Shire is selling the global rights to Daytrana, its patch for attention deficit hyperactivity disorder, back to the treatment’s developer and manufacuturer, Noven Pharmaceuticals of the USA.
The patch was originally licensed to Shire in 2003 and was launched in the USA in 2006. Daytrana (methylphenidate transdermal system) is indicated for the treatment of ADHD in patients aged 6 to 17.
However last March, Shire decided to withdraw a submission in Europe for Daytrana after regulators had requested an additional clinical study in a European patient population. Also, the earlier acquisition of non-US rights to the instant- and extended-release versions of UCB’s ADHD drug Equasym (methylphenidate) led to a shift in strategy with Shire using those products to get entry into the European ADHD market.
Shire noted that the book value of the assets to be disposed is $95 million, or a gross, pre-amortisation value of $150 million. The deal, effective October 1, will not affect Shire’s 2010 full-year earnings guidance of $4.00 per share.
Noven, which was acquired a year ago by Japan’s Hisamitsu Pharmaceutical Co, noted that Shire’s net sales of the product in 2009 were $71 million. It also said that US promotion of Daytrana is expected to begin in March 2011.
Chief executive Jeffrey Eisenberg added that by “applying the focused strategies and resources” of the Miami-headquartered firm, “we believe Noven will be well-positioned to continue to raise awareness of Daytrana”.
