Deal follows Shire’s decision to withdraw its MAA and product recalls.

Noven Pharmaceuticals is reacquiring global rights to Shire’s Daytrana, a transdermal patch for the treatment of attention deficit hyperactivity disorder (ADHD) in patients 6 to 17 years old. The book value of the assets to be disposed is approximately $95 million, according to Shire. The drug was approved in 2006 by the FDA and generated net sales of $71 million in 2009.

Last March, however, Shire withdrew its MAA after being asked by European regulators to conduct an additional clinical study on Daytrana in a European patient population. Since then, the company has also made three separate recalls of the product because some of the patches did not meet liner-removal specifications.

When it pulled the MAA, Shire noted that its February 2009 acquisition of UCB’s drug for ADHD, Equasym®, gave it entrance into the European market. Shire paid UCB €55 million for both the immediate- (IR) and extended-release (XL) formulations, but the deal excludes the U.S., Canada, and Barbados. Equasym XL is approved and marketed in 10 countries, and IR is marketed in four countries.

With the divestiture of Daytrana, Shire’s marketed ADHD portfolio in the U.S. and Canada now includes three drugs: Adderall XR, Vyvanse, and Intuniv. The firm says that its 2010 outlook of non-GAAP earnings trending toward $4.00 per ADS is unchanged.

Daytrana, a methylphenidate transdermal system, was developed and manufactured by Noven and licensed globally to Shire in 2003. Pursuant to today’s product and trademark acquisition agreement, Noven will regain substantially all rights and assets related to Daytrana, including the product’s NDA, and will assume certain related liabilities.

Shire will continue to commercialize the product through closing of the transaction, scheduled for October 1. Once the transfer is completed, Daytrana will be marketed and sold by Noven Therapeutics, the firm’s specialty pharmaceuticals marketing and sales unit. U.S. promotion is expected to begin in March 2011. Noven Therapeutics currently promotes the antidepressant Pexeva® and bipolar disorder medications Stavzor® and Lithobid® to psychiatrists and other target physicians in the U.S.

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