Mallinckrodt New Drug Application For MNK-155 Accepted For Review By FDA Controlled Substance Analgesic Combination Product Uses Depomed's Proprietary Acuform® Technology
NEWARK, Calif., May 28, 2014 /PRNewswire/ -- Depomed, Inc. (NASDAQ: DEPO) announced today that the U. S. Food and Drug Administration (FDA) has accepted for filing a New Drug Application (NDA) from Mallinckrodt (NYSE: MNK) for MNK-155. MNK-155 is an investigational extended-release oral formulation of hydrocodone and acetaminophen that has been studied for the management of moderate to moderately severe acute pain where the use of an opioid analgesic is appropriate. MNK-155 is formulated with Depomed's Acuform® drug delivery technology.
The NDA acceptance triggers a $5 million milestone payment to Depomed under a license agreement between Depomed and Mallinckrodt. Depomed is also entitled to an additional milestone payment of $10 million upon approval of the NDA and high single digit royalties on net sales of MNK-155, if approved.
"We are pleased that the FDA has accepted the NDA for MNK-155 for filing, and we look forward to potential approval of this extended-release product," said Jim Schoeneck, President and CEO of Depomed. "Depomed's proprietary Acuform drug-delivery technology is also being used (under similar royalty terms) by Mallinckrodt in XARTEMIS XR™ (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets (CII), an extended-release oral formulation of oxycodone and acetaminophen approved for management of acute pain severe enough to require use of an opioid analgesic. We believe that the combination of royalties on net sales of XARTEMIS XR and additional milestones and royalties on MNK-155, if it is approved, can make a significant contribution to Depomed's future revenues."
Depomed is a specialty pharmaceutical company that commercializes products for pain and neurology related disorders. 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 and various partner product candidates are formulated with Depomed's proven, proprietary Acuform® drug delivery technology. Additional information about Depomed may be found at www.depomed.com.
"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 regulatory approval of our partner's product candidates 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, 2013 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.
August J. Moretti
Depomed, Inc. 510.744.8000
Canale Communications for Depomed
SOURCE Depomed, Inc.