Noven Pharmaceuticals, Inc. today announced that it has entered into a Product and Trademark Acquisition Agreement (the "Agreement") with affiliates of Shire plc ("Shire") pursuant to which Noven will acquire global rights to Daytrana® (methylphenidate transdermal system) from Shire.
Daytrana®, developed and manufactured by Noven, was originally licensed globally to Shire in 2003 and was approved and launched in the U.S. in 2006. The product is indicated for the treatment of Attention Deficit Hyperactivity Disorder ("ADHD") in patients 6 to 17 years old. Daytrana® should be used as a part of a total treatment program for ADHD that may include counseling or other therapies. Shire's net sales of the product in 2009 were $71 million.
The Agreement provides that Noven will acquire substantially all rights and assets related to Daytrana®, including the product's New Drug Application, and will assume certain related liabilities. Shire will continue to commercialize the product through closing of the transaction, scheduled for October 1, 2010.
Once transferred to Noven, Daytrana® will be marketed and sold by Noven Therapeutics, Noven's specialty pharmaceuticals marketing and sales unit, with U.S. promotion of the product expected to begin in March 2011. Noven Therapeutics currently promotes the oral prescription products Pexeva®, Stavzor® and Lithobid® to psychiatrists and other target physicians in the U.S.
Jeffrey Eisenberg, Noven's President and Chief Executive Officer, said: "We are excited to add Daytrana® to the product portfolio of Noven Therapeutics. Since 2006, Daytrana® has been an important therapeutic alternative for patients with ADHD and their physicians. Applying the focused strategies and resources of Noven Therapeutics, we believe Noven will be well-positioned to continue to raise awareness of Daytrana®, with the ultimate goal of helping patients manage their ADHD."