QRxPharma Limited (QRX), a pharmaceutical developer of central nervous system (CNS) disorder and pain management drugs with multiple products in early and late-stage clinical trials, and China Aoxing Pharmaceutical Company (CAXG), an established pharmaceutical company with the largest and most advanced manufacturing facility in China, announced a strategic alliance today.
The two companies will work hand in hand to develop a new intravenous drug based on QRX’s proprietary oxycodone/morphine Dual-Opioid™ technology. The new drug, known as MoxDuo®IV, is designed for moderate to severe pain.
Funding for development of the new drug will be provided by CAXG, which will then have exclusive rights to marketing the drug in China, while QRX will retain ownership of the drug and usage rights for any clinical work done in development for the purposes of registering the product outside China.
Managing Director and CEO of QRX, Dr. John Holaday, was pleased at the opportunity to move the drug’s development along while gaining access to “an important and rapidly growing market” provided by the strategic alliance.
Dr. Holaday noted that the ability to leverage CAXG’s technical resources would streamline the drug’s developmental cost profile, and he went on to assure interested parties that the two companies would vigilantly pursue requirements by both the China State Food and Drug Administration (SFDA) and US Food and Drug Administration (FDA), the respective pharmaceutical regulatory bodies in each nation.
Having also licensed the rights to market MoxDuo®IR in China – an immediate-release capsule which is currently in Phase 3 trials in the US – CAXG anticipates finalization of proceedings related to this second drug in late March of this year.
Chairman and CEO of CAXG, Zhenjiang Yue, expressed his excitement at the chance to co-develop the two promising drugs, and said the partnership further solidified CAXG’s “leading position in the rapidly growing narcotics and pain management market in China”.
The start of a proof-of-concept study, designed to compare how safe and effective MoxDuo®IV is versus IV morphine for post-operative hip replacement surgery pain, was announced by QRX in July of last year, and data generated by this study should serve as a benchmark for the clinical benefits of MoxDuo®IV when results become available in 2Q 2010.
Additionally, the results will constitute a clinical trial framework for CAXG, and thus help in obtaining any future New Drug Applications (NDA’s) with the FDA.