Accueil / Communiqués / Newly-Formed Arvelle Therapeutics Acquires Exclusive Rights from SK Biopharmaceuticals to Develop and Commercialize Cenobamate in Europe

Newly-Formed Arvelle Therapeutics Acquires Exclusive Rights from SK Biopharmaceuticals to Develop and Commercialize Cenobamate in Europe

Thursday, February 14th 2019 at 8:00am UTC
  • Arvelle Therapeutics GmbH to provide SK Biopharmaceuticals an upfront
    payment of $100 million with future milestone potential of up to $430
    million
  • A new CNS-focused company, Arvelle received one of the largest initial
    financing commitments for a European-focused biopharmaceutical company
    from a global syndicate which includes NovaQuest Capital Management,
    Life Sciences Partners (LSP), BRV Capital Management, Andera Partners
    and H.I.G. BioHealth Partners
  • Global industry leader Mark Altmeyer named Arvelle President and CEO
  • Arvelle intends to file a Marketing Authorization Application (MAA)
    for cenobamate for partial-onset seizures in adults

BASEL, Switzerland–(BUSINESS WIRE)– SK Biopharmaceuticals and Arvelle Therapeutics GmbH today announced that
they have entered into an exclusive licensing agreement for Arvelle to
develop and commercialize cenobamate in Europe. Cenobamate is a novel,
small molecule investigational antiepileptic drug for the potential
treatment of partial-onset seizures in adult patients. 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 in addition to royalties
on net sales generated in Europe. SK Biopharmaceuticals will have an
option to obtain a significant equity stake in Arvelle and will also
retain commercial rights for all non-European territories. Cenobamate
was discovered and developed by SK Biopharmaceuticals from inception
through to the acceptance of a New Drug Application (NDA) by the U.S.
Food and Drug Administration (FDA).

“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. “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 Therapeutics 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 has been named President and
CEO of Arvelle. Altmeyer brings more than 30 years of global
biopharmaceutical experience to Arvelle. As President and CEO of Otsuka
America Pharmaceutical, Inc., Altmeyer oversaw the growth of Abilify®
into a multi-billion-dollar product. Most recently, he served as
President and Chief Commercial Officer of Axovant Sciences and
previously led the neuroscience business unit at Bristol-Myers Squibb
Company. Altmeyer is joined by a talented team of colleagues from
Axovant with deep experience in CNS drug development and global
commercialization. Arvelle intends to file a Marketing Authorization
Application (MAA) for cenobamate for partial-onset seizures in adult
patients based on the data generated from SK Biopharmaceuticals’ global
clinical trial program.

“We launched Arvelle to bring truly innovative CNS products to patients
suffering from serious neurological conditions and cenobamate is the
perfect first pipeline product,” said Altmeyer. “Given the data
generated in clinical trials and the FDA acceptance of the NDA, 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.”

“We are very excited to invest in the talented team at Arvelle on this
new venture,” said Martijn Kleijwegt, Managing Partner of LSP. “SK
Biopharmaceuticals has done an excellent job on the discovery and
development of cenobamate and we believe that Arvelle is the right
company to gain EU approval for cenobamate and ultimately bring it to
patients in Europe.”

About Cenobamate

Cenobamate (YKP3089) was discovered by SK Biopharmaceuticals and SK life
science and is being investigated for the potential treatment of
partial-onset seizures (also known as “focal seizures”) in adult
patients. 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.

Global trials for adults with partial-onset seizures are ongoing to
evaluate cenobamate safety. An additional clinical trial is
investigating cenobamate safety and efficacy for another form of
epilepsy in adult patients.

The U.S. Food and Drug Administration (FDA) accepted the filing of the
New Drug Application for cenobamate for the potential treatment of
partial-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 been
established.

About SK Biopharmaceuticals

SK Biopharmaceuticals is focused on research and development of
treatments for disorders of central nervous system (CNS) and cancer. SK
Biopharmaceuticals is an affiliate of SK Group, the second largest
conglomerate in Korea.

Currently, SK Biopharmaceuticals is conducting basic research for the
development of innovative new drugs at its research center in Pangyo,
Gyeonggi Province, Korea. Further, the company is pursuing global
clinical development and direct marketing through its U.S. subsidiary SK
Life Science, Inc., in Fair Lawn, New Jersey, USA.

SK Biopharmaceuticals has a pipeline of eight compounds in development
for the treatment of CNS disorders including epilepsy, sleep disorder
and attention deficit hyperactivity disorder, among others. The first
product the company is planning to commercialize, cenobamate (YKP3089),
is an investigational compound for the potential treatment of
partial-onset seizures in adult patients. The NDA for cenobamate for the
potential treatment of partial-onset seizures in adult patients is
currently under review by the FDA. For more information, visit SK
Biopharmaceuticals’ website at www.skbp.com/eng.

About Arvelle Therapeutics

Arvelle Therapeutics is a biopharmaceutical company with the mission of
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 one of the
largest initial financing commitments for a European-focused
biopharmaceutical company with investments from a global syndicate
including NovaQuest Capital Management, LSP, BRV Capital Management,
Andera Partners and H.I.G. BioHealth Partners. More information is
available at http://arvelletx.com/.

Contacts

For Arvelle Therapeutics:
Mike Beyer, Sam Brown Inc.
mikebeyer@sambrown.com
312-961-2502

Source: Arvelle Therapeutics


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