Highland Therapeutics to Present Phase II Data on HLD-100, HLD-200 at AACAP Annual Meeting

TORONTO, Oct. 6, 2014 /CNW/ - Highland Therapeutics Inc. ("Highland"), today announced that Phase II data generated by the Company's principal operating subsidiary, Ironshore Pharmaceuticals & Development, Inc. ("Ironshore"), will be presented at the American Academy of Child & Adolescent Psychiatry (AACAP) Annual Meeting, which is being held October 20^th to 25^th in San Diego, CA.

Data from the HLD-200 (methylphenidate) Phase II study, The Single Dose Pharmacokinetics of HLD200:  A Modified Release Methylphenidate Formulation in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD), will be presented by Dr. Ann Childress as part of AACAP symposium #13, on Wednesday, October 22, 2014, from 1:00pm to 4:00pm.

Data from the HLD-100 (amphetamine) Phase II study, A Phase-2 Pharmacokinetic Study of a Modified Release Formulation of Dextroamphetamine Following Evening Administration to Adolescents and Children with ADHD, authored by Dr. Declan Quinn, will be presented at New Research Poster Session 4 on Friday, October 24, 2014 from 9:30am to 12:00pm.

"Growing interest in our drug development programs underscores the need for new medications that can help families better manage ADHD during the morning routine. The DELEXIS™ drug delivery platform enables stimulants, both methylphenidate and amphetamine, to be dosed at night with the objective of better managing ADHD symptoms upon waking," said David Lickrish, Highland's President and Chief Executive Officer. "Multiple surveys highlight the morning routine as the most challenging and dysfunctional time of day for ADHD patients and their families. Given Highland's unique approach to treatment, we believe our products, if approved, have the potential to change treatment paradigms in ADHD, given their potential to broaden the therapeutic window and provide control of symptoms upon awakening and throughout the day."

Dr. Bev Incledon, Ironshore's Senior Vice President, Research & Development said, "The consistent pharmacokinetics of our products have been replicated in children, adolescents and adults, suggesting that these medications, if approved, may be used across the entire age spectrum of ADHD. With currently available stimulants, which are typically dosed in the morning, there is a considerable lag between the administration of medication and its onset of action – leaving the patient effectively unmedicated during this period. Our products were designed to specifically target this unmet medical need."

Based on the strength of these Phase II data and those of prior studies, Highland initiated a Phase III study in pediatric patients in April 2014. Data from that study are expected in the fourth quarter of 2014.

About Highland Therapeutics Inc.

Highland Therapeutics Inc. is a specialty pharmaceutical company that, through its wholly owned subsidiary Ironshore Pharmaceuticals & Development, Inc., is leveraging its proprietary technology, DELEXIS™, to optimize the delivery of previously approved drug products. The Company's lead product candidates, HLD-200 and HLD-100, are novel formulations of the psychostimulants (methylphenidate and amphetamine, respectively) used to treat ADHD and are being developed to address a prevalent unmet medical need in the treatment of the disease – inadequate symptom control during the morning routine.

Highland Therapeutics Inc. is a client of MaRS Discovery District's Health Venture Services group, which provides advisory services, connections to talent, customer & capital networks, and market intelligence to high-impact, Ontario-based life sciences ventures, helping them commercialize their ideas and build globally competitive companies. 

Forward-Looking Statements
This press release contains forward-looking information, which reflects Highland's current expectations regarding future events. Forward-looking information is based on a number of assumptions and is subject to a number of risks and uncertainties, many of which are beyond Highland's control that could cause actual results and events to differ materially from those that are disclosed in or implied by such forward-looking information. These forward-looking statements are made as of the date of this press release and, except as expressly required by applicable law, Highland assumes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

SOURCE: Highland Therapeutics Inc.

Please visit the Company's website at www.highlandtherapeutics.com, or contact: Nelson F. Isabel, Chief Financial Officer, [phone]