MONTREAL, CANADA--(Marketwire - Oct. 9, 2012) - Paladin Labs Inc. ("Paladin") (TSX:PLB), a leading Canadian specialty pharmaceutical company, today announced that it has entered into a licensing agreement with QRxPharma Limited (ASX:QRX) and (OTCQX:QRXPY), 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. According to IMS Canada, the value of the total immediate release opioid market in Canada totaled almost $170 million in 2011. Under the terms of this agreement, Paladin will pay US$500,000 upfront and provide a series of potential sales performance, regulatory and reimbursement milestone payments that can total up to US$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.
"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".
MOXDUO is a patented, immediate release 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. More than 700 patients with moderate to severe pain following surgery have been treated with MoxDuo IR in seven head-to-head clinical trials with morphine, oxycodone, Percocet® and placebo. 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 Food and Drug Administration (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.
About Paladin Labs Inc.
Paladin Labs Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian and world markets. With this strategy, a focused national sales team and proven marketing expertise, Paladin has evolved into one of Canada's leading specialty pharmaceutical companies. Paladin's shares trade on the Toronto Stock Exchange under the symbol PLB. For more information about Paladin, please visit the Company's web site at www.paladinlabs.com.
QRxPharma Limited is a commercial- stage specialty pharmaceutical company focused on the development and commercialisation of new treatments for pain management. Based on a development strategy that focuses on enhancing and expanding the clinical utility of currently marketed compounds, the Company's product portfolio includes both late and early stage clinical drug candidates with the potential for reduced risk, abbreviated development paths, and improved patient outcomes. QRxPharma entered into a strategic collaboration with Actavis Inc. in December 2011 for the commercialisation of immediate release MOXDUO® in the US acute pain market. Additionally, the Company's clinical pipeline includes an intravenous (IV) and continuous release (CR) formulation of MOXDUO. For more information, visit www.qrxpharma.com.
This press release may contain forward-looking statements and predictions. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. The Company considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared, but cautions that these assumptions regarding the future events, many of which are beyond the control of the Company and its subsidiaries, may ultimately prove to be incorrect. Factors and risks, which could cause actual results to differ materially from current expectations, are discussed in the annual report as well as in the Company's Annual Information Form for the year ended December 31, 2011. The Company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information or future events and except as required by law. For additional information on risks and uncertainties relating to these forward-looking statements, investors should consult the Company's ongoing quarterly fillings, annual report and Annual Information Form and other fillings found on SEDAR at www.sedar.com.