NEWARK, Calif. -- Depomed, Inc. (DEPO) today announced that it has entered into a definitive agreement to acquire the U.S. and Canadian rights to cebranopadol and its related follow-on compound from Grünenthal GmbH ("Grünenthal"). Cebranopadol is a novel, first-in-class analgesic in development for the treatment of moderate to severe chronic nociceptive and neuropathic pain and is an important addition to Depomed's leading portfolio in pain and neurology. Depomed anticipates advancing cebranopadol into Phase III development for chronic lower back pain (cLBP) and other pain indications by 2017. The deal adds a highly complementary development candidate with a strong efficacy profile, favorable tolerability and low abuse potential with patent protection into the 2030's to Depomed's broad commercial platform of pain and neurology marketed products.
"Cebranopadol is a truly differentiated molecule with a novel dual mechanism-of-action, functioning as a high-potency agonist of both the mu-opioid and the nociceptin receptors. Cebranopadol's pharmacology is likely to confer analgesic efficacy equivalent to that of traditional opioids in peripherally-mediated, nociceptive pain conditions, while potentially conferring great efficacy in neuropathic pain and other pain states characterized by more centralized pain," said Srinivas Rao, M.D., Ph.D., Chief Medical Officer of Depomed. "Moreover, the product does not appear to impact respiratory function to the degree that traditional mu-opioid receptor agonists do, and the nociceptin receptor pharmacology also appears to substantially mitigate the abuse potential of cebranopadol."
Continued Dr. Rao: "These unique and beneficial properties, along with a strong scientific rationale and a robust clinical package, translate to a strong probability of success - making cebranopadol a great addition to our portfolio. Developmentally, we have a well-defined pathway to follow that we believe has the potential to add tremendous value to both the chronic pain armamentarium and the company."
"The acquisition of this novel compound with its unique structure and characteristics fits perfectly with our long-term commitment to expanding our leading pain management portfolio," said Jim Schoeneck, President and Chief Executive Officer of Depomed. "This acquisition builds on Depomed's leadership in pain, our successful experience in drug development, and further demonstrates our continued ability to do financially creative acquisitions with the goals of improving the lives of patients and increasing shareholder value."
Under the terms of the agreement, Depomed has entered into a settlement agreement with Endo Pharmaceuticals, Inc., a subsidiary of Endo International Plc ("Endo") to resolve Depomed's ongoing patent litigation against Endo for alleged infringement of three of Depomed's patents by Endo's OPANA® ER product. As the formulator of OPANA® ER, Grünenthal indemnified Endo for certain intellectual property matters, including Depomed's ongoing patent infringement lawsuit against Endo. The settlement agreement grants Endo a non-exclusive patent license in the United States, and a covenant not to sue outside the United States, for the currently marketed form of OPANA® ER. In addition, Depomed is providing Grünenthal with a limited covenant not to sue under certain Depomed Acuform® drug delivery patents with specific drug substances as well as $25 million in cash. Depomed will also pay Grünenthal royalties on net sales and one-time net sales milestones. There are no clinical, regulatory or approval milestone payments. 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 upon the closing under the license agreement.
To date, cebranopadol has been studied in sixteen Phase I, four Phase IIa and three Phase IIb trials in painful diabetic peripheral neuropathy (PDPN), osteoarthritis (OA) and chronic lower back pain as well as a human abuse potential study. In total, cebranopadol has been studied in approximately 2,000 patients worldwide. In summary, these studies confirm a profile of high potency and efficacy with good tolerability and the potential for a lower abuse profile. Depomed anticipates conducting an End-of-Phase-II meeting with U.S. Food and Drug Administration (FDA) in 2016 and commencing Phase III development by 2017. Cebranopadol has patent protection through at least 2032 with the potential for patent term extension to 2037.
"Cebranopadol is a first-in-class drug candidate due in large part to its unique ability to bind with high affinity to not only classical opioid receptors, but also the nociceptin/ orphanin FQ peptide, or NOP, receptors which may offer improved management of some pain states with decreased side effects. Indeed NOP agonists have been shown to have a broad range of effects, and balanced agonist activity at the NOP and mu receptors may result in an improved safety profile – reduced tolerance and reduced risk of respiratory depression versus mu agonist activity alone," said Frank Porreca, Ph.D. Professor of Pharmacology and Anesthesiology, The University of Arizona College of Medicine at Tucson. "Arising from Grünenthal, a leader in the development of multifunctional molecules, cebranopadol has the potential to lead the way in novel analgesic therapy."
Cebranopadol is 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 (MOR). 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 dependence and respiratory depression. Cebranopadol has completed several Phase II trials in painful diabetic peripheral neuropathy (PDPN), osteoarthritis (OA) and chronic lower back pain (cLBP) and is ready for Phase III development.
Baker Botts L.L.P. represented Depomed in the connection with this transaction.
Depomed will host a conference call today, Tuesday, November 17, beginning at 5:00 p.m. EST (2:00 p.m. PST) to discuss the transaction. Participants can access the call by dialing 877-317-6789 (United States) or 412-317-6789 (international). The conference call will also be available via a live webcast on the Investor Relations section of Depomed's website at http://www.depomed.com. Access the website 15 minutes prior to the start of the call to download and install any necessary audio software. An archived webcast replay will be available on the Company's website for three months.
Depomed is a specialty pharmaceutical company that commercializes products for pain and neurology related disorders. Our NUCYNTA® franchise includes NUCYNTA® ER (tapentadol) extended release tablets indicated for the management of pain, including neuropathic pain associated with diabetic peripheral neuropathy (DPN), severe enough to require daily, around-the-clock, long-term opioid treatment, and NUCYNTA® (tapentadol), an immediate release version of tapentadol, for management of moderate to severe acute pain in adults. Gralise® (gabapentin) is a once-daily treatment approved for the management of postherpetic neuralgia. CAMBIA® (diclofenac potassium for oral solution) is a non-steroidal anti-inflammatory drug indicated for acute treatment of migraine attacks with or without aura in adults (18 years of age or older). Zipsor® (diclofenac potassium) Liquid Filled Capsules is a non-steroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain in adults. Lazanda® (fentanyl) Nasal Spray is an intranasal fentanyl drug used to manage breakthrough pain in adults (18 years of age or older) who are already routinely taking other opioid pain medicines around-the-clock for cancer pain. Gralise, Nucynta ER and various partner product candidates are formulated with Depomed's proven, proprietary Acuform® drug delivery technology. Additional information about Depomed may be found atwww.depomed.com.
NUCYNTA®, Gralise® CAMBIA®, Zipsor®, Lazanda® and Acuform® are registered trademarks of Depomed, Inc.
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995. The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties including, but not limited to, those related to the potential benefits of cebranopadol, the company's clinical development plans and expectations regarding cebranopadol and other risks detailed in the company's Securities and Exchange Commission filings, including the company's Annual Report on Form 10-K for the year ended December 31, 2014 and most recent Quarterly Report on Form 10-Q. The inclusion of forward-looking statements should not be regarded as a representation that any of the company's plans or objectives will be achieved. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
VP, Investor Relations and Corporate Communications
Canale Communications for Depomed