Full Press Release Details
Outlook Therapeutics Announces Validation
of Marketing Authorization Application by the European Medicines Agency for ONS-5010 as a Treatment for Wet AMD
N.J., December 22, 2022 - 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.
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."
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
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.
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.
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.
LaVoie Health Science
Chief Executive Officer