Ash Stevens was approved to manufacture the bulk drug substance Clofarabine, the active ingredient in Genzyme Corp.'s Clolar (clofarabine) for the treatment of children with refractory or relapsed Acute Lymphoblastic Leukemia (ALL). This is the first new leukemia treatment approved specifically for children in more than a decade.
"Clofarabine is a new drug giving hope to those suffering from certain forms of leukemia and requiring salvage therapy," said Dr. Stephen Munk, CEO and President of Ash Stevens. "Approval to manufacture this drug is especially rewarding as it provides hope for children suffering from a fatal condition."
Clofarabine will be manufactured in ASI's renovated Riverview, Mich., manufacturing facility immediately. The 30,000 square foot state-of-the-art facility includes reaction vessels with capacities up to 500 gallons and a variety of product isolator systems including a Walker-Carlisle containment isolator for high potency drug substances.
"This is Ash Stevens' third approval to manufacture a novel, New Chemical Entity from the FDA in under two years and is a remarkable achievement for any company," said Munk. "It is noteworthy that our quality and regulatory professionals gained three very rapid regulatory approvals to market those products though hard work with our clients. The tight timelines that we meet on a regular basis ensures our clients' rapid access to the market."
Headquartered in Detroit, Ash Stevens Inc. is an established pharmaceutical contractor that develops, registers and manufactures Active Pharmaceutical Ingredients. Founded in 1962 to service the Federal Government's chemical research needs, ASI has a long-standing research arrangement with the National Cancer Institute. ASI has 60 employees and holds a variety of patents covering topics including medicinal agents and manufacturing processes.