Highland Therapeutics Announces Results of Extensive Physician Survey

TORONTO--()--Highland Therapeutics today announced that the results from a physician survey – commissioned by its wholly owned subsidiary, Ironshore Pharmaceuticals & Development, Inc. (Ironshore) – highlight the need for new treatment options for the management of Attention Deficit Hyperactivity Disorder (ADHD). The survey of 433 physicians makes this research one of the most comprehensive studies to document physician attitudes and perceptions of the current complement of treatment options for patients with ADHD. The results echo the findings from an earlier survey commissioned by Highland, and together, the data indicate that the DELEXIS® platform represents a potential paradigm shift in the management of ADHD given its apparent ability to dose a stimulant at night to broaden the therapeutic window, targeting an effect immediately upon awakening and into the evening homework period.

Details from the study indicated that an estimated 80% of physicians would inquire about symptoms during the morning routine upon FDA approval of HLD-200 (Ironshore’s next-generation methylphenidate formulation); while over 70% indicated they were likely to prescribe the medication.

“These results underscore the need for us to encourage patients, parents and physicians to renew their conversation about the early morning routine given the new treatment options under development,” said Tom Curatolo, Executive Vice President, Commercial Operations & Strategy of Ironshore Pharmaceuticals (America), Inc., or IPA. “As expected, this study confirms that when this conversation takes place, doctors are likely to prescribe a stimulant that provides more comprehensive control over the symptoms of ADHD.”

“The survey results indicate that physicians intend to integrate HLD-200 quickly into their ADHD armamentarium, given the pent-up demand in the market and the product’s unique value proposition,” said Dr. Bev Incledon, Executive Vice President, Research & Development. “It is also noteworthy that the study revealed that the potential for improved functioning during the early morning routine took priority over stimulant class, which implies that our lead compound (HLD-200) is likely to pull market share from both amphetamine- and methylphenidate-based treatment options in equal measure.”

Prior research has shown that one-third of pediatric and adolescent patients with ADHD demonstrate a preferential response to methylphenidate, one-third to amphetamine and the remaining one-third respond equally well to either drug class. This important fact highlights the need for a portfolio approach to disease management. Ironshore is committed to advancing its next-generation amphetamine drug (HLD-100) into pivotal trials in 2016.

Commenting on the survey results, Dr. Randy Sallee, Chief Medical Officer, stated, “Psychiatrists, high-volume prescribers and pediatricians are generally aware of the difficulties experienced by patients and families during the early morning routine. Most physicians, however, underestimate the severity and pervasiveness of the problem across the patient population. That apparent gap in understanding widens appreciably as we look across the field from very high-volume prescribers to lower-volume prescribers in a primary care setting. This underscores the need for future research in this understudied area.”

Specific details regarding the survey will be published in a prominent peer reviewed journal and presented in poster format at future medical conferences.

About HLD-200
HLD-200 is a novel, delayed-release, extended-release formulation of methylphenidate based on Ironshore Pharmaceuticals & Development, Inc.’s proprietary DELEXIS® technology. HLD-200 is designed to be taken once-daily in the evening with the objective of controlling symptoms and improving functioning in ADHD patients immediately upon awakening and throughout the day. An exploratory Phase III study was successfully completed in pediatric ADHD patients in 2014. Two pivotal Phase III studies are ongoing, with top-line data anticipated in the first quarter of 2016.

About Highland Therapeutics Inc.
Highland Therapeutics Inc. is a 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.

Contacts

Highland Therapeutics
Nelson F. Isabel, 647-260-7875
Chief Financial Officer

Contacts

Highland Therapeutics
Nelson F. Isabel, 647-260-7875
Chief Financial Officer