Neos Therapeutics Announces Settlement with Teva on Cotempla XR-ODT® Patent Litigation
December 26 2018 - 7:30AM
Neos Therapeutics, Inc. (Nasdaq:NEOS), a pharmaceutical company
focused on developing, manufacturing, and commercializing
innovative extended-release (XR) products using its proprietary
modified-release drug delivery and orally disintegrating tablet
(ODT) technology platforms, today announced that it has entered
into a confidential settlement and licensing agreement with Teva
Pharmaceuticals USA, Inc. (“Teva”) to resolve all ongoing
litigation involving Neos' patents protecting its Cotempla XR-ODT®
(methylphenidate) extended-release orally disintegrating tablets
and Teva's Abbreviated New Drug Application (ANDA) filed with the
U.S. Food and Drug Administration to market a generic version of
that product.
Under the settlement and license agreement, Neos
has granted Teva the right to manufacture and market its generic
version of Cotempla XR-ODT® under the Teva ANDA beginning on July
1, 2026, or earlier under certain circumstances.
The settlement and licensing agreement is
confidential and the agreement is subject to submission to the
Federal Trade Commission and the U.S. Department of Justice.
“We are pleased to have reached this settlement
and will continue to defend our innovative medicines against any
challenge,” said Jerry McLaughlin, Chief Executive Officer of Neos
Therapeutics.
About Neos Therapeutics
Neos Therapeutics, Inc. (NASDAQ: NEOS) is a
pharmaceutical company focused on developing, manufacturing and
commercializing products utilizing its proprietary modified-release
drug delivery technology platforms. Adzenys XR-ODT® (amphetamine)
extended-release orally disintegrating tablets (see Full
Prescribing Information, including Boxed WARNING), Cotempla XR-ODT®
(methylphenidate) extended-release orally disintegrating tablets
(see Full Prescribing Information, including Boxed WARNING), and
Adzenys-ER™ (amphetamine) extended-release oral suspension (see
Full Prescribing Information, including Boxed WARNING), all for the
treatment of ADHD, are three approved products using the Company’s
extended-release technology platform. Additional information
about Neos is available at www.neostx.com.
Forward-Looking Statements
Any statements in this press release about
future expectations, plans and prospects for Neos
Therapeutics, Inc., including statements about Neos’ future
expectations and plans to defend and enforce its intellectual
property rights and other statements containing the words “will,”
“would,” “continue,” and similar expressions, constitute
forward-looking statements within the meaning of The Private
Securities Litigation Reform Act of 1995. Actual results may differ
materially from those indicated by such forward-looking statements
as a result of various important factors, including: the
uncertainties related to governmental approvals of the settlement
and license agreement, Neos’ ability to protect its intellectual
property rights, uncertainties related to litigation Neos is
involved or may become involved, uncertainties inherent in the
initiation of future clinical trials, expectations of expanding
ongoing clinical trials and other factors discussed in the “Risk
Factors” section in our most recently filed Annual Report on
Form 10-K for the year ended December 31, 2017, which is
on file with the SEC, as updated by any subsequently filed SEC
filings, including Neos’ Quarterly Reports on Form 10-Q. Any
forward-looking statements contained in this press release speak
only as of the date hereof, and Neos expressly disclaims any
obligation to update any forward-looking statements, whether as a
result of new information, future events or otherwise.
CONTACTS:
Richard I.
Eisenstadt
Chief Financial
Officer
Neos
Therapeutics
(972)
408-1389
reisenstadt@neostx.com
Sarah McCabe and Carl MauchInvestor Relations
Stern Investor Relations, Inc. (212) 362-1200 sarah@sternir.com and
carl@sternir.com
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