QRxPharma, a commercial-stage specialty pharmaceutical company based in Bedminster, N.J., signed a licensing agreement with Paladin Labs, specialty pharmaceutical company based in Montreal, for the Canadian commercialization rights to Moxduo, a patented, immediate-release formulation of morphine and oxycodone.
"[Paladin’s] sector experience, consistent record of growth in branded pain products, and strong balance sheet to support the launch of MOXDUO made Paladin our best choice for the Canadian market," said John Holaday, CEO and managing director, QRxPharma.
Paladin will receive exclusive rights to commercialize immediate release Moxduo in Canada and assume responsibility for the New Drug Submission (NDS), all product launch costs, as well as ongoing marketing and sales efforts. QRxPharma will receive tiered double-digit royalties and up to $25 million in milestone payments on achievement of specific sales, regulatory and reimbursement targets, in addition to a non-refundable, non-creditable up-front payment of $500,000. QRxPharma retains the Canadian rights to the intravenous and controlled release formulations of Moxduo, which are in clinical development.
"QRxPharma will work closely with Paladin to submit an NDS application to Health Canada in the first half of 2013,” said Holaday. “The Canadian regulatory application will also incorporate efficacy and safety data from a recently completed respiratory safety study (Study 022), which was not part of the Moxduo New Drug Application (NDA) submitted to the FDA. This study, involving 375 patients, demonstrated that patients receiving Moxduo had an appreciably lower risk of experiencing medically significant oxygen desaturations than patients receiving equi-analgesic doses of morphine or oxycodone."
Mark Beaudet, CEO and interim president, Paladin, added, "Paladin Labs has extensive experience growing branded pain products. Moxduo will complement our existing prescription portfolio in Canada which includes already launched products Metadol, Pennsaid, our market-leading Tridural and Abstral, as well as hydrocodone ER which awaits regulatory filing in Canada. Moxduo will become another important piece of our future growth and continued expansion in a Canadian therapeutic category that is important for our business and future strategy."