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news.Highland Therapeutics, a pharmaceutical company, announced that the US Patent and Trademark Office (USPTO) has issued a Notice of Allowance for a patent application owned by the company's wholly owned subsidiary, Ironshore Pharmaceuticals & Development.
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The Notice of Allowance is for U.S. Patent Application No. 14/230,067, "Methods for Treatment of Attention Deficit Hyperactivity Disorder", which relates to HLD-200, including its unique pharmacokinetic profile. Highland recently reported positive top-line Phase III data for HLD-200. A pivotal trial is anticipated to begin in the first half of 2015.
"A strong intellectual property estate has always been an overarching objective of the Company, and we are pleased by the Notice of Allowance for our lead product, the first of many we anticipate being issued," said David Lickrish, Highland’s President and Chief Executive Officer.
"As seen in the data from our Phase III study, our unique approach to the treatment of ADHD has the potential to expand the therapeutic window of currently available stimulants. We believe our development candidates, if approved, may represent the next generation of these important medications, with the potential to control symptoms of ADHD upon awakening and throughout the day."
The Notice of Allowance signals the end of the substantive examination of the patent application by the USPTO. After the administrative processing period is complete, a U.S. patent will be issued, likely before the end of the year.
The US patent scheduled to issue from this application will expire in 2032. After issuance, Ironshore plans to list the patent in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book, upon US regulatory approval of HLD-200.
Highland believes there is a growing appreciation about the critical importance of complex pharmacokinetic profiles on clinical outcomes, as evidenced by the FDA’s Draft Guidance on Methylphenidate Hydrochloride, issued November 6, 2014.