SK Biopharmaceuticals, Arvelle Partner on Anti-Epileptic Drug for Europe

February 19, 2019

In a deal worth $530 million, the companies will develop and commercialize an anti-epileptic drug candidate in Europe.

SK Biopharmaceuticals, a South Korean pharmaceutical company, and Arvelle Therapeutics, a Swiss biopharmaceutical company, announced on Feb. 14, 2019 that they have entered into an exclusive licensing agreement for Arvelle to develop and commercialize cenobamate, a small-molecule investigational antiepileptic drug, in Europe in a deal worth $530 million.

Under the agreement, SK Biopharmaceuticals will receive an upfront payment of $100 million and is eligible to receive up to $430 million upon achievement of certain regulatory and commercial milestones. The company is also eligible to receive royalties on net sales generated in Europe. SK Biopharmaceuticals will also have an option to obtain a significant equity stake in Arvelle and will also retain commercial rights for all non-European territories.

“We are very pleased to enter into this licensing agreement with Arvelle, as it provides important validation of the global potential for cenobamate as a new treatment option for adults with partial-onset seizures,” said Dr. Jeong Woo Cho, president and CEO of SK Biopharmaceuticals, in a company press release. “Arvelle’s experienced leadership team and focus on CNS disorders make them the ideal partner to advance the development and commercialization of our compound in Europe.”

Arvelle is a newly created company that received one of the largest initial financing commitments for a European-focused biopharmaceutical company from a global syndicate of investors that include NovaQuest, LSP, BRV Capital Management, Andera Partners, and H.I.G. BioHealth Partners. Mark Altmeyer leads the company as president and CEO, bringing with him more than 30 years of global biopharmaceutical experience. Formerly the president and CEO of Otsuka America Pharmaceutical, Altmeyer oversaw the growth of Abilify (aripiprazole), an anti-psychotic drug, into a multi-billion-dollar product. Most recently, Altmeyer served as president and chief commercial officer of Axovant Sciences and previously led the neuroscience business unit at Bristol-Myers Squibb Company.

“We launched Arvelle to bring truly innovative CNS [central nervous system] products to patients suffering from serious neurological conditions, and cenobamate is the perfect first pipeline product,” said Altmeyer in the company press release. “Given the data generated in clinical trials and the FDA acceptance of the NDA [new drug application], we believe cenobamate has the potential to be an important antiepileptic drug treatment option for adult patients suffering from partial-onset seizures. We appreciate the support and validation of our investors and are very enthusiastic about our potential in the European market.”

Cenobamate was discovered and developed by SK Biopharmaceuticals from inception through to the acceptance of a new drug application by FDA in February 2019. Arvelle intends to file a marketing authorization application for the drug in Europe seeking treatment for partial-onset seizures in adult patients based on data generated from a global clinical trial program run by SK Biopharmaceuticals.

Source: SK Biopharmaceuticals