Under the terms of the agreement, Aardvark Therapeutics will have the global development and commercialisation rights to ADAIR and all intellectual property outside of Europe and licensor rights for the European Union
Aardvark Therapeutics to acquire the ADAIR formation technology from GRI Bio. (Credit: Constantin Wenning on Unsplash)
US-based biotechnology company GRI Bio has agreed to sell certain assets and intellectual property of the ADAIR (Abuse Deterrent Amphetamine Immediate Release) formation technology to Aardvark Therapeutics.
Aardvark Therapeutics will make a modest upfront payment to GRI Bio as consideration along with potential payments of up to $80m for achievements in development and commercialisation.
ADAIR is a legacy asset that was added by GRI Bio earlier this year through the merger with Vallon Pharmaceuticals. The asset is a proprietary abuse-deterrent formulation of immediate release dextroamphetamine intended for treating attention deficit hyperactivity disorder (ADHD).
According to the terms of the agreement, the US-based Aardvark Therapeutics will acquire global development and commercialisation rights to ADAIR and all intellectual property outside of Europe and licensor rights for the European Union.
Previously, the exclusive license to develop and commercialise ADAIR in Europe and the UK was granted to Medice Arzneimittel Pütter, which is engaged in the European ADHD market.
GRI Bio CEO Marc Hertz said: “This agreement represents a great opportunity for GRI Bio as it allows us to optimise 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.”
Aardvark Therapeutics plans to use the ADAIR formulation technology for certain follow-on pipeline programmes in development, including ARD-101.
The company will continue its existing lead programmes using ARD-101 as an oral therapeutic agent for Prader-Willi Syndrome.
Furthermore, Aardvark Therapeutics is exploring the idea of creating a separate entity to continue the development of ADAIR with ARD-101 to address the urgent requirement for effective products that will discourage stimulant abuse.
Aardvark Therapeutics CEO Tien Lee said: “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 utilise 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.”