Splash Beverage Group Acquires Exclusive Global Rights to CannEpil for Drug-Resistant Epilepsy
Key Insights
Splash Beverage Group (search) has secured exclusive global licensing rights to CannEpil, a pharmaceutical-grade cannabinoid therapy for drug-resistant epilepsy (search), from Argent BioPharma Limited (search).
CannEpil has already achieved patient access in Ireland, the UK, Germany, and Australia, with reimbursement-supported pathways and real-world clinical experience in Europe.
The therapy has engaged with the U.S. FDA through the pre-IND process and received an IND number, laying groundwork for future U.S. clinical development.
Splash Beverage Group (search), Inc. (NYSE American: SBEV) announced today that it has entered into an exclusive global licensing agreement with Argent BioPharma Limited (search) (ASX/LSE: RGT) for CannEpil, a proprietary, pharmaceutical-grade cannabinoid-based investigational therapeutic developed for the treatment of drug-resistant epilepsy (search) (DRE). The agreement grants Splash exclusive worldwide rights to develop, commercialize, market, distribute, sublicense, and sell CannEpil for drug-resistant epilepsy, refractory epilepsy, seizure disorders, and related neurological conditions.
Drug-resistant epilepsy (search) 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.
Established International Presence and Regulatory Progress
CannEpil is not an early-stage laboratory asset. The therapy has already been prescribed through regulated patient-access programs and has been made available in multiple international markets, including Ireland, the United Kingdom, Germany, and Australia. Manufactured under European Union Good Manufacturing Practice (EU-GMP) standards, CannEpil has generated meaningful real-world patient experience and established reimbursement-supported access in Europe.
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.
U.S. Development Pathway
The CannEpil program has initiated formal engagement with the U.S. Food and Drug Administration through the pre-IND (Investigational New Drug) process and has been assigned an IND number, providing a foundation for future U.S. clinical development. Splash intends to deploy proceeds from a newly secured $1 million strategic investment commitment from C/M Capital Partners 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.
Strategic Rationale
"What attracted us to CannEpil is that this is not an early-stage laboratory asset," Splash management stated. "CannEpil has already been prescribed through regulated patient-access programs, has established reimbursement-supported access in Europe, has generated meaningful real-world patient experience and has already engaged with the FDA regarding its U.S. development pathway."
The company views the acquisition as an important step in building a differentiated cannabinoid therapeutics platform, leveraging existing international commercialization while pursuing U.S. regulatory advancement and strategic pharmaceutical partnerships.
Transaction Details
Under the terms of the agreement, the license encompasses all global territories and includes rights to future product improvements, reformulations, and next-generation product developments within the licensed field. 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.
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 $5.5 million of newly issued Splash preferred equity. Argent BioPharma is incentivized to continue participating in the long-term success of the program through a royalty equal to 15% of net revenue generated from worldwide sales of CannEpil.