Full Press Release Details
Outlook Therapeutics Announces UK Submission
of Marketing Authorization Application (MAA) for ONS-5010 as a Treatment for Wet AMD
ISELIN, N.J., May 13, 2024 - Outlook
Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve regulatory approval for the first authorized use of
an ophthalmic formulation of bevacizumab for the treatment of retinal diseases in the US and Europe, today announced the submission of
its Marketing Authorization Application (MAA) to the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom
(UK) seeking authorization of ONS-5010/LYTENAVA (bevacizumab gamma) for the treatment of wet age-related macular degeneration
The submission was completed under the new International
Recognition Procedure (IRP), which allows the MHRA to rely on a positive opinion by the European Medicines Agency's CHMP concerning
an application for grant of marketing authorization for the same product in the EU. The IRP is available for new UK MAAs of a medicinal
product (having the same qualitative and quantitative composition, and the same pharmaceutical form) that has previously been authorized
by a Reference Regulator (RR). In this case this is the EMA.
"The submission of our MAA to the MHRA
is another step closer to the possibility of offering clinicians and their patients in the UK market the only on-label, ophthalmic bevacizumab
to treat wet AMD," said Russell Trenary, President and CEO of Outlook Therapeutics. "On the heels of the recent positive
opinion by the CHMP in the EU, we continue to make noteworthy progress toward the potential authorization of ONS-5010/LYTENAVA
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.
As previously announced, Outlook Therapeutics
received a CHMP positive opinion on March 22, 2024 concerning an application for grant of marketing authorization for ONS-5010/LYTENAVA
in the EU. The European Commission is expected to make a decision within approximately 67 days following the CHMP opinion. The decision
will apply automatically in all 27 EU Member States, and, within 30 days, also to Iceland, Norway and Liechtenstein.
About ONS-5010 / LYTENAVA (bevacizumab-vikg,
ONS-5010/LYTENAVA 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 FDA or European Commission approved ophthalmic formulations of bevacizumab are currently available, clinicians wishing to
treat retinal patients with bevacizumab have had to use repackaged IV bevacizumab authorized for a different therapeutic indication and
provided by compounding pharmacies-products that have known risks of contamination and inconsistent potency and availability. If
approved, ONS-5010/LYTENAVA would provide an authorized option for physicians to treat wet AMD in the United States, EU and the
Bevacizumab-vikg (bevacizumab gamma in the EU
and UK) 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
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 achieve FDA, European Commission and MHRA approval for the launch of ONS-5010/LYTENAVA (bevacizumab-vikg or bevacizumab
gamma) as the first approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD, DME and BRVO. If
ONS-5010/Lytenava is approved, Outlook Therapeutics expects to commercialize it
as the first and only European Commission, MHRA or FDA approved ophthalmic formulation of bevacizumab for use in treating retinal diseases
in the United States, EU, and UK. Authorization may also be sought in other European markets, Japan, and other markets. As part of the
Outlook Therapeutics multi-year commercial planning process, Outlook Therapeutics and Cencora have entered into a strategic commercialization
agreement to expand Outlook Therapeutics' reach for connecting to retina specialists and their patients. Cencora will provide third-party
logistics (3PL) services and distribution, as well as pharmacovigilance services and other services in the United States, EU and UK.
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 "continue," "expect,"
"may," "plan," "possible," "potential," "will," or "would" the
negative of terms like these or other comparable terminology, and other words or terms of similar meaning. These include, among others,
ONS-5010's potential as the only on-label, ophthalmic bevacizumab to treat wet AMD for patients and clinicians in the UK market,
expectations concerning decisions of regulatory bodies, including the European Commission and the MHRA, and the timing thereof, expectations
concerning the relationship with Cencora and the benefits and potential expansion thereof, 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, the content and timing of decisions by the FDA, as well as those risks
detailed in Outlook Therapeutics' filings with the Securities and Exchange Commission (the SEC), including the Annual
Report on Form 10-K for the fiscal year ended September 30, 2023, filed with the SEC on December 22, 2023, and future
quarterly reports Outlook Therapeutics files with the SEC, which include uncertainty of market conditions and future impacts
related to macroeconomic factors, including as a result of the ongoing overseas conflicts, high interest rates, inflation and potential
future bank failures on the global business environment. 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.
Chief Executive Officer