotine and harkoseride can hit the market. -------------------------------------------------------------------------------- © Copyright Reuters 2004. All rights reserved. Any copying, re-publication or re-distribution of Reuters content or of any content used on this site, including by framing or similar means, is expressly prohibited without prior written consent of Reuters. Quotes and other data are provided for your personal information only, and are not intended for trading purposes. Reuters, the members of its Group and its data providers shall not be liable for any errors or delays in the quotes or other data, or for any actions taken in reliance thereon. © Reuters 2004. All rights reserved. Republication or redistribution of Reuters content, including by caching, framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world. ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn