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DALLAS/FORT WORTH, Texas, Nov. 17, 2016 -- Neos Therapeutics, Inc. (NASDAQ:NEOS), a pharmaceutical company focused on developing and commercializing innovative extended-release (XR) products for the treatment of attention-deficit hyperactivity disorder (ADHD), announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its Amphetamine XR oral suspension drug candidate, NT-0201, an ADHD medication based on its proprietary modified‐release drug delivery technology platforms.
“This NDA submission for NT-0201 is another important milestone for our company, as we continue to build out our ADHD product portfolio,” said Vipin K. Garg, Ph.D., President and CEO of Neos Therapeutics. “Additionally, we expect to resubmit the NDA for Cotempla XR-ODT™, our methylphenidate extended-release orally disintegrating tablet, this quarter. By the fall of 2017, with NT-0201 and Cotempla XR-ODT, if approved, and our already marketed product, Adzenys XR-ODT, we hope to offer patient-friendly treatment options for both of the stimulant medications that are most widely prescribed for the treatment of ADHD.”
NT-0201 is the company’s second extended-release amphetamine product candidate for the treatment of ADHD. The first, an extended-release orally disintegrating tablet, Adzenys XR-ODTTM, was approved by the FDA in January and was launched in May 2016. NT-0201 is a once-daily, extended-release liquid medication that does not require refrigeration or reconstitution at the pharmacy level. If approved, NT-0201 is designed to provide an additional treatment option for patients with ADHD.
About Neos Therapeutics
Neos Therapeutics, Inc. is a pharmaceutical company focused on developing, manufacturing and commercializing products utilizing its proprietary modified‐release drug delivery technology platforms. Adzenys XR-ODTTM, indicated for the treatment of ADHD in patients 6 years of age and older, is the first approved product using the Company’s XR-ODT technology platform. Neos, which is initially focusing on the treatment of ADHD, has two other branded product candidates that are XR medications in ODT or oral suspension dosage forms. In addition, Neos manufactures and markets its generic equivalent of the branded product Tussionex®1, an XR oral suspension of hydrocodone and chlorpheniramine indicated for the relief of cough and upper respiratory symptoms of a cold.
1Tussionex® is a registered trademark of the UCB Group of Companies.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements concerning the capabilities of NT-0201, the resubmission of the NDA for Cotempla XR-ODTTM, the commercialization of the Company’s products and product candidates and the development of the Company’s future product candidates. Forward-looking statements generally relate to future events or our future financial or operating performance. In some cases, you can identify forward-looking statements because they contain words such as "may," "will," "should," "expects," "plans," "anticipates," "could," "intends," "target," "projects," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these words or other similar terms or expressions that concern our expectations, strategy, plans, prospects or intentions. These forward-looking statements reflect our current views about our expectations, strategy, plans, prospects or intentions, which are based on the information currently available to us and on assumptions we have made. We caution you that the foregoing may not be the only the forward‐looking statements made in this press release. You should not rely upon forward‐looking statements as predictions of future events. These forward‐looking statements involve risks, uncertainties, assumptions and other factors that are difficult to predict and that could cause actual results to differ materially from what is expressed in or indicated by the forward‐looking statement, including the receipt of regulatory approval for Cotempla XR-ODT and NT-0201, our ability to market and sell our product candidates, our ability to raise capital when needed and other risks set forth under the caption “Risk Factors” in our most recent Quarterly Report on Form 10-Q, as updated by our other subsequently filed SEC filings.
Contacts: Richard Eisenstadt Chief Financial Officer Neos Therapeutics (972) 408-1389 [email protected] Sarah McCabe Stern Investor Relations, Inc. (212) 362-1200 [email protected]
