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Mallinckrodt New Drug Application For MNK-155 Accepted For Review By FDA

Stocks in this article: DEPO MNK

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."

About Depomed

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.



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