China Aoxing Pharmaceutical Company Announces Successful Completion of Phase III Registration Clinical Study of Tilidine for Mod
26 January 2010 - 12:30AM
Marketwired
China Aoxing Pharmaceutical Company, Inc. (OTCBB: CAXG) ("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.
About Tilidine
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.
Contact: Wei Zhang Vice President China Aoxing Pharmaceutical
Company, Inc. Email: chinaaoxing@gmail.com Telephone: 646 -
367-1747 Website: www.chinapainmed.com
American Oriental Bioengineering, Inc. (NYSE:AOB)
Historical Stock Chart
From Jun 2024 to Jul 2024
American Oriental Bioengineering, Inc. (NYSE:AOB)
Historical Stock Chart
From Jul 2023 to Jul 2024