Highland Therapeutics Announces The Issuance Of Three U.S. Patents And One Notice Of Allowance

TORONTO--(BUSINESS WIRE)--Highland Therapeutics Inc. (“Highland”), a pharmaceutical company, today announced that the U.S. Patent and Trademark Office (“USPTO”) has issued three patents and one Notice of Allowance (“NOA”) for the Company’s lead products. Two patents are for HLD-200, a next-generation formulation of methylphenidate; the other patent and the NOA are for HLD-100, a next-generation formulation of amphetamine. Both products are designed to be taken once-daily in the evening with the objective of controlling symptoms of ADHD immediately upon awakening and throughout the day. All patents are owned by Highland’s subsidiary, Ironshore Pharmaceuticals & Development, Inc. (“Ironshore”)

“Methods and Compositions for Treatment of Attention Deficit Disorder”

“With these latest issuances from the USPTO, we will have six patents protecting our late-stage compounds. We intend to further enhance our intellectual property portfolio with additional patent applications throughout 2015 and beyond,” said David Lickrish, Ironshore’s Chief Executive Officer. “Our Company understands that the current gap in coverage of ADHD symptoms during the morning routine is a major problem for many families that struggle during this critical time of day. Ironshore remains unwavering in its commitment to the development of a portfolio of products that may help to improve the lives of ADHD patients and their families. Ironshore will continue to be a reliable partner for physicians as we advance our new treatment paradigms through clinical development. The first of two planned pivotal studies for HLD-200 is expected to start in the second quarter of 2015, with top-line results anticipated within nine months.”

Patent numbers 9,034,902 “Methods of Treatment for Attention Deficit Hyperactivity Disorder”, 9,023,389 “Compositions for Treatment of Attention Deficit Hyperactivity Disorder” and 9,028,868 “Methods and Compositions for Treatment of Attention Deficit Disorder” will expire in 2032. The NOA is for patent application # 14/255,529. When issued, the patent arising from this NOA will also expire 2032.

Ironshore intends to list the patents in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book, upon U.S. regulatory approval of HLD-200 and HLD-100.

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. Intended for nighttime dosing, DELEXIS® is designed to provide a consistent delay in the initial release of the active drug, followed by a period of extended release; with the objective of providing control of ADHD symptoms immediately upon wakening and throughout the day.

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.

For further information, please visit the Company’s website at www.highlandtherapeutics.com.

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.