WuXi PharmaTech to Partner with Pharmacyclics
SHANGHAI, Nov. 15, 2013
SHANGHAI, Nov. 15, 2013 /PRNewswire/ -- WuXi PharmaTech (NYSE: WX), a leading
pharmaceutical, biotechnology and medical device research and development
outsourcing company with operations in China and the United States, today
announced that its wholly owned subsidiary Shanghai SynTheAll (STA)
Pharmaceutical Co., Ltd., has entered into a supply arrangementwith
Pharmacyclics, Inc. (Nasdaq: PCYC).This follows a successful multiple-year
development and clinical manufacturing partnership that supported
Pharmacyclics with the expedited New Drug Application submission and final
approval by the U.S. Food & Drug Administration (FDA).After an expedited
review by the FDA, IMBRUVICA received approval on November 13, 2013, for
treatment of patients with mantle cell lymphoma who have received at least one
prior therapy. This indication is based on overall response rate. An
improvement in survival or disease-related symptoms has not been established.
In the GMP pre-approval inspection of WuXi's manufacturing facilities in
August, no Form 483 observations were issued by the FDA.
IMBRUVICA is a first-in-class, oral therapy and is a new agent that inhibits a
protein called Bruton's tyrosine kinase (BTK). BTK is a key signaling
molecule of the B-cell receptor signaling complex that plays an important role
in the survival of malignant B cells. IMBRUVICA blocks signals that tell
malignant B cells to grow and divide uncontrollably. IMBRUVICA has been
granted three Breakthrough Therapy Designations by the FDA, a first for an
oncology drug. These designations are intended to expedite the development
and review of drugs for serious or life-threatening conditions. To date, nine
Phase III clinical trials have been initiated with IMBRUVICA and 37 clinical
trials are currently registered on www.clinicaltrials.gov.
"It is important that we work with a development partner with expertise in
both clinical and commercial supply, as well as U.S. and worldwide GMP
regulations, to ensure reliable quality supply to patients," commented Heow
Tan, Chief of Technical Operations at Pharmacyclics. "STA's extensive
experience will help us meet the demands of clinical and commercial supply for
"We are very pleased and honored that Pharmacyclics has selected STA, WuXi's
small-molecule development and manufacturing business unit, as a key partner
for this supply," said Dr. Ge Li, Chairman and CEO of WuXi. "WuXi is
determined to help our partners introduce innovative breakthrough drugs like
IMBRUVICA to benefit patients around the world."
About WuXi PharmaTech
WuXi PharmaTech is a leading pharmaceutical, biotechnology and medical device
R&D outsourcing company, with operations in China and the United States. As a
research-driven and customer-focused company, WuXi PharmaTech provides
pharmaceutical, biotechnology and medical device companies with a broad and
integrated portfolio of laboratory and manufacturing services throughout the
drug and medical device R&D process. WuXi PharmaTech's services are designed
to help its global partners in shortening the cycle and lowering the cost of
drug and medical device R&D. The operating subsidiaries of WuXi PharmaTech
are known as WuXi AppTec.
For more information, please contact:
Director of Investor Relations
Associate Director of Corporate Communications
SOURCE WuXi PharmaTech (Cayman) Inc.
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