WuXi subsidiary in deal with Pharmacyclics
Supply arrangement follows approval of Imbruvica by US FDA
Shanghai SynTheAll Pharmaceutical, a subsidiary of WuXi PharmaTech, a pharmaceutical, biotechnology and medical device research and development outsourcing company with operations in China and the US, has entered into a supply arrangement with US-based Pharmacyclics. The deal follows a multi-year development and clinical manufacturing partnership that supported Pharmacyclics, with the expedited New Drug Application (NDA) submission and final approval by the US Food and Drug Administration (FDA).
After an expedited review by the FDA, Imbruvica received approval on 13 November 2013 for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy.
'It is important that we work with a development partner with expertise in both clinical and commercial supply, as well as US and worldwide GMP regulations, to ensure reliable quality supply to patients,' said Heow Tan, Chief of Technical Operations at Pharmacyclics.
