Mallinckrodt, Depomed rise on FDA priority review for MNK-795 in pain
This article was originally published in Scrip
Investors drove shares of Mallinckrodt up 3.6% in morning trading on 29 July after the firm disclosed its new drug application (NDA) for its investigational pain drug MNK-795 was accepted by the US FDA and granted a priority review.
Mallinckrodt is seeking the FDA's OK to market MNK-795, a controlled-release oral formulation of oxycodone and acetaminophen, as a treatment for moderate to severe acute pain when the use of an opioid analgesic is appropriate.
"This marks an important milestone for us as our first NDA acceptance as an independent specialty pharmaceutical company," declared Mallinckrodt CEO Mark Trudeau, whose firm recently completed its spinout from Covidien (scripintelligence.com, 2 July 2013).
Shares of Mallinckrodt closed at $46.20 on 29 July, a gain of $1.15, or 2.5%.
Shares of Mallinckrodt's partner, Depomed, also got a 3.2% boost on 29 July, gaining 20 cents in morning trading, before closing at $6.33, up16 cents, or 2.6%.
The NDA acceptance triggered a $5 million milestone payment to Depomed under its license agreement with Mallinckrodt.
Depomed also is entitled to an additional milestone payment on approval of the NDA, plus high single-digit royalties on net sales of MNK-795.
The medicine was designed using Depomed's advanced Acuform drug delivery technology with tamper-resistant properties.
Depomed CEO Jim Schoeneck said his firm’s Acuform technology also is being used under similar milestone and royalty terms by Mallinckrodt for another of its investigational pain drugs.
"Should either or both of these products be approved, we believe that the combination of milestones and royalties on net sales can make a significant contribution to Depomed's future revenues," he said.
Mallinckrodt said its NDA submission for MNK-795 was based on data from a comprehensive clinical program, which included 14 clinical trials involving 1,281 patients evaluating the pharmacokinetics, efficacy, safety and abuse liability of the drug.