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Depomed Announces Closing of Acquisition of U.S. Rights to Cebranopadol From Grunenthal
Adds Phase III-Ready, New Chemical Entity to Depomed’s Broad Commercial Portfolio
NEWARK, Calif., Jan. 04, 2016 (GLOBE NEWSWIRE) -- Depomed, Inc. (Nasdaq:DEPO) today announced that on December 30, 2015 it closed the acquisition of the U.S. and Canadian rights to cebranopadol and its related follow-on compound from Grünenthal GmbH ("Grünenthal"). This follows the company’s receipt of termination of the required waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Cebranopadol is a novel, first-in-class analgesic in development for the treatment of moderate to severe chronic nociceptive and neuropathic pain.

“We are pleased to add this first-in-class, late-stage molecule to our commercial portfolio as it marks a further transformation of Depomed into a leading pain company,” said Jim Schoeneck, President and Chief Executive Officer of Depomed. “With the close of this transaction, our goals in the coming year are to present the results from various completed Phase II studies that enrolled over 2,000 patients, conduct an End-of-Phase-II meeting with the FDA as well as execute certain studies in support of Phase III drug product manufacturing. We anticipate advancing cebranopadol into Phase III trials for chronic lower back pain and other pain indications by 2017.”

Transaction Details

As previously announced on November 17, 2015, as part of the acquisition of cebranopadol, Depomed 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 granted 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.
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Source: press release, 1/04/16. http://investor.depomedinc.com/phoenix.zhtml?c=97276&p=irol-newsArticle&...

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Depomed Acquires U.S. Rights to Late-Stage, First-in-Class Pain Product from Grunenthal
- Adds Phase 3-Ready, New Chemical Entity with Patent Coverage to 2030's -
- Unique Molecule May Provide Opioid-like Efficacy with Lower Side Effect and Abuse Potential -
- Creative Deal Structure Secures Asset by Resolving Litigation and Minimizes Upfront Cash -
- Conference Call Today at 5:00 p.m. EST -

NEWARK, Calif., Nov. 17, 2015 /PRNewswire/ -- Depomed, Inc. (NASDAQ: 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."
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Source: press release, 11/17/15. http://investor.depomedinc.com/phoenix.zhtml?c=97276&p=irol-newsArticle&...

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Cebranopadol (GRT-6005)AnesthesiologyPain managementPan opioid receptor agonistOpioid receptors

Mechanism of action: Cebranopadol (GRT-6005) is an opioid analgesic of the benzenoid class that is an agonist of all four opioid receptors: nociceptin, μ-opioid, δ-opioid, and κ-opioid receptors.

Phase of Development: II

Event Type: Program status: Initiation of phase III trial

Dates: 2017-01-01 - 2017-06-30

Results: Pending