Neos News & Events
- Neos Therapeutics, Inc. Announces the Appointment of Vipin K. Garg, Ph.D. as Chief Executive Officer and Board Director
Grand Prairie TX., October 22, 2013 (BUSINESS WIRE) – Neos Therapeutics, Inc. (Neos), a highly differentiated oral drug delivery company with an exciting portfolio of proprietary technologies and a pipeline of innovative controlled release (CR) products, announced today the appointment of Vipin K. Garg, Ph.D. to the role of Chief Executive Officer, effective immediately. Dr. Garg succeeds Neos Interim Chief Executive Officer, Alan Heller, who will continue serving as Chairman of the Neos Board of Directors. Dr. Garg will also serve as a member of the Neos Board of Directors.
Dr. Garg has over twenty-five years of experience within the biotechnology and pharmaceutical industries in both technical and management positions. He has a proven track record of building and managing both private and publicly traded companies. Before joining Neos Therapeutics, he served as President and Chief Executive Officer of Tranzyme Pharma (NASDAQ: TZYM), where he led the company’s initial public offering in 2011 and its merger with Ocera Therapeutics (NASDAQ: OCRX), Inc. in July, 2013.
Neos Therapeutics’ Chairman, Al Heller, stated, “I am excited to welcome Vipin to the Neos team. He brings to us a wealth of strategic, scientific and industry experience. Vipin will work closely with the organization to obtain FDA approval of our existing pipeline, and expand the use of our proprietary controlled release technologies to create additional CR orally disintegrating tablets and CR liquids to bring to market.”
Prior to joining Tranzyme, Dr. Garg served as Chief Operating Officer of Apex Bioscience, Inc. (now Curacyte AG of Munich, Germany), and held senior management positions at DNX Bio-Therapeutics, Inc. until its acquisition by Baxter Healthcare Corporation, Sunovion Pharmaceuticals, Inc. (formerly known as Sepracor Inc., now a subsidiary of Dainippon Sumitomo Pharma), and Bio-Response Inc. (acquired by Baxter Healthcare Corporation).
Dr. Garg received his Ph.D. in Biochemistry in 1982 from the University of Adelaide, Australia, and his M.S. from New Delhi, India in 1978. He was a member of the U.S. Presidential Mission to India led by President Bill Clinton in March, 2000. He is a past board member of the North Carolina Biotechnology Center and currently serves on the Executive Committee of CED (formerly the Council for Entrepreneurial Development). He was the recipient of the Ernst & Young Entrepreneur of the Year 2009 Award, Carolinas Region.
"I am delighted to join Neos Therapeutics," said Dr. Garg. "Neos has developed proprietary controlled release technologies. These technologies are being utilized to develop a pipeline of novel ADHD products which will advance significantly in the next 12-18 months. Building on the approval of a generic of Tussionex®, an extended release cough cold product developed utilizing the Neos technology and manufactured exclusively by Neos, the company is well positioned for growth. I look forward to working with the Neos team to expand the pipeline to additional opportunities including prescription, over-the-counter and veterinary products in a wide range of therapeutic areas.“
About Neos Therapeutics
Neos Therapeutics Inc. is a specialty pharmaceutical company focused on the development, manufacture and sale of FDA approved drug products that utilize the company’s proprietary delivery technologies. The Neos drug products are being developed using the Dynamic Time Release Suspension® (DTRS®) and Rapidly Disintegrating Ionic Masking™ (RDIM™) technologies that deliver controlled release (CR) small molecule active pharmaceutical ingredients (APIs) in either liquid or orally disintegrating tablet (ODT) dosage forms. By utilizing APIs that are FDA-approved and known to be safe and effective, Neos can reduce development and regulatory risk and efficiently advance targeted proprietary Rx products through the FDA’s New Drug Application (NDA) approval process. For more information, visit www.neostx.com.
Dynamic Time Release Suspension® and DTRS® are registered trademarks of Neos Therapeutics, LP, an affiliate of Neos Therapeutics, Inc., and Rapidly Disintegrating Ionic Masking™ and RDIM™ are trademarks of Neos Therapeutics, Inc.
This press release contains certain “forward-looking statements” that include projections and may also include words such as “may”, “will”, “expects”, “believes”, “anticipates”, “plans”, “estimates”, “seeks”, “could”, “intends”, and other similar expressions. These forward-looking statements involve risks, uncertainties, assumptions and other factors that are difficult to predict and that could cause actual results to vary materially from what is expressed in or indicated by the forward-looking statements.
Contact: Neos Therapeutics, Inc.
Ellen Hoffing, 847-597-1980
Co-President & COO
October 22, 2013
- FDA Accepts Neos Therapeutics’ NDA Filing for Extended Release Amphetamine Polistirex for the Once-Daily Treatment of ADHD
U.S. Food and Drug Administration (FDA) has accepted for review the company’s New Drug Application (NDA) 505(b)(2) filing for NT0202. The product is an Extended Release (XR) Orally Disintegrating Tablet (ODT) formulation of Amphetamine Polistirex developed for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
NT0202 is manufactured using Neos’ proprietary extended-release technology and Neos is seeking approval to both manufacture and market the product in the U.S. If approved, NT0202 will provide a novel extended release formulation alternative to currently available ADHD formulations. Neos believes that upon approval NT0202 would be the first once-daily, extended-release (XR) Orally Disintegrating Tablet (ODT) available for patients with ADHD. Not only children, but up to 40% of American adults have difficulty taking pills according to a Harris Interactive Survey. NT0202 will provide a convenient, easy to use dosage form that can be taken without water and is an option for patients of all ages who have difficulty, or don’t like to swallow pills.
Neos’ drug product is being developed using the Rapidly Disintegrating Ionic Masking™ (RDIM™) technology that delivers controlled-release (CR) small molecule APIs in an orally disintegrating tablet (ODT) dosage form.
March 13, 2013
- FDA Approves Cornerstone Therapeutics’ ANDA for Generic Tussionex® Pennkinetic® Product. Neos Therapeutics developed the drug product formulation using its proprietary formulation technology and will be the exclusive manufacturer.
U.S. Food and Drug Administration (FDA) approved its Abbreviated New Drug Application (ANDA) for a generic Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release suspension product. The antitussive/antihistamine combination product is a generic equivalent for the product currently sold under the Tussionex® Pennkinetic® brand name.
CRTX 067 was developed through a collaboration including Cornerstone, Coating Place, Inc. and Neos Therapeutics, LP, a subsidiary of Neos Therapeutics, Inc. Cornerstone will market the product through its wholly-owned generics subsidiary, Aristos Pharmaceuticals, Inc. Coating Place manufactures and supplies the active pharmaceutical ingredients (APIs), including a patent-protected version of hydrocodone polistirex. Neos developed the CRTX 067 drug product formulation using its proprietary formulation technology, Dynamic Time Release Suspension® (DTRS®), and Neos will be the exclusive manufacturer of the approved drug product.
July 2, 2012