FORT LAUDERDALE, Fla. — Splash Beverage Group Inc. has entered into an exclusive global licensing agreement with Argent BioPharma Limited for CannEpil®, a proprietary, cannabinoid-based investigational therapeutic for the treatment of drug-resistant epilepsy (DRE) in multiple European countries.
CannEpil is a pharmaceutical-grade cannabinoid-based treatment that has been made available in multiple international markets, including Ireland, the United Kingdom, Germany and Australia. The therapy is manufactured under European Union Good Manufacturing Practice (EU-GMP) standards.
Drug-resistant epilepsy affects approximately 30% of epilepsy patients worldwide and remains one of the most significant unmet needs in neurology, with millions of patients continuing to experience uncontrolled seizures despite currently available therapies.
In Ireland, the therapy became eligible under the country’s Medicinal Cannabis Access Program (MCAP) and is supported through reimbursement mechanisms administered by Ireland’s Health Service Executive (HSE). In the United Kingdom, CannEpil has been authorized for importation and prescription through the Named Patient Request framework and has been utilized through specialist treatment pathways serving patients with severe treatment-resistant epilepsy.
The program has also initiated formal engagement with the U.S. Food and Drug Administration through the pre-Investigational New Drug (IND) process and has been assigned an IND number, providing a foundation for future U.S. clinical development.
As part of the transaction, Splash has secured a $1 million strategic investment commitment from C/M Capital Partners to support regulatory advancement, clinical development planning, commercialization initiatives and strategic partnership activities designed to accelerate the development of CannEpil in the United States and other key markets.
Splash intends to deploy proceeds from the strategic investment toward advancing FDA-related activities, expanding the existing clinical and real-world evidence package, engaging leading U.S. epilepsy investigators and identifying a strategic pharmaceutical development partner capable of supporting future U.S.-based clinical trials.
Transaction details
Under the terms of the agreement, Splash has acquired exclusive worldwide rights to develop, commercialize, market, distribute, sublicense, and sell CannEpil® for the treatment of drug-resistant epilepsy, refractory epilepsy, seizure disorders, and related neurological conditions.
The license encompasses all global territories and includes rights to future product improvements, reformulations and next-generation product developments within the licensed field.
In addition to its affiliate’s $1 million capital infusion described above and as consideration for the transaction, Mercer Street Global Opportunity Fund agreed to forgive approximately $5 million of Argent BioPharma indebtedness and Splash agreed to issue to $5.5 million of newly issued Splash preferred equity as part of the consideration for the license, aligning stakeholders behind the future development and commercialization of the CannEpil platform.
Argent BioPharma is incentivized to continue to participate in the long-term success of the program through a royalty equal to 15% of net revenue generated from worldwide sales of CannEpil.
The agreement grants Splash exclusive worldwide commercialization rights for an initial twenty-year term and includes rights to sublicense the technology to strategic pharmaceutical partners globally.
