SYDNEY, AUSTRALIA and BEDMINSTER, NJ--(Marketwire - February 23, 2010) -
QRxPharma Limited and
China Aoxing Pharmaceutical Company (OTCBB:
CAXG) ("China Aoxing")
announced today a strategic alliance to collaborate in the development of
MoxDuo®IV, an intravenous formulation of QRxPharma's patented morphine and
oxycodone Dual-Opioid™ technology for the acute treatment of moderate to
severe pain. Under the terms of the agreement, China Aoxing will fund the
development of MoxDuo®IV for the China market in exchange for exclusive
marketing rights in China. QRxPharma will retain ownership of MoxDuo®IV
and may use the clinical work completed by China Aoxing for product
registration purposes outside of China.
"We are pleased to announce this strategic alliance as it furthers our
MoxDuo®IV development objectives and provides access to an important and
rapidly growing market," said Dr. John Holaday, Managing Director and Chief
Executive Officer, QRxPharma. "By leveraging China Aoxing's technical
resources, we are able to cost effectively advance development of
MoxDuo®IV. Our team will work closely with China Aoxing to ensure the
development program meets both US Food and Drug Administration (FDA) and
China State Food and Drug Administration (SFDA) regulatory requirements."
China Aoxing has also licensed the rights to the China market for
MoxDuo®IR, an immediate release capsule presently in pivotal Phase 3
studies in the United States. A binding term sheet has been signed by the
parties and the transaction is expected to be closed by the end of March
2010.
"We are excited to enter into this strategic alliance with QRxPharma to
co-develop two promising drugs for China and ex-China markets," said
Zhenjiang Yue, the CEO and Chairman of China Aoxing. "This partnership
further solidifies China Aoxing's leading position in the rapidly growing
narcotics and pain management market in China. It also bolsters our
capability to develop and bring to market innovative, high-value medicines
that have the potential to address significant unmet medical needs. We
believe that the partnership will generate significant opportunities and
benefits for both companies."
In July 2009, QRxPharma announced the initiation of a comparative
proof-of-concept study to evaluate the efficacy and safety of MoxDuo®IV
versus IV morphine alone for the treatment of moderate to severe
post-operative pain in patients following hip replacement surgery. Data
from this study, available in 2Q 2010, may serve as a significant predictor
of MoxDuo®IV's clinical benefits and provide guidance for the design of
clinical trials with China Aoxing which may be used to support any later
submission of a New Drug Application (NDA) with the FDA.
MoxDuo®IV is one of three complementary Dual-Opioid™ products in
development. MoxDuo®IR, an immediate-release oral formulation, is in
pivotal Phase 3 trials and clinical studies for a controlled-release oral
formulation will be initiated in the near future. Extensive clinical
studies have demonstrated QRxPharma's Dual-Opioids™ provide as good or
better pain relief with significantly fewer side effects, giving doctors
and patients more options in the treatment of moderate to severe pain from
the hospital to the home.
Forward-Looking Statements from QRxPharma Limited
This release contains forward-looking statements. Forward-looking
statements are statements that are not historical facts; they include
statements about our beliefs and expectations. Any statement in this
release that states our intentions, beliefs, expectations or predictions
(and the assumptions underlying them) is a forward-looking statement.
These statements are based on plans, estimates and projections as they are
currently available to the management of QRxPharma. Forward-looking
statements therefore speak only as of the date they are made, and we
undertake no obligation to update publicly any of them in light of new
information or future events. By their very nature, forward-looking
statements involve risks and uncertainties. A number of important factors
could therefore cause actual results to differ materially from those
contained in any forward-looking statement. Such factors include risks
relating to the stage of products under development; uncertainties relating
to clinical trials; dependence on third parties; future capital needs; and
risks relating to the commercialisation of the Company's proposed products.
Safe Harbor Statement from China Aoxing Pharmaceutical Company, Inc
Statements made in this press release are forward-looking and are made
pursuant to the safe harbor provisions of the Securities Litigation Reform
Act of 1995. Such statements involve risks and uncertainties that may
cause actual results to differ materially from those set forth in these
statements. The economic, competitive, governmental, technological and
other risk factors identified in the Company's filings with the Securities
and Exchange Commission, including the Form 10-K for the year ended June
30, 2009, may cause actual results or events to differ materially from
those described in the forward looking statements in this press release.
The Company undertakes no obligation to publicly update or revise any
forward-looking statements, whether because of new information, future
events, or otherwise.
About QRxPharma
QRxPharma is a clinical-stage specialty pharmaceutical company focused on
the development and commercialisation of therapies for pain management and
central nervous system (CNS) disorders. Based on a business strategy to
expand the clinical utility and commercial value of marketed and/or
existing compounds, QRxPharma's product portfolio includes both late and
early stage clinical drug candidates with
well-defined paths to regulatory approval and sales. The Company intends to
directly commercialise its products in the US and seek strategic
partnerships for worldwide markets. QRxPharma's lead compound, MoxDuo®IR
(Q8003IR), is in Phase 3 clinical development and has successfully
completed multiple comparative studies evaluating its efficacy and safety
against equianalgesic doses of morphine, oxycodone and Percocet® for the
treatment of acute pain. Study results consistently demonstrate
MoxDuo®IR's greater overall tolerability, achieving as good or better pain
relief with substantially fewer incidences of moderate to severe side
effects. The Company's preclinical and clinical pipeline includes other
technologies in the fields of pain management, neurodegenerative disease
and venomics. For more information: www.QRxPharma.com.
About China Aoxing
China Aoxing is a US incorporated specialty pharmaceutical company with its
main operations in China, specializing in research, development,
manufacturing and distribution of a variety of narcotics and
pain-management products. Headquartered in Shijiazhuang City, outside
Beijing, China Aoxing has the largest and most advanced manufacturing
facility for highly regulated narcotic medicines. Its facility is one of
the few GMP facilities licensed for the manufacture of narcotic medicines
by the China State Food and Drug Administration (SFDA). It has a strategic
alliance with American Oriental Bioengineering, Inc. (NYSE: AOB). For more
information: www.chinapainmed.com.
