Amsterdam, 26 November 2019 - LSP's portfolio company Arvelle Therapeutics GmbH, an emerging biopharmaceutical company focused on bringing innovative treatments to patients suffering from CNS disorders, announced today that SK Life Science, Inc., a subsidiary of SK Biopharmaceuticals Co., Ltd., has received approval from the U.S. Food and Drug Administration (FDA) for cenobamate tablets, as a treatment for partial-onset seizures in adults (now referred to as focal-onset seizures), pending scheduling review by U.S. the Drug Enforcement Administration (DEA).
Arvelle Therapeutics has licensed exclusive rights to develop and commercialize cenobamate in Europe from SK Biopharmaceuticals. Arvelle Therapeutics intends to file a Marketing Authorization Application (MAA) for cenobamate in the EU as a treatment for focal-onset seizures in adult patients in H1 2020 based on the data generated from SK Life Science’s global clinical trial program, involving more than 1,900 patients across the Phase 2 and 3 trials.
The US approval is based on results from two randomized, double-blind, placebo-controlled studies and a large, international, multi-centre open-label safety study investigating cenobamate as an adjunctive therapy in adult patients with focal-onset seizures. In the randomized studies cenobamate demonstrated significant reductions in seizure frequency at all doses studied compared to placebo when each was added to 1 to 3 background anti-epileptic drugs. Additionally, a statistically significant number of patients showed 50% or greater reduction in seizure frequency, and some patients achieved zero seizures.
Mark Altmeyer, President and CEO of Arvelle Therapeutics said: “The FDA approval for cenobamate is a critical step forward in our efforts to bring this important potential medicine to Europe for individuals with epilepsy experiencing uncontrolled seizures. Arvelle Therapeutics has exclusive European rights to cenobamate and is working to finalize the EU Marketing Authorization Application. We believe cenobamate could potentially be a welcome new treatment option for people living with this debilitating condition.”
There are an estimated six million people in Europe with epilepsy and approximately 40% of adult patients with epilepsy have inadequate control of seizures after treatment with two anti-epileptic drug regimens.
About Arvelle Therapeutics
Arvelle Therapeutics is an emerging biopharmaceutical company focused on bringing innovative solutions to patients suffering from CNS disorders. Arvelle is responsible for the development and commercialization of cenobamate, an investigational antiepileptic drug, in the European market. Arvelle is headquartered in Switzerland. LSP led a start-up financing of $207.5 million, one of the largest initial financing commitments for a European-focused biopharmaceutical company, with investments from a global syndicate including NovaQuest Capital Management, BRV Capital Management, H.I.G. BioHealth Partners, Andera Partners, F-Prime Capital and KB Investments. More information is available at Arvelletx.com.
Arvelle Therapeutics has licensed exclusive rights to develop and commercialize cenobamate in Europe. Arvelle Therapeutics intends to file a Marketing Authorization Application (MAA) in the EU for cenobamate as a treatment for focal-onset seizures in adult patients based on the data generated from SK Biopharmaceuticals’ global clinical trial program, involving more than 1,900 patients.
About LSP
LSP (Life Sciences Partners) is an independent European investment firm, providing financing for private and public life sciences companies. LSP’s mission is to connect investors to inventors, focusing on unmet medical needs. Since the late 1980s, LSP’s management has invested in about 100 innovative enterprises, many of which have grown to become leaders in the global life sciences industry. With over €2.0 billion ($2.3bn) of investment capital raised to date and offices in Amsterdam, Munich and Boston, LSP is one of Europe’s leading life sciences investors. LSP also invests in public companies through its Euronext-listed LSP Life Sciences Fund (Bloomberg: LSP NA). More information on LSP is available at lspvc.com.
For more information please contact:
Martijn Kleijwegt, Managing Partner LSP
+31 20 664 5500
zxyrvwjrtg@yfcip.pbz