QRxPharma : Approaching FDA Decision 6/18/2012 3:
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QRxPharma : Approaching FDA Decision
6/18/2012 3:31 AM ET
(RTTNews) - Australian biotech company QRxPharma Ltd. (QRX.AX: News ) (QRXPY) has just days left to know the FDA's decision on its acute pain-reliever candidate MoxDuo IR, which is under regulatory review. MoxDuo IR is an immediate-release oral capsule developed under the company's Dual Opioid platform technology, which is intended to provide effective analgesia while reducing the frequency and severity of opioid-related side effects.
For readers who are new to QRxPharma, here's a brief overview of the company's pipeline and the upcoming catalyst to watch out for...
MoxDuo IR, an immediate-release Dual Opioid pain therapy comprised of a patented 3:2 fixed ratio combination of morphine and oxycodone, is the company's lead product candidate. The company completed the NDA submission for MoxDuo IR in August of 2011, and it was filed under 505(b)(2) regulatory pathway that allows a company to rely, at least in part, on the FDA's findings of safety and/or effectiveness for a previously approved drug.
According to QRxPharma, MoxDuo IR has demonstrated equal or better pain relief with fewer incidences of moderate to severe opioid related side effects compared to current standards of care in clinical trials. In addition, the company also says that MoxDuo IR provides a significant safety benefit with less clinical respiratory risk than either morphine or oxycodone. Respiratory depression is found to be the leading cause of death from opioid treatment, says the company.
The FDA decision date is set for June 25, 2012. If things pan out the way as expected, QRxPharma plans to launch MoxDuo IR in the U.S. next quarter (3Q,2012).
QRxPharma has an agreement in place with Swiss company Actavis Inc. for the commercialization of MoxDuo IR in the U.S. acute pain marketplace that was inked last December. In April of this year, Watson Pharmaceuticals Inc. (WPI) agreed to acquire Actavis for $5.6 billion and the acquisition is expected to be completed in the fourth quarter of 2012.
As per the terms of the agreement, Actavis will pay QRxPharma royalties of 10% to 30% depending on net sales of MoxDuo IR, except for a period starting 3-6 months following launch during which QRxPharma will receive a 50% royalty on US$150 million in cumulative sales.
QRxPharma's other product candidates being developed under the Dual Opioid platform technology include,
* MoxDuo IV, an intravenous formulation for managing hospital based post-surgical pain, which has successfully completed a phase II comparative proof-of-concept study. QRxPharma signed a strategic alliance with Aoxing Pharmaceutical Co. in February 2010 for the development of MoxDuo IV for the China market.
6/18/2012 3:31 AM ET
(RTTNews) - * MoxDuo CR, a controlled-release oral tablet with abuse deterrent and tamper resistant technologies for chronic pain, which has successfully completed phase I studies. QRxPharma plans to to initiate phase II Proof-of-Concept clinical studies for MoxDuo CR around midyear 2012.
Actavis has the option to negotiate for the U.S. marketing and sales rights of MoxDuo IV and MoxDuo CR.
QrxPharma went public on the Australian Securities Exchange in May 2007. The company also has a Level 1 ADR and is listed on the International OTCQX under the ticker QRXPY.
On the ASX, QrxPharma is currently trading at A$1.73, up 5.15% on a volume of 118,551 shares.
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by RTT Staff Writer
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