Regis Technologies Passes FDA Pre-Approval Inspection for Acorda Therapeutics' Approved Multiple Sclerosis Drug, Ampyra
Morton Grove, Illinois (January 28, 2010) -- Regis Technologies, Inc. , a leading provider of cGMP and non-GMP synthesis and separations services for active pharmaceutical ingredients (APIs) and intermediates, announced it has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) stating that Regis passed the FDA's pre-approval inspection (PAI) for its manufacture of 4-Aminopyridine the active ingredient in AmpyraTM .
Acorda Therapeutics' drug, AmpyraTM, was approved by the FDA on January 22, 2010, as a treatment to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed. The FDA inspected Regis's facility for seven days in April and May 2009. The EIR and PAI approval was issued in November, 2009.
"We are thrilled to see AmpyraTM receive FDA approval as a treatment that may help the many people with MS with walking impairment. Regis is proud to partner with Acorda and looks forward to continuing collaborations in the development of life-changing therapeutics," said Louis Glunz IV, president of Regis Technologies.
Ampyra TM is an oral, sustained-release tablet formulation of 4-aminopyridine, which in laboratory studies has been found to improve impulse conduction in nerve fibers where the insulating layer, called myelin, has been damaged. Regis initially developed the synthesis for 4-aminopyridine more than 25 years ago, when the compound was first investigated at Rush's Hospital in Chicago. It currently holds the U.S. and several foreign drug master files (DMFs) for this compound.
Regis Technologies, which increased its facility to 51,000 square feet in 2009, also passed its general inspection by the FDA, conducted during the same period as the pre-approval inspection.
About Regis Technologies, Inc.
Regis Technologies, a privately held company founded in 1956, helps biotechnology and pharmaceutical companies expedite their drugs to market. Our cGMP and non-GMP synthesis and separations services advance active pharmaceutical ingredients (APIs) and intermediates from initial process development and scale-up to final validation and commercial manufacturing. We are a leading manufacturer of chromatography products and services, especially those with a chiral emphasis.
Contacts:
Sean F. Bradley
Director of Business Development
847-583-7631.
Debra Harrsch
Brandwidth Solutions LLC
215-997-8575
[email protected]
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