Benzinga | Jul 13, 2021 08:11AM EDT

Vallon Pharmaceuticals Announces Issuance Of New European Patent Covering Method Of Use, Composition OF Matter For ADAIR

Vallon Pharmaceuticals Inc. (NASDAQ:VLON), ("Vallon" or the "Company"), a clinical-stage biopharmaceutical company primarily focused on the development of novel drugs that are designed to deter abuse in the treatment of central nervous system (CNS) disorders, today announced that the European Patent Office has issued patent number EP3576719B1 covering ADAIR1, the Company's proprietary abuse-deterrent formulation of immediate-release dextroamphetamine.

ADAIR is being developed for Europe and the UK through a license and collaboration agreement with MEDICE Arzneimittel P?tter GmbH, a leader in the European ADHD market. Under the terms of the agreement, Vallon will receive development and sales milestone payments and double-digit sales-based royalty payments. The issuance of this Composition of Matter and Method of Use patent provides additional protection as MEDICE works towards the potential commercialization of ADAIR in the European Union and United Kingdom. In the US, the Company continues to develop ADAIR, leveraging the 505(b)(2) regulatory pathway. The Company is currently conducting a pivotal intranasal abuse study, the SEAL Study, in recreational drug abusers.

David Baker, President & Chief Executive Officer of Vallon commented, "There is a clear and growing unmet need for products that can treat ADHD effectively while attending to the significant problem of stimulant misuse. We continue to be encouraged by the potential of our novel platform technology, which we believe can also be applied to other prescription drugs that have abuse potential. We are pleased to successfully expand our intellectual property portfolio with the issuance of this new European patent."

The new European patent covers composition of matter and method of use for ADAIR, with a base patent term extending until 2038. The design and development of an abuse-deterrent formulation involves the balance of limiting the potential for manipulation and abuse while maintaining acceptable dissolution rates and bioavailability. ADAIR was previously granted two patents in the United States with a base patent term extending until 2037, excluding patent term extensions.