Reuters: Regulatory News: Basilea antifungal wins coveted U.S. orphan drug status

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Basilea antifungal wins coveted U.S. orphan drug status May 28th 2013, 07:07 Tue May 28, 2013 3:07am EDT * Orphan drug status means marketing exclusivity * Isavuconazole being developed with Japan's Astellas * Backing follows management shake-ups ZURICH, May 28 (Reuters) - Swiss biotech group Basilea has won coveted orphan drug status from U.S. health authorities for antifungal treatment isavuconazole, the company said on Tuesday. Orphan status is granted to drugs that treat conditions or diseases that affect fewer than 200,000 people in the United States. The designation usually comes with a seven-year marketing exclusivity period if the drug is approved for sale. "The granting of orphan designation for isavuconazole in the U.S. reflects the high medical need and is an important regulatory milestone for Basilea and our partner Astellas," chief Basilea medical officer Achim Kaufhold said in a statement. Isavuconazole, which treats both mould and yeast infections, is being developed with Japan's Astellas. The U.S. drug backing comes shortly after a string of shake-ups at Basel-based Basilea, including the departure of its chief financial officer just two months after that of the firm's founder and chief executive. Basilea faces a year of waiting for regulatory approval on its main product, antibiotic drug ceftobiprole. The company is in the process of answering questions from European agencies on the drug and said any possible approval could come in the fourth quarter. The firm has been hunting for a partner for ceftobiprole - which it hopes will make it to market to treat hospital and community-acquired pneumonia - for several years and said it was aiming for a partnership by the end of 2013. Link this Share this Digg this Email Reprints

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