Nov. 15, 2013
/PRNewswire/ -- WuXi PharmaTech (NYSE: WX), a leading pharmaceutical, biotechnology and medical device research and development outsourcing company with operations in
the United States
, today announced that its wholly owned subsidiary Shanghai SynTheAll (STA) Pharmaceutical Co., Ltd., has entered into a supply arrangement with 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
"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 IMBRUVICA."