ICON plc, (NASDAQ: ICLR; ISIN:IE0005711209), a global provider of
outsourced development services to the pharmaceutical, biotechnology and
medical device industries, today announced that it has been selected by
Tasly Pharmaceuticals ( 600535, SH)for the company’s global Phase III
T89 trial. T89, also known as Dantonic® pill, aims to become the first
traditional Chinese medicine to receive FDA approval in the United
States.
Dantonic® pill is a botanical product for the treatment of chronic
stable angina pectoris due to coronary heart disease. It is a modernised
version of a traditional Chinese herbal medicine and was approved by the
State Food and Drug Administration (SFDA) of China in 1993. Since then,
more than 2 billion doses have been used by over 10 million patients.
Tasly Pharmaceuticals Inc., the fully-owned subsidiary of China based Tasly Pharmaceuticals Co. Ltd., a public company, is
conducting two global Phase III trials for the Dantonic® pill. Icon has
been awarded the 3-arm Phase III clinical trial and will also be
providing IVRS, data management and central laboratory services for both
global trials.
"Dantonic® pill global Phase III studies are pioneering projects. There
are a number of innovative components in the R&D of this drug,”
commented Dr. Henry Sun, President of Tasly Pharmaceuticals, Inc., and
Vice President of Tasly Group. "When choosing a CRO for these important
Phase III trials we sought a company that had a large global
infrastructure supported by the most advanced regional testing
facilities. In ICON we have found a trusted development partner with all
of these attributes and one that also has a strong reputation for
delivering quality clinical programs.”
"ICON is proud to play an important role in helping advance the
globalisation of traditional Chinese medicine,” commented Dr. Malcolm
Burgess, Executive Vice President, ICON Clinical Research. "Through our
experience of managing studies in all major geographies, we have
established solid working relationships with the world’s leading
investigators and our regional testing facilities are strategically
located to support global trials. We look forward to working with Tasly
and to helping them in their efforts to become the first provider of an
FDA-approved traditional Chinese medicine.”
About Tasly pharmaceuticals Co. Ltd.
Tasly pharmaceutical Co. Ltd.,
based in Tianjin, China, was founded in May 1994. Through its
development, Tasly has become a high-tech group whose scope of
businesses includes modern TCMs, chemical & biological drugs, healthcare
products and functional foods. The Company has a large research
institute and oversees its own product development, planting,
manufacturing, commercial sales and distribution. Tasly manufactures and
sells its traditional Chinese medicines, generic drugs, vaccines and
personal care products in China and in several other countries around
the world. Tasly entered a drug-wholesaling venture with the UK’s
Co-operative Group in 2007. For more information about the Company,
please visit www.tasly.com.
About ICON plc
ICON plc is a global provider of outsourced
development services to the pharmaceutical, biotechnology and medical
device industries. The Company specialises in the strategic development,
management and analysis of programs that support clinical development -
from compound selection to Phase I-IV clinical studies. ICON currently
has around 8,300 employees, operating from 79 locations in 38 countries.
Further information is available at www.iconplc.com
