Splash Beverage Group Secures Global Rights to CannEpil® for Epilepsy Treatment

In a significant move for the healthcare sector, Splash Beverage Group, Inc. (NYSE American: SBEV) has announced the acquisition of exclusive global licensing rights to CannEpil®, an innovative cannabinoid-based therapy aimed at treating drug-resistant epilepsy (DRE). The deal, finalized with Argent BioPharma Limited, positions Splash at the forefront of a burgeoning specialty neurology market.

CannEpil® is designed specifically for individuals grappling with epilepsy that does not respond to conventional medications — a condition affecting roughly 30% of patients suffering from epilepsy worldwide. For many of these individuals, traditional therapies fail to provide adequate seizure control, underscoring the critical need for effective alternatives.

The therapeutic has already gained authorization in several European countries, including Ireland, the United Kingdom, Germany, and Australia, where it is manufactured according to stringent EU Good Manufacturing Practice (EU-GMP) standards. With an established distribution framework and mechanisms for reimbursement already in place, Splash sees CannEpil® as a game-changer in the treatment of epilepsy.

Brady Cobb, the Interim CEO of Splash Beverage Group, noted, “Acquiring exclusive global rights to CannEpil represents a transformational milestone for Splash. It not only gives us a foothold in an attractive specialty neurology market but also comes with valuable real-world patient data and regulatory engagement that can accelerate our plans in the U.S.”

CannEpil® has been integrated into patient-access programs in Ireland, where it is facilitated through the country’s Medicinal Cannabis Access Program (MCAP). In the UK, it has received authorization for importation and can be prescribed through the Named Patient Request framework, indicating its integration into specialized treatment pathways for severe epilepsy cases. This established presence in Europe means that Splash can benefit from existing knowledge and practices as it prepares for U.S. clinical developments.

The company is already taking steps to engage with the U.S. Food and Drug Administration (FDA) to pave the way for CannEpil®’s clinical trials in the United States. Following initial engagement via the pre-Investigational New Drug (IND) process, Splash has secured an IND number, marking a promising step forward.

In addition to this strategic licensing agreement, Splash Beverage Group has also attracted a $1 million investment from C/M Capital Partners. This fund will bolster efforts related to regulatory advancement, clinical development, marketing strategies, and partnership initiatives designed to expedite CannEpil®’s U.S. market entry.

The details of the licensing agreement reveal that Splash has acquired worldwide rights to develop, commercialize, market, and distribute CannEpil® for DRE and related neurological conditions. This grants them control over future product enhancements as well, ensuring that they remain at the top of any forthcoming innovations.

As part of the agreement, Splash has also structured financial arrangements that include a capital infusion of $1 million and the issuance of $5.5 million in preferred equity to Argent, helping align the stakeholders' interests as they progress in the commercialization of CannEpil®.

Argent BioPharma is set to benefit as well, with a royalty of 15% on net revenue from the global sales of CannEpil®. This partnership structure incentivizes ongoing collaboration, enhancing both companies' prospects in tackling the global challenge of drug-resistant epilepsy.

As Splash Beverage Group advances toward its goal of becoming a leader in the cannabinoid health sector, this acquisition of CannEpil® not only affirms its commitment to improving patient outcomes but also showcases the potential for generating significant shareholder value in the competitive world of biopharma. With millions of epilepsy patients in need, CannEpil® stands to be a vital contributor to the future of neurological care.