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UPDATE 1-Pharming drug gets FDA orphan status, shares jump
April 27, 2009 / 11:15 AM / 9 years ago

UPDATE 1-Pharming drug gets FDA orphan status, shares jump

* Drug targets premature aging in children

* Status allows accelerated review, market exclusivity

* Shares up 26 pct, from being flat before statement

(Writes through, adds detail)

    AMSTERDAM, April 27 (Reuters) - Dutch biotechnology firm Pharming (PHAR.AS) said on Monday its Prodarsan drug had been awarded an Orphan Drug designation for the treatment of Cockayne Syndrome by the U.S. Food and Drug Administration (FDA). Pharming shares were up 26 percent at 0.54 euros by 1100 GMT, topping gainers in Amsterdam, after flat trading at 0.43 euros just before the announcement.

    Cockayne Syndrome, which is the initial target of Prodarsan, is a rare genetic disease in which children suffer from accelerated (or premature) aging, while developing severe aging diseases.

    The FDA’s Orphan Drug designation is reserved for new therapies being developed to treat diseases or conditions that affect fewer than 200,000 people in the United States.

    The status entitles the drug to an accelerated review process, tax benefits, exemption from user fees and a seven-year period of market exclusivity in the United States after product approval. (Reporting by Harro ten Wolde; Editing by David Holmes) (harro.tenwolde@reuters.com; Reuters Messaging: harro.tenwolde.reuters.com@reuters.net; +31 20 504 5017)

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