Axovant Announces Formation of Arvelle Therapeutics and Strategic Transition of Legacy Small Molecule Team Into Newly Formed ...
February 14 2019 - 6:00AM
Axovant Sciences (NASDAQ: AXGT), a clinical-stage company
developing innovative gene therapies, today announces the formation
of Arvelle Therapeutics and the strategic transition of its legacy
small molecule team into the newly-formed company.
Arvelle has licensed European rights to
cenobamate, a novel investigational anti-epileptic drug for the
potential treatment of focal (partial-onset) seizures, from SK
Biopharmaceuticals. Axovant will receive a 5% preferred equity
stake in Arvelle following the completion of the planned initial
capital raise of over $100 million from a global syndicate of
biotechnology investors.
SK Biopharmaceuticals filed a new drug
application (NDA) with the U.S. Food and Drug Administration (FDA)
in November 2018 and this filing was accepted by the agency in
February 2019, with a PDUFA date of November 21, 2019. Arvelle
plans to file a Marketing Authorization Application (MAA) based on
the data generated from SK Biopharmaceutical’s global clinical
trial program.
Axovant’s chief commercial officer Mark Altmeyer
will step down from his current role at Axovant to become president
and chief executive officer of Arvelle. Greg Weinhoff will remain
at Axovant as chief financial officer and transition to the role of
chief financial and business officer at Arvelle later in 2019. In
addition to receiving reimbursement for direct costs associated
with the creation of Arvelle, Axovant will reduce its headcount by
approximately 25% with the transition to Arvelle of employees with
expertise in small molecule development and commercialization and
the wind-down of other small molecule activities.
Axovant was involved in the origination,
diligence and structuring of the cenobamate license. Axovant is not
contributing any capital to the initial financing of Arvelle, and
the financing will be non-dilutive to Axovant’s shareholders.
“Throughout the past year, my goal at Axovant
was to build a strong pipeline and leadership team with a singular
focus on gene therapies. We learned about cenobamate last year as
we were defining the company’s new strategic direction, and we
formed a unique relationship with SK Biopharmaceuticals through
that process. The transition of Axovant’s small molecule
team to Arvelle completes our transformation into a company focused
exclusively on the development of innovative gene
therapies, while offering us an opportunity to reduce costs and
realize long-term value from our legacy small molecule platform,”
said Pavan Cheruvu, M.D., chief executive officer of Axovant. “We
wish Mark well in his new role, and are excited about the potential
for cenobamate to offer a new treatment option to millions of
patients suffering from epilepsy.”
About Axovant
Axovant Sciences is a clinical-stage gene therapy company
focused on developing a pipeline of innovative product candidates
for debilitating neurological and neuromuscular diseases. The
company’s current pipeline of gene therapy candidates targets GM1
gangliosidosis, GM2 gangliosidosis (including Tay-Sachs disease and
Sandhoff disease), Parkinson’s disease, oculopharyngeal muscular
dystrophy (OPMD), amyotrophic lateral sclerosis (ALS) and
frontotemporal dementia. Axovant is focused on accelerating product
candidates into and through clinical trials with a team of experts
in gene therapy development and through external partnerships with
leading gene therapy organizations. For more information, visit
www.axovant.com.
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.
Forward Looking Statements and
Information
This press release contains forward-looking
statements for the purposes of the safe harbor provisions under The
Private Securities Litigation Reform Act of 1995 and other federal
securities laws. The use of words such as “may,” “might,” “will,”
“expect,” “plan,” “anticipate,” “believe,” “intend,” “future,” or
“continue” and other similar expressions are intended to identify
forward-looking statements. For example, all statements Axovant
makes regarding the potential efficacy or safety of cenobamate;
the ability of Arvelle to advance its product candidates into
and successfully initiate, enroll, and complete clinical trials;
the timing or likelihood of Arvelle’s regulatory filings and
approvals; and Axovant’s ability to realize long term value of its
equity investment in Arvelle, are forward-looking. All
forward-looking statements are based on estimates and assumptions
by Axovant’s management that, although Axovant believes to be
reasonable, are inherently uncertain. All forward-looking
statements are subject to risks and uncertainties that may cause
actual results to differ materially from those that Axovant
expected. Such risks and uncertainties include, among others, the
initiation and conduct of preclinical studies and clinical trials;
the availability of data from clinical trials; the expectations for
regulatory submissions and approvals; and the availability or
commercial potential of product candidates. These statements are
also subject to a number of material risks and uncertainties that
are described in Axovant’s most recent Quarterly Report on Form
10-Q for the quarterly period ended December 31, 2018, filed with
the Securities and Exchange Commission on February 7, 2019, as
updated by its subsequent filings with the Securities and Exchange
Commission. Any forward-looking statement speaks only as of the
date on which it was made. Axovant undertakes no obligation to
publicly update or revise any forward-looking statement, whether as
a result of new information, future events or otherwise.
Contacts:
MediaMike BeyerSam Brown Inc.
(312) 961-2502mikebeyer@sambrown.commedia@axovant.com
InvestorsTricia
TruehartAxovant(631) 892-7014investors@axovant.com
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