Noven, Shire Have Positive Data for ADHD Treatment

Noven Pharmaceuticals Inc. on Wednesday reported positive preliminary results from studies on an attention deficit hyperactivity disorder (ADHD) treatment it is developing with Shire Pharmaceuticals Group Plc .

Shire, Britain’s No. 3 drugmaker, said the once-a-day skin patch would offer an alternative to pill-based therapies.

Noven said the results will be included in an amended drug application pending with the U.S. Food and Drug Administration to address issues raised by the FDA’s review in April 2003.

Two studies examined the treatment, known as the methylphenidate transdermal system, in children ages 6 to 12 previously diagnosed with ADHD. In these studies, use of the treatment was well tolerated and the objectives of both studies were achieved, Noven said.

“It’s good news, but we only think it’ll be a niche product,” said Navid Malik, an analyst at broker Collins Stewart in London.

Malik forecast peak annual sales for the Noven product of about $75 million. He has a “buy” rating on Shire’s shares.

Earlier this year, Canada suspended sales of Shire’s top-selling hyperactivity drug Adderall XR following the sudden death of some patients taking it. U.S. regulators had previously reviewed the death data and allowed Adderall XR to remain on the market with a revised label warning that the drug should not be used in children or adults with structural heart problems.

Shares of Noven rose 33 cents, or 1.87 percent, to $17.94 in morning trading on the Nasdaq. Shares of Shire fell 1.5 pence to 618.5 on the London Stock Exchange.

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