Outlook Therapeutics® Announces Validation of Marketing Authorization Application by the European Medicines Agency for ONS-5010 as a Treatment for Wet AMD
December 22 2022 - 08:05AM
Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical
company working to develop and launch the first FDA-approved
ophthalmic formulation of bevacizumab for use in retinal
indications, today announced the validation of its Marketing
Authorization Application (MAA) by the European Medicines Agency
(EMA) for ONS-5010 / LYTENAVA™ (bevacizumab-vikg), an
investigational ophthalmic formulation of bevacizumab for the
treatment of wet age-related macular degeneration (wet AMD). The
formal review process of the MAA by the EMA’s Committee for
Medicinal Products for Human Use (CHMP) is now set to begin with an
estimated decision date expected in early 2024.
“The validation of our MAA by the EMA is another
exciting moment for our team in 2022 and takes us one step closer
to offering clinicians and their patients the first and only
on-label, ophthalmic bevacizumab to treat wet AMD,” said Russell
Trenary, President and CEO of Outlook Therapeutics. “In addition to
the recent acceptance of our BLA by the U.S. FDA and our continued
progress toward commercial launch, pending approval, we believe
ONS-5010 is well-positioned to provide a preferred treatment option
for the retina community and enhance the standard of care in the
anti-VEGF space.”
The MAA submission is supported by results from
Outlook Therapeutics’ wet AMD clinical program for ONS-5010, which
consists of three completed registration clinical trials - NORSE
ONE, NORSE TWO and NORSE THREE. If approved, an initial eight years
of regulatory exclusivity in the European Union (EU) is expected
for ONS-5010 in wet AMD. The regulatory exclusivity for ONS-5010
could potentially be increased by an additional two years if
Outlook Therapeutics pursues approvals for additional indications.
Outlook Therapeutics is assessing both direct commercialization and
partnering in Europe on a country-by-country basis
“This is a significant milestone as we continue
to execute on our development strategy and position ONS-5010 as a
much-needed therapeutic option to treat retinal diseases. We are
grateful to the team of European experts with whom we closely
collaborated to create what we believe is a high-quality dossier
for submission that can be used for further regulatory evaluation
processes in other regions globally,” added Terry Dagnon, Chief
Operations Officer of Outlook Therapeutics. “We look forward to
working with the EMA and our team of European experts throughout
the review process.” About ONS-5010 / LYTENAVA™
(bevacizumab-vikg) ONS-5010 is an
investigational ophthalmic formulation of bevacizumab under
development as an intravitreal injection for the treatment of wet
AMD and other retinal diseases. Because no currently approved
ophthalmic formulations of bevacizumab are available, clinicians
wishing to treat retinal patients with bevacizumab have had to use
unapproved repackaged IV bevacizumab provided by compounding
pharmacies, products that have known risks of contamination and
inconsistent potency and availability. If approved, ONS-5010 can
replace the need to use unapproved repackaged oncologic IV
bevacizumab from compounding pharmacies for the treatment of wet
AMD. Bevacizumab-vikg is a recombinant humanized
monoclonal antibody (mAb) that selectively binds with high affinity
to all isoforms of human vascular endothelial growth factor (VEGF)
and neutralizes VEGF’s biologic activity through a steric blocking
of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR
(VEGFR-2) on the surface of endothelial cells. Following
intravitreal injection, the binding of bevacizumab-vikg to VEGF
prevents the interaction of VEGF with its receptors on the surface
of endothelial cells, reducing endothelial cell proliferation,
vascular leakage, and new blood vessel formation in the
retina.
About Outlook Therapeutics, Inc.
Outlook Therapeutics is a biopharmaceutical
company working to develop and launch ONS-5010/ LYTENAVA™
(bevacizumab-vikg) as the first FDA-approved ophthalmic formulation
of bevacizumab for use in retinal indications, including wet AMD,
DME and BRVO. The FDA accepted Outlook Therapeutics’ BLA submission
for ONS-5010 to treat wet AMD with a PDUFA goal date of August 29,
2023. The submission is supported by Outlook Therapeutics’ wet AMD
clinical program, which consists of three clinical trials: NORSE
ONE, NORSE TWO, and NORSE THREE. If ONS-5010 ophthalmic bevacizumab
is approved, Outlook Therapeutics expects to commercialize it as
the first and only FDA-approved ophthalmic formulation of
bevacizumab for use in treating retinal diseases in the United
States, United Kingdom, Europe, Japan, and other markets. As part
of the Company’s multi-year commercial planning process, and in
anticipation of potential FDA approval in August 2023, Outlook
Therapeutics and AmerisourceBergen have entered into a strategic
commercialization agreement to expand the Company’s reach for
connecting to retina specialists and their patients.
AmerisourceBergen will provide third-party logistics (3PL) services
and distribution, as well as pharmacovigilance services in the
United States. For more information, please
visit www.outlooktherapeutics.com.
Forward-Looking Statements
This press release contains forward-looking statements. All
statements other than statements of historical facts are
“forward-looking statements,” including those relating to future
events. In some cases, you can identify forward-looking statements
by terminology such as “anticipate,” “estimate,” “expect,”
“intend,” “look forward,” “may,” “might,” “plan,” “potential,”
“predict,” “project,” “should,” “will,” the negative of terms like
these or other comparable terminology, and other words or terms of
similar meaning. These include, among others, statements about
ONS-5010’s potential as the first FDA-approved ophthalmic
formulation of bevacizumab-vikg, the timing of potential approval
decision by the EMA, expectations concerning market exclusivity,
the services to be provided under Outlook’s partnership with
AmerisourceBergen and the anticipated benefits thereof,
expectations regarding a commercial launch of ONS-5010, plans for
regulatory submissions and potential launch in international
markets, and other statements that are not historical fact.
Although Outlook Therapeutics believes that it has a
reasonable basis for the forward-looking statements contained
herein, they are based on current expectations about future events
affecting Outlook Therapeutics and are subject to risks,
uncertainties and factors relating to its operations and business
environment, all of which are difficult to predict and many of
which are beyond its control. These risk factors include those
risks associated with developing pharmaceutical product candidates,
risks of conducting clinical trials and risks in obtaining
necessary regulatory approvals, as well as those risks detailed in
Outlook Therapeutics’ filings with the Securities and Exchange
Commission, including the Annual Report on Form 10-K for the fiscal
year ended September 30, 2021, as supplemented by its
Quarterly Report on Form 10-Q for the quarter ended June 30,
2022, which include the uncertainty of future impacts related to
the ongoing COVID-19 pandemic and other macroeconomic factors.
These risks may cause actual results to differ materially from
those expressed or implied by forward-looking statements in this
press release. All forward-looking statements included in this
press release are expressly qualified in their entirety by the
foregoing cautionary statements. You are cautioned not to place
undue reliance on these forward-looking statements, which speak
only as of the date hereof. Outlook Therapeutics does not
undertake any obligation to update, amend or clarify these
forward-looking statements whether as a result of new information,
future events or otherwise, except as may be required under
applicable securities law.
CONTACTS:Media Inquiries:Anna
ArmyAccount SupervisorLaVoie Health ScienceT:
617-351-0246aarmy@lavoiehealthscience.com
Investor Inquiries:Jenene ThomasChief Executive
OfficerJTC Team, LLCT: 833.475.8247OTLK@jtcir.com
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