QRxPharma Limited has executed the license and option agreement (LOA) with Europe based Actavis, Inc. which finalised the legal terms and conditions to commercialise MoxDuo IR in the US acute pain marketplace.

The LOA completion follows a December 20 2011 signing of a binding Letter of Intent (LOI) secured by a US$ 6 million non-refundable upfront signing fee to QRxPharma.

“Actavis is proving to be an exceptional partner. The strategic synergies between our companies and our collaboration at the joint steering committee level are critical success factors going forward,” said Dr John Holaday, managing director and chief executive officer, QRxPharma. “With the LOA now complete, we are focusing our ongoing energies towards supporting Actavis as we approach our PDUFA date and prepare for the anticipated launch of our first product, MoxDuo IR, in the third quarter.”Actavis’ CEO for the US, Doug Boothe, added, “Our launch plans for MoxDuo IR are on track and we remain convinced MoxDuo IR is very well suited to the experience and expertise of our marketing and sales teams. We are very optimistic about the opportunity for MoxDuo IR to successfully penetrate the $2.5 billion acute pain market in the US.”

Highlights of the strategic partnership include:

Actavis has exclusive rights to commercialise and further develop MoxDuo  IR for the US market while assuming all costs for product launch as well as  ongoing marketing and sales efforts in the US.

Commencing at MoxDuo IR launch, Actavis will pay QRxPharma royalties  of 10 per cent to 30 per cent depending on net sales thresholds, except for a period starting 3-6 months following launch where QRxPharma will receive a 50 per cent royalty on US$ 150 million in cumulative sales.

QRxPharma retains a co-promotion/profit-share right, whereby QRxPharma  can create its own sales force and provide up to 25 per cent of the effective selling effort to US prescribers at any time following the first 12 months after product launch.

QRxPharma owns the New Drug Application and is responsible for manufacturing at its contract manufacturer, DSM Pharmaceuticals, Inc.

QRxPharma retains the rights to MoxDuo IR, CR and IV outside the US.

The LOA also provides Actavis an option to negotiate for US marketing and sales rights of MoxDuo CR, a controlled release Dual-Opioid for chronic pain, as well as MoxDuo IV, a hospital-based intravenous formulation.  Exercise of the option for MoxDuo CR by Actavis is contingent upon achievement of specific MoxDuo IR sales milestones. The option for MoxDuo IV is time-based with expiry on January 31, 2013.

MoxDuo is a patented 3:2 ratio fixed dose combination of morphine and oxycodone. In headto-head comparisons with morphine, oxycodone, Percocet and placebo, more than 700 patients have been treated with MoxDuo IR in seven clinical trials over QRxPharma’s successful phase III programme.

QRxPharma Limited is a commercial-stage specialty pharmaceutical company focused on the development and commercialisation of new treatments for pain management.