NEW YORK, NY--(Marketwire - January 25, 2010) -
China Aoxing Pharmaceutical Company, Inc.
) ("China Aoxing"), a pharmaceutical company specializing in
research, development, manufacturing and distribution of narcotic and
pain-management products, today announced that it completed Phase III
clinical study for Tilidine tablets, a novel drug in China to treat acute
and chronic moderate to severe pain, including post-operative and cancer
pain in adult patients. The drug is designated as a Class III New Medicine
with approximately at least four-year market exclusivity protection upon
marketing clearance by the China SFDA.
"Reaching this pivotal milestone is an important event for the development
of our Tilidine franchise, and will enable a complete analysis of the trial
results and a timely submission of new drug application (NDA) to the China
SFDA. We believe that Tilidine has the potential to become a major player
in the underserved pain market in China," said Mr. Zhenjiang Yue, CEO and
Chairman of China Aoxing. "Also, we are looking forward to reporting the
top-line results in the coming weeks."
The Phase III clinical study was a multi-center, randomized, double-blind
and active-control study which covers two pivotal trials, (1) a trial of
200 patients with post-operative pain for the indication of acute moderate
to severe pain; (2) a trial of 120 patients with cancer pain for the
indication of chronic moderate to severe pain. The study was conducted at
9 metropolitan hospitals in China. The primary endpoints used to evaluate
the efficacy were the sum of pain score differences, measured by Pain
Intensity Difference (PID). The size of the trials per protocol was not
powered to achieve statistical significance between the treatment arms
versus control arms.
In China it is estimated that there are at least 50 million operation
procedures performed in hospital and clinical centers every year, and 50%
of these procedures require acute post-operative pain treatment. On the
other hand there are estimated to be over 2.2 million newly diagnosed
cancer patients every year, and 60% of them are unable to receive necessary
pain management under current treatment paradigm. Cancer has become the No.
1 cause and attribute to 20% of adult death in China based on the New
England Journal of Medicine.
Tilidine hydrochloride is an orally-absorbed synthetic narcotic analgesic
in 50mg or 100mg dosage strength for relief of acute, moderate to severe
pain, and chronic cancer-related pain. It is mainly used in European
countries, including Germany, Belgium, Ireland, Italy, Switzerland, and etc.
It is not available in China at the moment.
Based on the Annual Report of International Narcotics Control Board in 2008,
global consumption reached a record level in 2007 and global Tilidine
manufacture also reached a peak of 62.2 tons in 2007, twice the level
reported in 2002, or at CAGR of 15% during the last five year period.
About China Aoxing Pharmaceutical Company, Inc.
China Aoxing Pharmaceutical Company, Inc. (OTCBB: CAXG) is a pharmaceutical
company specializing in research, development, manufacturing and
distribution of a variety of narcotics and pain-management products. It has
a strategic alliance with American Oriental Bioengineering, Inc. (NYSE: AOB). Headquartered in Shijiazhuang City, the pharmaceutical capital of
China, outside of Beijing, China Aoxing has China's largest and the most
advanced manufacturing facility for highly regulated narcotic medicines,
addressing a very under-served and fast-growing market in China. Its
facility is one of the few GMP facilities licensed for narcotics medicines.
The Company is working closely with the Chinese government and SFDA to
assure the strictly regulated availability to medical professionals of its
narcotic drugs and pain medicines throughout China.
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.