1/15/2015

• The three companies closely collaborate for the ongoing support of Nucynta^® (tapentadol), Nucynta^® ER (tapentadol) extended-release tablets and Nucynta^® (tapentadol) oral solution in the U.S. territory during the transition phase
• With this agreement, Grünenthal continues to pursue its goal to deliver true benefits to patients

Aachen, Germany, January 15, 2015. Grünenthal GmbH granted its consent with Janssen Pharmaceuticals Inc.’s (JPI) divestment of the license rights for Nucynta^® (tapentadol), Nucynta^® ER (tapentadol) extended-release tablets and Nucynta^® (tapentadol) oral solution in the U.S. territory to Depomed, Inc. (DEPO), the company announced today. During the transition period, the three companies work closely together for the ongoing support of these drugs.

Grünenthal GmbH, a family-owned pharmaceutical company based in Aachen, Germany, discovered and started the development of tapentadol. Since signing the license agreement in 2003, Grünenthal and Janssen Pharmaceuticals, Inc. have shared development responsibilities for Nucynta^® for acute and chronic pain conditions.

Under the terms of the agreement, Depomed, Inc. will take full responsibility for marketing and sales and will assume Janssen Pharmaceutical Inc.’s responsibility for the further clinical development of Nucynta^® in the U.S. territory, while Janssen Pharmaceuticals, Inc. will keep the rights for Canada, Japan and a number of other countries outside the United States.

“Since our collaboration started in 2003, Janssen Pharmaceuticals has always been a trustworthy, loyal and excellent partner for Grünenthal”, states Prof. Eric-Paul Pâques, CEO Grünenthal and Chairman of the Corporate Executive Board. “We are very happy that Depomed is our new partner in the U.S., as both companies have a very strong knowledge of the analgesic market and we believe there is a strong opportunity for Nucynta® growth. We will provide full support during the hand-over so the patients with moderate to severe pain can continue to benefit from Nucynta^® in the U.S.”

About Nucynta^®
Nucynta^® (tapentadol) and Nucynta^® ER (tapentadol) extended-release tablets are opioid-based medicines used for treatment of pain. In the U.S., Nucynta® (tapentadol) is indicated for the management of moderate-to-severe acute pain in adults. Nucynta^® ER (tapentadol) is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate and of neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Full product labeling including Boxed Warnings for Nucynta^® and Nucynta^® ER is available at www.Nucynta.com. Nucynta^® (tapentadol) oral solution is an approved oral form of tapentadol that has not been launched.

About Grünenthal
The Grünenthal Group is an independent, family-owned, international research-based pharmaceutical company headquartered in Aachen, Germany. Building on its unique position in pain treatment, its objective is to become the most patient-centric company in the field of pain and thus to be a leader in therapy innovation.
Grünenthal is one of the last five remaining research-oriented pharmaceutical companies with headquarters in Germany which sustainably invests in research and development. Research and development costs amounted to about 27 percent of revenues in 2013. Grünenthal’s research and development strategy concentrates on selected fields of therapy and state-of-the-art technologies. We are intensely focused on discovering new ways to treat pain better and more effectively, with fewer side-effects than current therapies.
Altogether, the Grünenthal Group has affiliates in 25 countries worldwide. Grünenthal products are sold in more than 155 countries and approx. 5,500 employees are working for the Grünenthal Group worldwide. In 2013, Grünenthal achieved revenues of €901 mn.
More information: www.grunenthal.com

• Transfer of the license rights for Nucynta® (tapentadol) in the U.S.  (pdf, 32.1 KB)