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."
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