Depomed today announced that the 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."