April 19, 2012
Handa Pharmaceuticals, LLC (“Handa”), a specialty pharmaceutical company based in Fremont, California, today announced that it has entered into an exclusive acquisition and license agreement with Par Pharmaceutical, Inc. (NYSE: PRX) for Handa’s Abbreviated New Drug Application (“ANDA”) for Dexlansoprazole Delayed Release Capsules, a generic version of Takeda’s DEXILANT®. Handa believes that it is the first applicant to file an ANDA for the 60 mg strength of DEXILANT® containing a Paragraph IV certification under the provisions of the Hatch-Waxman Act, which would potentially provide 180 days of marketing exclusivity.
Under the terms of the agreement, Handa has received a payment from Par for the ANDA, giving Par the exclusive rights to market, sell and distribute Dexlansoprazole Delayed Release Capsules in the U.S. under the ANDA, subject to final FDA approval. Handa will receive a percentage of profits from the sales of the product.
Handa is currently involved in patent litigation concerning the ANDA in the U.S. District Court for the District of Northern California. Par will assume control of ongoing litigation.
According to IMS Health data, annual sales of DEXILANT® Delayed Release Capsules, 60 mg, in the U.S. are approximately $517 million.
About Handa Pharmaceuticals, LLC
Handa Pharmaceuticals, LLC is a specialty pharmaceutical company that was established in the San Francisco Bay area in November 2005. Handa’s executive leadership has a proven track record of developing controlled-release prescription pharmaceutical products that are difficult to formulate. For more information, please visit http://www.handapharma.com.
Any statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Handa’s current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Handa disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Handa’s current expectations depending upon a number of factors affecting Handa’s business. These factors include, among others, patents and other intellectual property rights held by competitors and other third parties and the uncertainty of the outcome of litigation related to such patents and intellectual property rights; the difficulty of predicting the timing or outcome of product development efforts and FDA or other regulatory agency approvals or actions; the impact of competitive products and pricing; market acceptance of and demand for Handa’s products; difficulties or delays in manufacturing; and other risks and uncertainties.
DEXILANT® is a registered trademark of Takeda Pharmaceuticals North America, Inc.