Noven Pharmaceuticals, Inc confirmed that Shire plc, the global licensee of Daytrana (methylphenidate transdermal system), withdrew the European Marketing Authorization Application (MAA) for Daytrana for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). In connection with this announcement, Shire confirmed its commitment to Daytrana in the US, where the product has been approved and prescribed as a paediatric treatment for ADHD since 2006.

Shire stated that its decision to withdraw the MAA was based on the fact that European regulatory authorities had requested an additional clinical study for Daytrana in a European patient population, and that Shire planned to enter the European ADHD market through the previously-announced pending acquisition of an oral methylphenidate product that is already approved in Europe.

"Although we are disappointed with Shire's decision not to pursue European approval, our 2009 financial guidance - provided on March 5, 2009 - did not include any revenues or other financial contribution from European sales of Daytrana," said Michael Price, Noven's vice president & chief financial officer. "Accordingly, our 2009 net revenue guidance range of $110 million to $115 million remains unchanged and unaffected."

Noven Pharma is a specialty pharmaceutical company engaged in the research, development, manufacturing, marketing and sale of prescription pharmaceutical products.