QRxPharma Limited and China Aoxing Pharmaceutical Company Announce Strategic Alliance for Development of MoxDuo(R)IV
24 February 2010 - 12:00AM
Marketwired
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.
For more information please contact: QRxPharma Ltd John Holaday,
Ph.D Managing Director and Chief Executive Officer Tel: +1 301 908
3086 Email: john.holaday@qrxpharma.com Chris J Campbell Chief
Financial Officer and Company Secretary Tel: +61 2 9492 8021 Email:
chris.campbell@qrxpharma.com China Aoxing Pharmaceutical Company
Investor Relations Contact: Brian Korb Vice President The Troup
Group LLC Tel: +1 646 378 2923 Email: bkorb@troutgroup.com
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