Noven Pharmaceuticals Inc. Confirms Shire plc's Withdrawal of European Marketing Application for Daytrana
MIAMI--(BUSINESS WIRE)--Noven Pharmaceuticals, Inc. (NASDAQ:NOVN - News) today confirmed that Shire plc, the global licensee of Daytrana® (methylphenidate transdermal system), has announced its withdrawal of 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 U.S., where the product has been approved and prescribed as a pediatric 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 Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the research, development, manufacturing, marketing and sale of prescription pharmaceutical products. Noven's business and operations are focused in three principal areas – transdermal drug delivery, the Novogyne joint venture, and Noven Therapeutics, Noven's specialty pharmaceutical unit. Noven is committed to developing and offering products and technologies that meaningfully benefit patients, its customers and its industry partners. For more information, visit www.noven.com.
Except for historical information contained herein, the matters discussed in this press release contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve substantial risks and uncertainties. Actual results, performance or achievements could differ materially from those contemplated, expressed or implied by the forward-looking statements contained herein. Readers should refer to the risk factors in Noven's Annual Report on Form 10-K for the year ended December 31, 2008 for a discussion of the factors that could cause actual results to differ from those contemplated, expressed or implied by the forward-looking statements contained herein. Unless required by law, Noven undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
Noven Pharmaceuticals, Inc., Miami Joseph C. Jones, Vice President – Corporate Affairs, 305-253-1916