PHILADELPHIA, PA, May 11, 2022 — 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 Japan Patent Office has granted Patent No. 7054709 titled, “Abuse Deterrent Formulations of Amphetamine,” covering ADAIR1, the Company’s proprietary abuse-deterrent formulation of immediate-release dextroamphetamine.
David Baker, President & Chief Executive Officer of Vallon commented, “The Japanese market is one of the fastest growing markets for prescription ADHD medications. Historically, there has been concern over the abuse potential of psychostimulants in Japan, however, this has begun to change in recent years with the introduction of several new products. As we continue to evaluate the best path forward for our novel abuse-deterrent formulation of dextroamphetamine, ADAIR, we are pleased to expand its global intellectual property portfolio. We are working to evaluate and unlock its potential and importantly, move toward potentially bringing a safe and effective option to ADHD patients in need.”
The new Japanese patent covers composition of matter and methods of manufacturing 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 and one patent in Europe with a base patent term extending until 2038.
ADAIR (Abuse Deterrent Amphetamine Immediate Release) is an investigational new drug; a novel, patented formulation of dextroamphetamine designed to deter attempts to crush and snort it or take it by other non-oral routes that can produce a greater “high.” Dextroamphetamine has been used clinically for more than 50 years. It is the same active ingredient used in FDA-approved products, such as Adderall®, Dexedrine®, and Vyvanse®. ADAIR is not approved by the U.S. Food and Drug Administration (“FDA”).
About Vallon Pharmaceuticals, Inc.
Vallon Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company, headquartered in Philadelphia, PA. The Company is focused on the development of new medications to help patients with CNS disorders. The Company’s lead investigational product candidate, ADAIR, is a novel abuse-deterrent formulation of amphetamine immediate release being developed for the treatment of ADHD and narcolepsy.
The Company recently announced it is evaluating strategic alternatives with the goal of maximizing shareholder value, which could include, without limitation, exploring the potential for a possible merger, business combination, investment into the Company, or a purchase, license or other acquisition of assets. This process may not result in any transaction and the Company does not intend to disclose additional details unless and until it has entered into a specific transaction.
References and links to websites have been provided for convenience, and the information contained on any such website is not a part of, or incorporated by reference into, this press release. Vallon is not responsible for the contents of third-party websites.
Forward Looking Statements
This press release contains “forward-looking statements” that are based on Vallon’s current expectations and subject to inherent uncertainties, risks and assumptions that are difficult to predict, including, without limitation, Vallon’s ability to execute its business plan, continue its growth and fund its ongoing business activities as planned, Vallon’s ability to develop and commercialize its product candidates, expectations related to results of clinical trials and studies, Vallon’s expectations with respect to the important advantages it believes its abuse-deterrent formulation of drugs have over similar drugs in the market and the growing need for abuse-deterrent formulations of drugs, Vallon’s ability to utilize the 505(b)(2) regulatory pathway, Vallon’s ability to obtain FDA approval of ADAIR and its other product candidates, Vallon’s assessment of the best path forward for ADAIR and the completion of the development or commercialization of ADAIR, Vallon’s ability to identify, evaluate and complete any strategic alternative that yields value for its shareholders, and Vallon’s expectations with respect to its cash runway. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in Vallon’s Quarterly and Annual Reports filed with the U.S. Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law.
JTC Team, LLC
1 ADAIR is not approved by the FDA