DALLAS & FORT WORTH, Texas--(BUSINESS WIRE)--Neos Therapeutics, Inc. (“Neos”), a specialty pharmaceutical company with a portfolio of novel and proprietary oral drug delivery technologies as well as a late-stage pipeline of innovative extended release (“XR”) products for Attention Deficit Hyperactivity Disorder (“ADHD”), announced today that is has settled all pending litigation with Shire LLC (“Shire”) in connection with Neos’ amphetamine polistirex orally disintegrating tablet known as NT-0202 for the treatment of ADHD. NT-0202 is positioned to be the first-ever, extended release orally disintegrating tablet (“XR-ODT”) dosage form of amphetamine for the treatment of ADHD.
The litigation involved a patent infringement lawsuit brought by Shire under the Hatch-Waxman Act framework stemming from Neos’s filing of its New Drug Application under section 505(b)(2) of the Federal Food, Drug, and Cosmetics Act for NT-0202 with the United States Food and Drug Administration (“FDA”). On April 11, 2013, Shire filed suit against Neos asserting that Neos infringed U.S. Patent No. RE 42,096 and U.S. Patent No. 41,148 (collectively, the “Patents”).
The parties have entered into a License Agreement which provides Neos with a license to the Patents and U.S. Patent No. 6,913,768, to make, market and sell NT-0202. Neos will pay Shire a royalty from the sales of NT-0202 until the expiration of the patents.
Vipin K. Garg, Ph.D., President and CEO of Neos, stated, “We are very pleased to have reached this settlement with Shire. Neos will continue to pursue FDA approval of NT-0202 without further risk of delay due to this litigation.”
About Neos Therapeutics
Neos Therapeutics, Inc. is a fully integrated specialty pharmaceutical company. The Company is initially focusing on ADHD with three proprietary products in late-stage development that provide patient-friendly dosage forms incorporating controlled and extended release oral disintegrating tablets (ODT) and liquid suspensions. In addition, Neos manufactures and markets a Generic of Tussionex®, for the treatment of cough and cold. The Company’s products are developed and manufactured using its proprietary and patented ion resin technology. For more information, visit www.neostx.com.
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.
Contacts
Neos Therapeutics
Vipin K. Garg, Ph.D.
President and CEO
(919) 434-6643
vgarg@neostx.com
or
Richard E. Eisenstadt
Chief Financial Officer
(972) 408-1389
reisenstadt@neostx.com
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