Cenobamate (YKP3089) was discovered by SK Biopharmaceuticals and SK life science and is a new U.S. Food and Drug Administration (FDA) approved anti-epileptic drug (AED) for the treatment of partial-onset (focal) seizures in adults. Cenobamate will be available in the U.S. pending review by the U.S. Drug Enforcement Administration (DEA) in 2020. It is not yet approved by any other regulatory authorities.
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 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.
Cenobamate is believed to reduce repetitive neuronal firing by inhibiting voltage-gated sodium currents and as a positive allosteric modulator of the GABAA ion channel.
Global trials for adults with partial-onset seizures are ongoing to evaluate cenobamate’s long-term safety and additional clinical trials are investigating cenobamate in other seizure types.
Cenobamate’s mechanism of action is not fully understood, but it is believed to work through two separate mechanisms: enhancing inhibitory currents through positive modulation of GABA-A receptors and decreasing excitatory currents by inhibiting the persistent sodium current.
MARK ALTMEYER
Founder,
Chief Executive Officer
ILISE LOMBARDO, MD
Founder,
Chief Medical Officer
GREGORY WEINHOFF, MD
Founder,
Chief Financial Officer & Business Officer
PETRA MOLAN
Senior Vice President Commercial
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ENRICO DOLFINI
Vice President Legal Counsel
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Zug, Switzerland, December 4, 2019 – Arvelle Therapeutics GmbH (“Arvelle”), an emerging biopharmaceutical company focused on bringing innovative treatments to patients suffering from CNS disorders, today announces that Dr Otto Schwarz will join the Board of Arvelle Therapeutics as an Independent Director and serve as Chairman of the Board, with immediate effect. Dr Otto Schwarz
Approval based on pivotal trials that assessed the efficacy and safety of cenobamate Arvelle Therapeutics has exclusive rights to develop and commercialize cenobamate in Europe Arvelle Therapeutics plans to submit a Marketing Authorization Application in Europe in H1 2020 Zug, Switzerland, November 25, 2019 – Arvelle Therapeutics GmbH, an emerging biopharmaceutical company focused on bringing
Zug, Switzerland, November 20, 2019 – Arvelle Therapeutics GmbH, an emerging biopharmaceutical company focused on bringing innovative treatments to patients with CNS disorders, is pleased to announce that Arvelle has won the 2019 Lifestars “Series A Finance Raise of the Year” Award. Mark Altmeyer, President and CEO of Arvelle Therapeutics, said: “We are delighted to
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Founder, Chief Executive Officer
Mr. Altmeyer is a Founder, Board Member and the Chief Executive Officer of Arvelle. He has 30 years of experience leading successful drug commercialization efforts as a pharmaceutical executive, with a focus on therapies for central nervous system (CNS) disorders. He was previously President and Chief Commercial Officer at Axovant.
Prior to that Mark was Chief Executive Officer and President of Otsuka America Pharmaceutical, Inc., where he led a team of 1,700 employees and helped grow the company’s revenue from $2.6 billion to over $5 billion. He led the launch of Abilify®, the top-selling CNS drug in history and the number-one selling drug in the United States in 2013. Earlier in his career, Mr. Altmeyer held a number of executive leadership roles at Bristol-Myers Squibb, including Senior Vice President, Global Commercialization, and Senior Vice President, Neuroscience Business Unit. Mr. Altmeyer received an M.B.A. from Harvard Business School and a B.A. in economics from Middlebury College.
Founder, Chief Medical Officer
llise Lombardo, MD is a Founder and the Chief Medical Officer of Arvelle. Prior to that she was Chief Medical Officer at Axovant. She has 15 years of experience leading clinical development and medical affairs programs across multiple therapeutic areas including neurological and psychiatric disorders. Dr. Lombardo has successfully managed clinical development and strategy, regulatory authority approval, and post-marketing activities.
Previously, she was Vice President, Clinical Development and Medical Affairs, at FORUM Pharmaceuticals. Dr. Lombardo also previously led a multitherapeutic Medical Affairs group and development teams at Pfizer. She is a trained psychiatrist and has worked in academic research and clinical practice. Prior to entering the pharmaceutical industry, she was an Assistant Professor of Clinical Research at Columbia University College of Physicians and Surgeons and the New York State Psychiatric Institute. Dr. Lombardo received an M.D. from Yale University, an M.Phil. from the University of Cambridge, and an A.B. from Brown University.
She completed a research fellowship in molecular biology at Yale University and the University of Cambridge and completed her internship and residency in psychiatry as well as a four-year post-doctoral fellowship in molecular neuroimaging at Columbia University College of Physicians and Surgeons.
Founder, Chief Financial Officer & Business Officer
Gregory Weinhoff, MD is a Founder, Board Member and Chief Financial Officer and Chief Business Officer. He previously served as Chief Financial Officer of Axovant Sciences. He has more than 20 years of experience in healthcare finance and operations as a venture capital investor and operating executive. Previously, Dr. Weinhoff was a partner at CHL Medical Partners, where he focused on investments in start-up and early-stage companies across biotechnology, diagnostics, medical devices and healthcare services.
He was the founding Chief Executive Officer of Amicus Therapeutics and subsequently served on the company’s board of directors. He also held positions in the healthcare groups at J.H. Whitney & Co. and Morgan Stanley & Co. Dr. Weinhoff received an M.D. from Harvard Medical School, an M.B.A. from Harvard Business School (Baker Scholar), and an A.B. in economics from Harvard College.
Vice President Legal Counsel
Enrico brings more than 20 years of international private practice and in-house legal experience in both large and mid-size pharmaceutical companies. Before joining Arvelle, he served as Vice President of International Legal Affairs for Sarepta International Holdings where he partnered cross-functionally to accelerate the company’s expansion in both traditional and emerging markets. Prior to that, he served as Head of Legal Europe and LATAM for Ultragenyx and has also held roles of increasing responsibility at Shire, including Head of EAMEA and international lead lawyer for some of their rare disease products. Earlier in his career, he held a number of leadership roles at Roche, Novartis and Klegal where he advised on corporate transactions and represented clients in court litigations and arbitrations.
Senior Vice President Commercial
Petra is a seasoned healthcare professional with over 20 years of pharmaceutical commercialization experience. Petra joins Arvelle from Takeda Pharmaceuticals where she was SVP, Global Head of Rare Hematology Franchise, Patient Value & Product Strategy. Prior to that she held the position of GVP, Global Head of Internal Medicine Franchise, Global Strategic Marketing at Shire. While in these roles, Petra led the global launch of various brands, delivering strategic direction and guidance and preparing the organizations to launch products immediately once approved. Prior to her global strategic roles at Takeda and Shire, Petra held several senior commercial leadership positions at Bayer and Lilly.
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