WuXi PharmaTech's subsidiary, Shanghai SynTheAll (STA) Pharmaceutical Co., has entered into a supply agreement with Pharmacyclics, Inc. This follows a successful development and clinical manufacturing partnership for Pharmacyclics expedited NDA and FDA approval for Imbruvica for the treatment of patients with mantle cell lymphoma. The FDA conducted a GMP pre-approval inspection of WuXi's manufacturing facilities in August, with no Form 483 observations.
Imbruvica is an oral therapy that inhibits a protein called Bruton's tyrosine kinase (BTK), a key signaling molecule 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.
"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," said 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."
"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 chief executive officer of WuXi. "WuXi is determined to help our partners introduce innovative breakthrough drugs like Imbruvica to benefit patients around the world."