Paladin Labs signs agreement with QRxPharma for acute pain product

Comtex News Network

Oct 12, 2012 (Datamonitor via COMTEX) --Paladin Labs Inc., a specialty pharmaceutical company, has entered into a licensing agreement with QRxPharma Limited, an Australian-based specialty pharmaceutical company, whereby Paladin received the exclusive rights to market and sell MOXDUO in Canada.

MOXDUO is a novel, patented, immediate release, fixed dose formulation of morphine and oxycodone for the treatment of acute pain.

Under the terms of this agreement, Paladin will pay $500,000 upfront and provide a series of potential sales performance, regulatory and reimbursement milestone payments that can total up to $25 million. In addition, Paladin will pay a series of tiered double-digit royalties on sales of MOXDUO in Canada. Further financial details related to the agreement were not disclosed.

MOXDUO is a dual-opioid product combining fixed doses of morphine and oxycodone in a 3:2 ratio of morphine to oxycodone, providing dosing ranges of 3/2mg, 6/4mg, 9/6mg, and 12/8mg.

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.

"This transaction continues to demonstrate our ability to add novel, differentiated pain products to our therapeutic portfolio that help meet patient needs and complement our existing activities in the pain category," said Mark Beaudet, interim president and CEO of Paladin. "MOXDUO is unique in that it will be the only dual opioid combination product indicated for the treatment of acute pain, offering an improved safety profile versus single existing agents in Canada. MOXDUO will complement our existing portfolio in Canada including 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."

"We are delighted to announce our strategic collaboration with Paladin," said Dr John Holaday, managing director and CEO of QRxPharma. "Their 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."

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