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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 Ampyra™.

Acorda Therapeutics’ drug, Ampyra™, 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 Ampyra™ 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 ™ 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.
sbradley@registech.com

Regis Technologies Hires Additional Scientists

MORTON GROVE, Ill.--(BUSINESS WIRE)--Regis Technologies, Inc., a leading provider of cGMP and non-GMP synthesis and separations services for active pharmaceutical ingredients that help expedite drugs to market, announced today that it has expanded its scientific staff with the addition of four scientists formerly employed by deCODE genetics Inc., which filed this month for Chapter 11 protection in U.S. Bankruptcy Court.

Joining Regis as a lead NMR specialist is Nelson Zhao, PhD Biochemistry. Igor Likhotvorik, PhD Chemistry, Siead Zegar, BS Chemistry, and Dragan Ristic, BS Engineering, all of deCODE’s development and production staff, are also joining Regis’s staff.

“Regis Technologies has always believed that our employees are our core strength, and to be able to add these scientists to our staff is a tremendous opportunity for us and for our customers,” said Louis Glunz IV, president of Regis. “These hires fit strategically with our plan for growth and enhanced customer services.”

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, and our SFC separation services offers analysis and purification of chiral separations. Additionally, we manufacture high purity, fine organic chemicals. Our facility, now 51,000-square feet, has been fully GMP compliant since 1993. For more information, visit www.registech.com.

Regis is seeking Partners with Viracol, an anti-viral drug candidate

Regis Technologies is seeking partners to share in the development and marketing of Viracol formulations, which have shown efficacy against cold sores, genital herpes, and varicella zoster virus (shingles).  Viracol was developed by Dr. Anthony Verbiscar at Anver Pharmaceutical Co.  Several domestic and international patents are involved.  Regis, the chemical producer of medical grade jojoba alcohol, is pursuing this technology on behalf of the Verbiscar family since the untimely death of Dr. Verbiscar. 

Regis Completes New Quality Control Laboratory

Regis is proud to announce the opening of their new Analytical Development and Quality Control laboratories.  The expansion at the existing site adds 8,000 square feet of new laboratory space, and includes a 400 MHz Bruker NMR.  These new laboratories will allow us to better serve our customers by providing the most up-to-date technology in a 1st rate facility. 

Regis Technologies, Inc. Introduces RegisPack™ Polysaccharide Coated Chiral Columns

Gives Chiral Chromatographers an Affordable Choice for First Time

Morton Grove, Illinois — November 12, 2007.

Regis Technologies, Inc., a leader in chiral separations serving the analytical and preparative needs of chromatographers worldwide, introduces RegisPack™ ― a new and improved polysaccharide coated chiral column for enantiomeric separations of a wide range of racemate classes. Chiral chromatographers in the pharmaceutical and biotechnology industry now have an affordable choice for the separations using the tris-(3,5-dimethylphenyl) carbamoyl amylose selector.

The RegisPack™ introduction represents the second in a line of affordable polysaccharide coated chiral column from Regis. The company introduced the RegisCell™ columns with a tris-(3,5-dimethylphenyl) carbamoyl cellulose selector in June 2007.

RegisPack™ columns feature excellent selectivity and high theoretical plate count for superior resolution. The columns’ high pressure limit (450 bar) delivers fast method development, run times, and equilibration times without sacrificing resolution or performance. RegisPack™ columns can be used for SFC and HPLC analyses, and are the same price.

RegisPack™ columns are available in 5, 10, and 20 micron particle sizes enabling easily scale up from analytical to preparation. Bulk material and 20-micron columns are available upon request. Regis Technologies offers free chiral screening on its proprietary phases.

About Regis Technologies, Inc.

Regis Technologies, Inc. is a privately held company that provides synthesis and separations services to the pharmaceutical, biotechnology, diagnostic, and other industries. Regis partners with these organizations to provide synthesis services including methods development, scale-up, and manufacture of complex, multi-step custom synthetic products. Regis provides innovative chromatography products and services, especially those with a chiral emphasis, through the utilization of our extensive organic expertise and its collegiate collaborations.

Regis Technologies, Inc. Introduces RegisCell™ Polysaccharide Coated Chiral Columns

Chiral Chromatographers Have an Affordable Choice for First Time

Morton Grove, Illinois — July 5, 2007.

Regis Technologies, Inc., a leader in chiral separations serving the analytical and preparative needs of chromatographers worldwide, introduces RegisCell™ ― a new and improved polysaccharide coated chiral column for enantiomeric separations of a wide range of racemate classes. Chiral chromatographers in the pharmaceutical and biotechnology industry now have an affordable choice for the separations using the tris-(3,5-dimethylphenyl) carbamoyl cellulose selector.

RegisCell™ columns feature excellent selectivity and high theoretical plate count for superior resolution. The columns’ high pressure limit (450 bars) delivers fast method development, run times, and equilibration times without sacrificing resolution or performance. RegisCell columns can be used for SFC and HPLC analyses, and are the same price.

RegisCell™ columns are available in 5, 10, and 20 micron particle sizes enabling easily scale up from analytical to preparation. Bulk material and 20-micron columns are available upon request. Regis Technologies offers free chiral screening on its proprietary phases.

About Regis Technologies, Inc.

Regis Technologies, Inc. is a privately held company that provides synthesis and separations services to the pharmaceutical, biotechnology, diagnostic, and other industries. Regis partners with these organizations to provide synthesis services including methods development, scale-up, and manufacture of complex, multi-step custom synthetic products. Regis provides innovative chromatography products and services, especially those with a chiral emphasis, through the utilization of our extensive organic expertise and its collegiate collaborations.

Regis Technologies, Inc. Celebrates 50th Anniversary

Built Worldwide Reputation for Excellence in Custom Synthesis and Chromatography Products

Morton Grove, Illinois November 2, 2006 -

Regis Technologies, Inc. today announced that the company is celebrating its 50th anniversary. Since its opening in 1956, Regis has earned a worldwide reputation for excellence in chromatography products and its capability to synthesize complex molecules for the pharmaceutical industry. Few companies can claim this long standing history of success and innovation while continuing to grow into the future. In the midst of this milestone anniversary, the company is also celebrating expansion with a new facility and the introduction of new services.

As an innovator, Regis initially concentrated on custom synthetic chemistry for the emerging field of psychopharmacology. Later it moved into gas and liquid chromatography, and more recently developed expertise in synthesizing drugs for all stages of drug development. Today, Regis serves startup biotechnology companies and large, multinational pharmaceutical corporations helping to expedite new drugs to market.

Regis Technologies, Inc. continues to enjoy growth by providing expanded services for drug development, including process research, analytical method development, scale-up, validation, stability studies, and commercialization. Additionally, we are expanding our chromatographic separation capability by adding Supercritical Fluid Chromatography (SFC), an environmentally friendly technology. Now, with a dedicated staff and a new Synthetic Research Laboratory wing, Regis continues to broaden its capacity to serve the pharmaceutical industry.

The privately held company is family owned and operated. Regis Chairman Louis J. Glunz III, Ph.D. reflects on values and principles that his grandfather Louis Glunz I held when he started his first enterprise in the late 1800s-innovation, customer service, quality, and a commitment to community. The values and principles became the cornerstone of Regis Technologies when it first opened its doors to business in 1956. These values and principles remain alive today.

"While celebrating a half-century as chemists to the life sciences," says Regis Chairman Louis J Glunz III, Ph.D., "we're grateful for the trust and loyalty of our customers, employees, and friends. Going forward, be assured that Regis will continue to invest and remains committed to enhancing the quality of life for all."

About Regis Technologies, Inc.

Regis Technologies, Inc. is a privately held company that provides synthesis and separations services to the pharmaceutical, biotechnology, diagnostic, and other industries. Regis partners with these organizations to provide synthesis services including methods development, scale-up, and manufacture of complex, multi-step custom synthetic products. Regis provides innovative chromatography products and services, especially those with a chiral emphasis, through the utilization of our extensive organic expertise and its collegiate collaborations.

Regis Technologies Expands Its GMP-Approved Chiral Separations Services with SFC

Expands Expertise in Chiral Technology for Manufacturing and Drug Developers

Morton Grove, Illinois January 6, 2006 -

Regis Technologies, Inc. partners with pharmaceutical, biotechnology, and other companies to help expedite drugs to market by providing synthesis and separations services. Regis Technologies announced today it has added Supercritical Fluid Chromatography (SFC) to its separations services and will offer GMP separations April 1, 2007.

The new service marries SFC with the company's proven expertise chiral HPLC services and products. Regis Technologies has long fulfilled the analytical and preparative market needs with its quality chromatography products including their proprietary Chiral Stationary Phases. Being a fully compliant GMP organization since 1993, Regis will now offer SFC as a GMP stand-alone service or in concert with its GMP manufacturing.

Regis Technologies will use the Thar SFC Method Station® equipment with Regis and other chiral stationary phases, and have agreed to be a host demonstration partner for Thar systems. Regis chose the Thar system for its quality, service, and ability to validate ancillary systems.

"We are pleased to add SFC to our chiral separations services," says Sean F. Bradley, Regis Technologies Director of Business Development. "SFC is well-established as a method-of-choice for chiral separations. It enjoys advantages over traditional preparative HPLC separations such as shorter run times, less solvent consumption and less waste without sacrificing purity."

Potential pharmaceutical organizations that may benefit from this offering are: preclinical laboratories in need of small amounts of enantiomerically pure compounds, pharmaceutical companies producing phase I, II and III clinical candidates requiring enantiomeric separation, and labs isolating impurities.

Regis Technologies continues to improve and grow. In its third expansion in less than seven years, Regis has expanded its non-GMP development area to include 7,000 additional square feet of synthetic labs and offices.

About Regis Technologies, Inc.

Regis Technologies, Inc. is a privately held company that provides synthesis and separations services to the pharmaceutical, biotechnology, diagnostic, and other industries. Regis partners with these organizations to provide synthesis services including methods development, scale-up, and manufacture of complex, multi-step custom synthetic products. Regis provides innovative chromatography products and services, especially those with a chiral emphasis, through the utilization of our extensive organic expertise and its collegiate collaborations.

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