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UPDATE 2-Shire ADHD drug approved for US adults, shares jump

Wed Apr 23, 2008 11:56am EDT
 
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(Adds company, analyst comments, updates shares)

By Mark Potter

LONDON, April 23 (Reuters) - Britain's Shire Plc (SHP.L: Quote, Profile, Research, Stock Buzz) received a boost on Wednesday when its biggest drug hope, Vyvanse for attention deficit hyperactivity disorder (ADHD), was approved by U.S. regulators to treat adults.

Shares in Britain's third-biggest drugmaker jumped as much as 7 percent to 983 pence after the earlier-than-expected decision from the U.S. Food and Drug Administration (FDA).

Shire had expected to receive a so-called approvable letter from the FDA, which would have signalled its intention to back the medicine, pending further information. The straight approval raised hopes that Vyvanse sales this year would receive a boost.

Shire SAID in February that its forecast for Vyvanse sales $350 million to $400 million this year assumed the drug would be approved to treat U.S. adults by the middle of this year.

A spokeswoman said on Wednesday that Shire would start marketing Vyvanse to adults in "the next several weeks," but declined to comment on whether this would affect sales expectations for this year.

Shares in Shire, which is due to report first-quarter results on Friday, closed up 6.6 percent at 979 pence, valuing the business at about 5.7 billion pounds ($11.3 billion).

The U.S. Centres for Disease Control and Prevention has said that about 7.8 percent of all school-aged children, or about 4.4 million U.S. children, have been diagnosed with ADHD at some point in their lives, Shire said.   Continued...

 

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