Shanghai SynTheAll (STA) Pharmaceutical Co., Ltd., WuXi’s STA, WuXi’s wholly owned subsidiary of small molecule process R&D and manufacturing division, 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’ IMBRUVICA, with the expedited New Drug Application submission and final approval by the U.S. Food & Drug Administration (FDA). 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. More.