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Ash Stevens to Manufacture Ponatinib API

Ash Stevens to Manufacture Ponatinib API 
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(R) (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 headquartere
d 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(R), Vidaza(R), Clolar(R) and Iclusig(R). 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 (jhamby@ashstevens.com). 
Contact: 
Alan Zachary 
Harris D. McKinney 
(312) 506-5220 
(708) 707-6834 - mobile 
azachary@harrisdmckinney.com 
 
 
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