• Appoints Petra Molan as Senior Vice President Commercial and Enrico Dolfini as Vice President Legal Counsel
  • Full leadership team now in place ahead of planned Marketing Authorization Application submission for cenobamate in Europe in H1 2020

Zug, Switzerland, October 31, 2019 – Arvelle Therapeutics GmbH (“Arvelle”), an emerging biopharmaceutical company focused on bringing innovative treatments to patients suffering from CNS disorders, today announces that Petra Molan has been appointed as Senior Vice President Commercial, effective from November 1, 2019, and Enrico Dolfini as Vice President Legal Counsel, effective from December 2, 2019.

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.

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.

Petra and Enrico will be based in Arvelle’s office in Zug, Switzerland and will oversee the Company’s commercial and legal operations, including preparation and implementation of the Company’s future commercial strategy for lead product, cenobamate, ahead of the planned marketing authorization application (MAA) submission for Europe in H1 2020.

Mark Altmeyer, President and CEO of Arvelle Therapeutics, said: 

I am delighted to welcome Petra and Enrico to Arvelle at this important time in the Company’s development. Petra’s vast commercial knowledge, alongside Enrico’s expert legal guidance, will be invaluable to the Company ahead of the planned MAA submission for cenobamate in H1 2020, and beyond, as we look towards subsequent launch in Europe. I would like to welcome Petra and Enrico to the team and look forward to working with them.

Since establishing its office in Zug, earlier this year, Arvelle has also appointed a number of department heads including:

Commenting on her appointment, Petra Molan said: 

Epilepsy is one of the most common neurological disorders worldwide and there is a pressing need for new, effective, drugs. We believe cenobamate has the potential to reduce the frequency and severity of seizures in adults with focal-onset seizures and I am excited to work with the team at Arvelle during the approval process and hope to bring it to the market for patients across Europe.

  • VP Regulatory: Nadia Assenova
  • VP Medical Affairs: Elena Alvarez-Baron
  • VP Human Resources: Luca Rota
  • VP Finance: Hans Hubregtse
  • VP Market Access and Pricing: Jasmina Medjedovic

With these appointments now in place, Arvelle has assembled a strong and complete leadership team to support the planned MAA submission and subsequent planned launch of cenobamate across Europe.

For more information please contact:

Arvelle Therapeutics
Email: Juan.Vergez@arvelletx.com

Consilum Strategic Communications (international strategic communications)
Mary-Jane Elliott/Susan Stuart/Alex Harrison/Lindsey Neville
Email: arvelletherapeutics@consilium-comms.com
Telephone: +44 (0)20 3709 5700

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 and received 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, LSP, H.I.G. BioHealth Partners, Andera Partners, F-Prime Capital and KB Investment. More information is available at http://Arvelletx.com

About Cenobamate

Cenobamate (YKP3089) was discovered by SK Biopharmaceuticals and SK life science and is being investigated for the potential treatment of focal-onset seizures (previously known as partial-onset seizures) in adult patients with epilepsy. Cenobamate’s mechanism of action is not fully elucidated, 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.

Global trials for adults with focal‐onset seizures are ongoing to evaluate cenobamate safety. An additional clinical trial is investigating cenobamate safety and efficacy in adults with primary generalized epilepsy (ClinicalTrials.gov Identifier: NCT03678753).

The U.S. Food and Drug Administration (FDA) accepted the filing of the New Drug Application for cenobamate for the potential treatment of focal-onset seizures in adults in February 2019. Cenobamate is not approved by the FDA, European Medicines Agency (EMA) or any other regulatory authorities. Safety and efficacy have not yet been established.