Highland Therapeutics Appoints Dr. Floyd R. Sallee Chief Medical Officer

TORONTO, Sept. 24, 2014 /CNW/ - Highland Therapeutics Inc. ("Highland"), today announced the appointment of Dr. Floyd R. Sallee as Chief Medical Officer of Ironshore Pharmaceuticals & Development, Inc. ("Ironshore"), Highland's wholly owned principal operating subsidiary.

As an expert in pediatric psychopharmacology, Dr. Sallee has been an important adviser and consultant to Ironshore on the development of the Company's investigational drug products, HLD-100 (amphetamine) and HLD-200 (methylphenidate), since 2011. In addition to his expertise is pharmacology, Dr. Sallee brings a wealth of experience in the field of Pediatric Psychiatry and specifically in Attention Deficit Hyperactivity Disorder (ADHD), where he has published more than 100 papers in scientific journals including the Journal of Child and Adolescent Psychopharmacology and the Journal of Attention Disorders.

 "Over the past several years we have benefited greatly from Dr. Sallee's guidance and expertise. I am delighted to have him renew and deepen that commitment in this critical position as Chief Medical Officer," said David Lickrish, Highland's President & Chief Executive Officer. "In his capacity as CMO, Dr. Sallee will oversee the clinical development of Ironshore's pipeline. His expertise in ADHD, in conjunction with his extensive experience in clinical trials, will be instrumental as we complete the Phase III trial of HLD-200. Results from this study are expected prior to year end."

Dr. Sallee is Board Certified in Psychiatry, Child Psychiatry and Clinical Pharmacology. Prior to joining Ironshore, Dr. Sallee was a Professor of Psychiatry and Neuroscience at the University of Cincinnati School of Medicine. He has also held the positions of Vice Chairman and Division Chief of Child Psychiatry at Cincinnati Children's Hospital Medical Center. As a leader in pediatric clinical pharmacology, Dr. Sallee founded the Pediatric Pharmacology Research Unit (PPRU) at Cincinnati Children's Hospital and is credited with supporting pediatric labeling for over 50 marketed drugs including Adderall XR, Concerta and Vyvanse.  

Commenting on his appointment, Dr. Sallee said, "I am delighted to be joining Ironshore at such an exciting time in its development. The company's two lead product candidates, HLD-100 and HLD-200, have the potential, if approved, to have a profound impact on paradigms for the treatment of ADHD. While there are many alternative treatment options for physicians to choose from, there are no stimulants that specifically target symptom control during the morning routine. Ironshore's unique approach to dosing is designed to broaden the therapeutic window of stimulants and, if approved, may mark the first time that physicians would have an oral treatment option for relief of symptoms associated with ADHD during the morning routine and throughout the day."

Dr. Sallee's research has been continuously funded by the National Institutes of Health since 1990. Among many distinguished awards, Dr. Sallee has won the prestigious Sandoz Award in Psychiatry and the National Institutes of Health (NIH) Physician Scientist Award. 

Dr. Sallee received his PhD in Pharmacology from the University of Pittsburgh and his M.D. from the SIU School of Medicine.

Mr. Lickrish added, "The addition of Dr. Sallee is the first of a number of planned senior hires being contemplated. The clinical data generated to date suggest that HLD-200 could, if approved, represent a first-line therapy in ADHD, and as such, our commercial organization must continue to expand to ensure we have all the strategies, tactics and resources in place to pursue regulatory approval and plan for an optimal commercial launch."

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 – the lack of 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.

Nelson F. Isabel, Chief Financial Officer, [phone]