10 Oct 2012, BioSpectrum Bureau , BioSpectrum
Singapore: Australia's QRxPharma has collaborated with Canadian specialty pharmaceutical company, Paladin Labs on licensing agreement for Canadian commercialization rights of MOXDUO, a patented, immediate release formulation of morphine and oxycodone.
Under the license agreement, Paladin will receive exclusive rights to commercialise 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.
Dr Mark Beaudet, interim president and CEO, Paladin, said that, "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."
Dr John Holaday, MD and CEO, QRxPharma, said that, "QRxPharma will work closely with Paladin to submit an NDS application to Health Canada in the first half of 2013. 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 US 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," Dr Holaday added.