11/17/2015

• After the acquisition of Nucynta® (tapentadol) and Nucynta® ER (tapentadol extended release tables) for the U.S. territory by Depomed earlier this year, this is the second pain drug from Grünenthal’s Research and Development that will be added to Depomed’s portfolio of innovative medicines in pain and neurology
• Grünenthal and Depomed, Inc., applied a creative deal structure for this exclusive license agreement on Cebranopadol

Aachen, Germany, November 17, 2015. Grünenthal announced today the exclusive license agreement with Depomed, Inc. (DEPO), a California based specialty pharmaceutical company commercializing products for pain and neurology, on the development and commercialization of Cebranopadol for the U.S. and Canada. Cebranopadol is a novel, first in class, potent analgesic for chronic pain which has demonstrated its efficacy in multiple Phase II trials in moderate to severe chronic pain. The product is suited for oral, once-a- day treatment. It is the first of a new generation of innovative pain product discovered and developed by the family-owned, innovation-driven pain specialist Grünenthal. Cebranopadol is the second pain drug from Grünenthal’s Research and Development that will be added to Depomed’s portfolio after tapentadol, which was acquired by Depomed for the US territory from Grünenthal’s former partner Johnson & Johnson earlier in 2015.

Under the terms of the agreement, Depomed, Inc. will take full responsibility for further development, marketing and sales of Cebranopadol in the U.S. territory and Canada, while Grünenthal will keep the rights for the rest of the world. Depomed will pay Grünenthal an upfront payment of $25 million in cash, double-digit royalties on net sales of Cebranopadol as well as sales milestones.

As a major component of the upfront payment, Depomed has also entered into a settlement agreement with Endo Pharmaceuticals (“Endo”) to resolve Depomed’s ongoing patent litigation against Endo relating to OPANA® ER. As the formulator of OPANA® ER, Grünenthal indemnified Endo for certain intellectual property matters, including Depomed’s ongoing patent infringement lawsuit against Endo.

In addition, Depomed is providing Grünenthal with a limited covenant not to sue under certain Depomed patents for specific drug substances. The deal is expected to close in the fourth quarter of 2015, following termination or expiration of the waiting period under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 and completion of other customary closing conditions. The settlement agreement with Endo becomes effective on the closing under the license agreement.

“Since Depomed acquired Nucynta® from Johnson & Johnson earlier this year, we have been impressed by their performance”, states Prof. Eric-Paul Pâques, CEO Grünenthal and Chairman of the Corporate Executive Board. “Thus, we believe that Depomed would also be an ideal development partner for us for our new promising molecule. We are very pleased that Depomed will leverage its pain knowledge and its development and commercial capacities to make Cebranopadol a success.”

Grünenthal GmbH, a family-owned pharmaceutical company based in Aachen, Germany, discovered and started the development of Cebranopadol. Between 2010 and 2014, Grünenthal had partnered exclusive development and commercialization rights for the US and Canada with Forest Laboratories Ireland Limited, while Grünenthal held the rights in Europe and the rest of the world. This license agreement had been terminated on October 1, 2014, by Forest, after they had been taken over by Actavis (now Allergan). Since then, Grünenthal continued the worldwide development program as planned.

About Cebranopadol

Cebranopadol is a novel small molecule analgesic which was discovered by Grünenthal GmbH, Germany. Cebranopadol represents a novel, first-in-class potent analgesic that has a dual mechanism-of-action as an agonist of both the nociceptin receptor (NOP) and the mu-opioid receptor (MOP). These mechanisms, which have been shown to synergize, result in both a comparable efficacy and broader analgesic spectrum versus standard mu-opioid receptor agonists as well as an improved safety profile, particularly as it pertains to tolerance development and respiratory depression. Cebranopadol has completed several Phase II trials in painful diabetic peripheral neuropathy, osteoarthritis and chronic lower back pain and is now ready for Phase III development. Clinical experience with Cebranopadol is already available for approximately 2.000 patients treated for up to 6 months.

About Grünenthal

The Grünenthal Group is an independent, family-owned, international research-based pharmaceutical company headquartered in Aachen, Germany. We are an entrepreneurial specialist delivering true benefits to patients. By sustainably investing in research and development above the industrial average, we are committing to innovation in order to treat unmet medical needs and bring value-adding products to markets. Grünenthal is a fully integrated research & development company with a long track record of bringing innovative pain treatments and state-of-the-art technologies to patients. Altogether, the Grünenthal Group is present in 32 countries with affiliates in Europe, Australia, Latin America and the US. Grünenthal products are sold in more than 155 countries and approx. 5,300 employees are working for the Grünenthal Group worldwide. In 2014, Grünenthal achieved revenues of € 1.154 bn.

More information: www.grunenthal.com.

• Grünenthal GmbH exclusively licenses U.S. and Canadian rights of its innovative analgesic Cebranopadol to Depomed, Inc. (pdf, 205 KB)