DALLAS and FORT WORTH, Texas, July 28, 2016 (GLOBE NEWSWIRE) -- 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), today announced the successful completion of a bioequivalence bridging study for
its late stage product candidate, Cotempla XR-ODT (methylphenidate extended-release orally disintegrating tablet).
Cotempla XR-ODT met all of the primary and secondary endpoints, including partial AUCs, for establishing
bioequivalence under fasting conditions. A Complete Response Letter for Cotempla XR-ODT was issued by the U.S. Food and Drug
Administration (FDA) on November 6, 2015, requiring the Company to conduct a bridging study to demonstrate bioequivalence between
the clinical trial material and the to-be-marketed commercial scale drug product, including an assessment of food effect, and to
provide validation and three months of stability data.
“We are delighted with the results of our bioequivalence study and look forward to re-submitting our New Drug
Application to the FDA for Cotempla XR-ODT by the end of this year and the anticipated marketing approval in time for the 2017
back-to-school season,” said Vipin K. Garg, PhD, President and CEO of Neos Therapeutics.
About ADHD
According to the Centers for Disease Control and Prevention, ADHD is one of the most common childhood disorders and can continue
through adolescence and adulthood1. In fact, ADHD is estimated to affect 5 percent of children and 2.5 percent of adults
in the U.S.2 Symptoms include inattentiveness, hyperactivity and impulsiveness2. These patterns of behavior
are seen in many settings (school, home, work) and can impact performance and relationships.
Stimulant medications such as amphetamine and methylphenidate are the standard of care for treating ADHD, and
extended-release (XR) formulations of these medications allow for once-daily dosing3. Most of the existing treatment
formulations are tablets or capsules, which need to be swallowed intact or in some cases sprinkled on certain foods or fluids and
ingested immediately. Orally disintegrating tablets differ from traditional tablets and capsules in that they are designed to
disintegrate in the mouth, rather than being swallowed whole.
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-ODT™ is the first and only commercially available
amphetamine extended-release orally disintegrating tablet for the treatment of ADHD. Neos has two other branded product candidates
in development, an XR-ODT of methylphenidate and a liquid suspension of amphetamine for the treatment of ADHD. In addition, Neos
manufactures and markets its generic equivalent of the branded product Tussionex®4, an XR liquid suspension of
hydrocodone and chlorpheniramine indicated for the relief of cough and upper respiratory symptoms of a cold.
Special Note Regarding 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 clinical development, regulatory approval and the therapeutic
potential of Cotempla XR-ODT and other products and 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 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. Although we
believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking
statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or
achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be
affected by a variety of risks and factors that are beyond our control including, without limitation, our ability to successfully
address the deficiencies identified by the FDA or which may be identified by the FDA which preclude approval of the NDA for our
Cotempla XR-ODT product candidate, the receipt of regulatory approval for our product candidates and other risks set forth under
the caption “Risk Factors” in our most recently filed Annual Report on Form 10-K as updated by our subsequently filed
other SEC filings, including our Quarterly Report(s) on Form 10-Q. We assume no obligation to update any forward-looking statements
contained in this document as a result of new information, future events or otherwise.
1 Centers for Disease Control. Attention-Deficit/Hyperactivity Disorder (ADHD). http://www.cdc.gov/ncbddd/adhd/facts.html Accessed July 27, 2016.
2 American Psychiatric Association. (2013) Diagnostic and Statistical Manual of Mental Disorders, Fifth
Edition, Arlington, VA.
3 Chew RH, Hales RE, Yudofsky SC: What Your Patients Need to Know About Psychiatric Medications, Second
Edition. Washington, DC, American Psychiatric Publishing, 2009
4 Tussionex® is a registered trademark of the UCB Group of Companies
CONTACTS: Richard I. Eisenstadt Chief Financial Officer Neos Therapeutics (972) 408-1389 reisenstadt@neostx.com David Carey Investor Relations Lazar Partners (212) 867-1768 dcarey@lazarpartners.com