Lugano, Switzerland, November 17, 2015 – Helsinn Group announced today that the U.S. District Court for the District of New Jersey has ruled in favor of Helsinn Healthcare S.A. in the patent infringement lawsuit for antiemetic agent ALOXI® (palonosetron hydrochloride) brought by Helsinn together with Roche Palo Alto LLC (Roche) against Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries, Ltd. (collectively “Teva”) in the United States, where it was determined that the formulation patent claims for ALOXI are valid and infringed.

Since 2011, Helsinn and Roche filed patent infringement lawsuits in the U.S. District Court for the District of New Jersey, against Dr. Reddy’s Laboratories, Ltd., Dr. Reddy’s Laboratories, Inc. (collectively “Dr. Reddy’s”), Sandoz Inc. (“Sandoz”) and Teva, who were the first to submit Abbreviated New Drug Applications (ANDAs) for ALOXI. Of these companies, Helsinn has already made settlements with Sandoz and Dr. Reddy’s, and under the conditions of the settlements, in principle, neither Sandoz nor Dr. Reddy’s is allowed to launch a generic version of palonosetron hydrochloride via an ANDA prior to September 30, 2018, except under certain circumstances.

In this decision which concerns Teva, the court ruled that the patents at issue are valid and are infringed. The term of these formulation patent rights plus pediatric exclusivity currently provides coverage for ALOXI through July 30, 2024.

In addition, patent infringement lawsuits were brought by Helsinn and Roche against several other companies who subsequently filed ANDAs or 505(b)(2) applications for ALOXI after Dr. Reddy’s, Sandoz and Teva.  Some of these lawsuits have been settled and the remaining lawsuits are currently being disputed in U.S. District Courts.  Helsinn and Roche continue to aggressively litigate these cases, and the outcome of those litigations and any resolutions reached by the parties will ultimately determine the date of generic entry.

About the Helsinn Group

Helsinn is a family-run, privately owned pharmaceutical group focused on building quality cancer care with a large portfolio of products. Founded in 1976 with headquarters in Lugano, Switzerland, Helsinn also has operating subsidiaries in Ireland, and the U.S. and a representative office in China. Helsinn’s business model is focused on the licensing of pharmaceuticals, medical devices and nutritional supplement products in the therapeutic area of cancer care. Helsinn Group in-licenses early-to-late stage new chemical entities, completing their development by performing preclinical and clinical studies and associated manufacturing activities. Helsinn then prepares necessary regulatory filings in order to achieve marketing approvals worldwide. Helsinn’s products are out-licensed to its global network of marketing and commercial partners that have been selected for their local market knowledge and high ethical standards. Helsinn supports these partners by providing a full range of product and scientific management services, including commercial, regulatory, and medical marketing advice. In March 2013, Helsinn established a new commercial organization within its subsidiary, Helsinn Therapeutics (U.S.), Inc., in order to conduct direct sales and marketing activities within the U.S. market. Helsinn’s products are manufactured according to the highest quality, safety, and environmental standards at Helsinn’s GMP facilities in Switzerland and Ireland from where they are then supplied worldwide to customers.

Further information on Helsinn Group is available at:

For more information, please contact:

Helsinn Group

Paola Bonvicini

Head of Communication & Press Office

Tel: +41 91-985-21-21

[email protected]

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