NEWARK, Calif., March 12, 2014 /PRNewswire/ -- Depomed, Inc. (Nasdaq: DEPO) today announced that the U.S. Food and Drug Administration (FDA) approved Mallinckrodt plc's New Drug Application (NDA) for XARTEMIS™ XR (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets (CII), previously known as MNK-795, for the management of acute pain severe enough to require opioid treatment and in patients for whom alternative treatment options (e.g., non-opioid analgesics) are ineffective, not tolerated or would otherwise be inadequate. The release profile of XARTEMIS XR combines Mallinckrodt's newly patented technology, including design, formulation, pharmacokinetic and release characteristics, and Depomed's advanced Acuform® drug delivery technology.
The NDA approval triggers a $10 million milestone payment to Depomed under Depomed's license agreement with Mallinckrodt. Depomed will recognize the entire milestone payment in Q1 2014. Depomed will also receive high single digit royalties on net sales of XARTEMIS XR.
"We are pleased the FDA has approved XARTEMIS XR and that our Acuform technology has contributed to this important new therapy option for patients and their physicians," said Jim Schoeneck, President and CEO of Depomed. "We expect to receive significant recurring royalty revenue from Mallinckrodt's commercialization of XARTEMIS XR. Mallinckrodt has also licensed the Acuform delivery technology under equivalent royalty and milestone terms for its MNK-155 product candidate, which has been studied for moderate to severe acute pain. Mallinckrodt has indicated that it expects to file an NDA for MNK-155 in the second half of their 2014 fiscal year. FDA acceptance of the MNK-155 NDA would trigger a $5 million milestone payment to Depomed and approval by the FDA would trigger an additional $10 million milestone payment to Depomed."
Depomed, Inc. 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. Zipsor® (diclofenac potassium) Liquid Filled Capsules is a non-steroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain in adults. 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). 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 filings and potential approval of a New Drug Application for our partner's product candidate 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, 2012 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2013. 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
Canale Communications for Depomed
SOURCE Depomed, Inc.