GRI Bio has entered an asset purchase agreement with Aardvark Therapeutics for the acquisition of specific assets and intellectual property related to ADAIR, an abuse-deterrent formulation of immediate-release dextroamphetamine for ADHD treatment. Aardvark plans to use the ADAIR technology for developing follow-on pipeline programs. GRI Bio will receive an upfront payment and potential milestone payments up to around $80 million. GRI Bio’s CEO sees this as an opportunity to optimize their assets while focusing on their pipeline for inflammatory and fibrotic diseases.
GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (“NKT”) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced that the Company has entered into an asset purchase agreement pursuant to which Aardvark Therapeutics, Inc. (“Aardvark”) will acquire certain assets and intellectual property of the Company that pertain to ADAIR (Abuse Deterrent Amphetamine Immediate Release). Aardvark intends to utilize the ADAIR formation technology for the development of certain follow-on pipeline programs.
ADAIR, a legacy asset from the merger with Vallon Pharmaceuticals, Inc. (“Vallon”), is a proprietary abuse-deterrent formulation of immediate release dextroamphetamine for the treatment of attention deficit hyperactivity disorder (“ADHD”) designed to deter attempts to crush and snort it or take it by other non-oral routes that can produce a greater “high.”
Under the terms of the agreement, Aardvark will assume responsibility for and endeavor to develop and commercialize the purchased assets. Exclusive license rights to develop and commercialize ADAIR in Europe and the UK were previously licensed to Medice Arzneimittel Pütter GmbH, a leader in the European ADHD market. GRI Bio will receive a modest up-front payment and the potential to earn milestone payments for achievements in development and commercialization from Aardvark up to approximately $80 million.
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“This agreement represents a great opportunity for GRI Bio as it allows us to optimize our non-strategic asset that we acquired through our merger with Vallon, while allowing us to maintain our focus on advancing our pipeline of novel assets in development for inflammatory and fibrotic diseases. We believe in the potential of ADAIR and are pleased to have it continue on in its development at Aardvark,” commented Marc Hertz, PhD, Chief Executive Officer of GRI Bio.
“There continues to be an unmet need for effective products that address the significant and growing problem of stimulant misuse and abuse. ADAIR has demonstrated abuse deterrent properties, but did not surmount the established threshold in its most recent clinical trial to support pursuing an FDA approval. However, we believe there is a real opportunity to utilize Aardvark’s proprietary ARD-101 technology with its established clinical safety profile to provide a new formulation to substantially boost the deterrent effect of ADAIR to ultimately gain regulatory approval,” added Tien Lee, M.D., Chief Executive Officer of Aardvark.
As the current lead programs utilizing ARD-101 as an orally administered therapeutic agent for Prader-Willi Syndrome will be continuing at Aardvark unabated, Aardvark is considering establishing a separate entity to continue development of ADAIR with ARD-101 to address the urgent need for effective products that will deter stimulant abuse.
Source: BioSpace