UPDATE 1-Pharming drug gets special FDA status, shares jump
(Rewrites, adds background, updates shares)
AMSTERDAM Oct 11 (Reuters) - Dutch biotechnology firm Pharming PHAR.AS said the U.S. Food and Drug Administration (FDA) granted a special status to its recombinant human fibrinogen (rhFIB) drug, lifting its shares by 10 percent.
The FDA Orphan Drug designation, which provides a special treatment while developing drugs for rare diseases and conditions, was given to the drug which is being developed as a replacement therapy to treat bleeding in patients with fibrinogen deficiency.
The market for fibrinogen deficiencies is estimated to be over $500 million in the developed world, Pharming said in a statement on Thursday.
Pharming shares were up 9.8 percent at 3.47 euros by 1212 GMT after rising to 3.49 euros earlier. Before the announcement the stock was steady.
Pharming is also developing a drug which is purified from the milk of transgenic rabbits and is intended to treat acute attacks of hereditary angioedema (HAE). It would be the second medicine from a genetically engineered animal to get to market.
Pharming aims to file this drug, which will be marketed as Rhucin, with the FDA by the end of this year and is hoping to get approval from European authorities by then.
The company has said it was comfortable with analysts' forecasts that the product could sell between 500 million euros ($710.7 million) and 600 million a year as a treatment for HAE in the United States and Europe combined.
Analysts predict the drug should move the company into profit.
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