Riverview, Michigan, June 10, 2013 – Ash Stevens, Inc. (ASI), a leading provider of global contract pharmaceutical drug substance development and API (Active Pharmaceutical Ingredient) manufacturing services, announces the U.S. Food and Drug Administration (FDA) has approved ASI's manufacturing facility in Riverview, Michigan for the manufacture of the API in ARIAD Pharmaceuticals, Inc.'s (NASDAQ: ARIA) recently approved oncology drug Iclusig® (ponatinib). The drug was granted accelerated approval on December 14, 2012 by the FDA for the treatment of adult patients with chronic, accelerated or blast phase chronic myeloid leukemia (CML) that is resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) that is resistant or intolerant to prior TKI therapy.
“We are very proud to be ARIAD Pharmaceuticals’ outsourcing partner for the development and manufacture of this important API. We have a collaborative and highly productive relationship with ARIAD and we are excited to help provide this innovative therapy to cancer patients,” says Dr. Stephen A. Munk, President and CEO of Ash Stevens, Inc.
ASI has a rich history of developing and manufacturing cancer therapeutics going back over 50 years. Ponatinib is ASI's twelfth manufacturing approval for an innovator or NCE (New Chemical Entity) drug and the company's fourth FDA accelerated approval. The Pre-Approval Inspection (PAI) did not generate a FDA-483 citation and was a special achievement for Ash Stevens as it incorporated elements of “Quality by Design” or QbD. An ICH (International Conference on Harmonization) guidance encourages a QbD approach to API manufacturing. QbD is a scientific approach based on statistical methods enabling an enhanced understanding of safety and control of chemical drug manufacturing processes. QbD is designed to yield more robust manufacturing processes than that which can be achieved by traditional approaches to drug development.