TAINAN TAIWAN, November 1, 2016 – Handa Pharmaceuticals, Inc. (“Handa”), a specialty pharmaceutical company based in Tainan, Taiwan, announced today that Par Pharmaceutical, Inc. (“Par”), an operating company of Endo International plc (NASDAQ: ENDP) (TSX: ENL) has begun shipping four dosage strengths (50 mg, 150 mg, 200 mg and 300 mg) of quetiapine fumarate extended release (ER) tablets, the generic version of AstraZeneca’s SEROQUEL XR®. As marketer and distributor of the product, Par will have 180 days of marketing exclusivity for these four first-to-file strengths and will share profits with its partners, Handa and Deerfield Generics, L.P., a portfolio company of Deerfield Management Company, L.P. “Par’s launch represents a significant milestone for the product and for Handa as a company,” said Bill Liu, Handa’s Chairman and CEO. “We are very pleased with the outcome.”
SEROQUEL XR® is a once-daily tablet approved in adults for add-on treatment to an antidepressant for patients with major depressive disorder (MDD) who did not have an adequate response to antidepressant therapy; acute depressive episodes in bipolar disorder; acute manic or mixed episodes in bipolar disorder alone or with lithium or divalproex; long-term treatment of bipolar disorder with lithium or divalproex; and schizophrenia.
According to IMS Health data, U.S. sales of SEROQUEL XR® for the four dosage strengths marketed by Par are approximately $911 million for the 12 months ended September 30, 2016.
About Handa Pharmaceuticals, Inc.
Handa Pharmaceuticals, Inc. is a specialty pharmaceutical company with headquarters in Tainan, Taiwan, and offices in Taipei, China, and the United States. 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.tw
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.
SEROQUEL® and SEROQUEL XR® are registered trademarks of the AstraZeneca group of companies.