RIVERVIEW, MI -- (Marketwired) -- 06/11/13 -- 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.
About Ash Stevens, Inc. Ash Stevens, Inc. (ASI) is a full service Contract Pharmaceutical Manufacturer offering comprehensive small-molecule drug substance development and cGMP manufacturing services. Founded in 1962 and headquartered in Riverview, Michigan, ASI has extensive experience developing and manufacturing Active Pharmaceutical Ingredients (APIs) for commercial clients in the Life Sciences industry developing innovator small-molecule therapeutics. ASI is a longtime provider of contract research services to the National Institutes of Health and the National Cancer Institute, and has participated in the development of many important drugs through these government agencies. To date, ASI has received twelve FDA manufacturing approvals for innovator APIs, including four Fast Track manufacturing approvals for the active ingredients in the oncology drugs Velcade®, Vidaza®, Clolar® and Iclusig®. Services offered by Ash Stevens include: process development and scale-up; cGMP manufacturing; development and cGMP manufacture of highly potent APIs using barrier-isolation technology; comprehensive analytical capabilities (including method development, stability studies and qualification of reference standards); and regulatory support for all phases of drug development and manufacturing. For more information, visit www.ashstevens.com or contact Dr. James Hamby, Vice President of Business Development (firstname.lastname@example.org).
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