Outlook Therapeutics® Receives European Union Positive CHMP Opinion for ONS-5010 as a Treatment for Wet AMD
Outlook Therapeutics (OTLK) receives positive opinion from CHMP for ONS-5010/LYTENAVA™ in the EU, a significant milestone in treating wet AMD.
The positive opinion from CHMP for Outlook Therapeutics' ONS-5010/LYTENAVA™ is a pivotal development in the company's trajectory, particularly considering the potential market exclusivity for a decade upon approval. This exclusivity could provide a significant competitive edge in the EU market for the treatment of wet AMD, a condition that is a leading cause of blindness in older adults. The anticipation of EC's decision within the stipulated 67 days could lead to increased investor interest, with potential impacts on the company's stock valuation.
Market exclusivity is a key driver for biopharmaceutical companies as it protects their investment in drug development and allows them to set prices without immediate generic competition. Given the prevalence of wet AMD and the aging population in Europe, the market potential for ONS-5010/LYTENAVA™ is substantial. However, the success of the product will also depend on the pricing strategy, reimbursement policies and the ability of the company to effectively commercialize the product, either directly or through partnerships.
Bevacizumab is already used off-label for the treatment of wet AMD, but ONS-5010/LYTENAVA™ represents the first ophthalmic formulation potentially approved for this indication, which may improve safety and efficacy profiles for patients. The clinical program's data, including the three registration trials, will have been rigorously evaluated by CHMP, indicating a strong scientific basis for the positive opinion.
It is important to note that while the positive opinion is a strong indicator of potential approval, the EC's final decision is pending. The approval would not only validate the efficacy and safety of the drug but also the robustness of the clinical program. The success of this drug could set a precedent for future ophthalmic drugs and influence research and development trends within the biopharmaceutical industry.
The financial implications for Outlook Therapeutics are multifaceted. The EC's impending decision could act as a catalyst for the company's stock, with positive investor sentiment potentially driving up the share price in the short term. Long-term financial success, however, hinges on the execution of a successful commercialization strategy and the ability to navigate the complex reimbursement landscape in Europe.
Investors should monitor the company's announcements regarding commercial partnerships, which could provide insight into the potential revenue streams and market penetration strategies. Additionally, the cost associated with the commercialization and any updates on projected sales figures will be critical for evaluating the company's future financial health and return on investment for shareholders.
03/22/2024 - 07:35 AM
Positive opinion serves as a basis for final decision for potential authorization from the European Commission (EC), expected within 67 days ISELIN, N.J., March 22, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve the first approval for an ophthalmic formulation of bevacizumab for the treatment of retinal diseases in the US and the EU, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion concerning the authorization of ONS-5010/LYTENAVA™ (bevacizumab gamma), an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD) in the EU. Outlook Therapeutics is assessing both direct commercialization of the product and partnering in Europe on a country-by-country basis.
“The CHMP positive opinion for ONS-5010/LYTENAVA™ represents a significant milestone for Outlook Therapeutics and advancement in the treatment of wet AMD in the EU. We are proud to be one step closer to bringing to the EU market the first and only on-label, ophthalmic bevacizumab for the treatment of wet AMD, if approved,” commented Russell Trenary, President and Chief Executive Officer.
The CHMP positive opinion was based on 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 well as studies and bibliographic literature substituting or supporting certain tests and studies. If approved, an initial ten years of market exclusivity in the European Union (EU) is expected for ONS-5010/LYTENAVA™.
The CHMP’s positive opinion supports the grant of marketing authorization by the European Commission (EC) for Outlook Therapeutics’ application for ONS-5010. The EC 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, bevacizumab gamma)
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 available currently, clinicians wishing to treat retinal patients with bevacizumab have had to use repackaged IV bevacizumab provided by compounding pharmacies—products that have known risks of contamination and inconsistent potency and availability. If approved, ONS-5010/LYTENAVA™ would provide an approved option for physicians to treat wet AMD.
Bevacizumab-vikg/bevacizumab gamma 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 achieve FDA and European Commission 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 ophthalmic bevacizumab is approved, Outlook Therapeutics expects to commercialize it as the first and only FDA and/or EC approved ophthalmic formulation of bevacizumab for use in treating retinal diseases in the United States, EU, United Kingdom, Europe, Japan, and other markets. As part of the Outlook Therapeutics' multi-year commercial planning process, Outlook Therapeutics and Cencora entered into a strategic commercialization agreement to expand the 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. 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,” “believe,” “continue,” “estimate,” “expect,” “intend,” “may,” “optimistic,” “plan,” “potential,” “target,” “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, statements about ONS-5010’s potential as the first ophthalmic formulation of bevacizumab-vikg for the treatment of retinal diseases in the US and EU, expectations concerning decisions of regulatory bodies, including the EC, and the timing thereof, plans for potential commercial launch of ONS-5010, 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 EC, 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 conflict, 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.
Investor Inquiries: OTLK@jtcir.com
What is the significance of the positive opinion from CHMP for Outlook Therapeutics (OTLK)?
The positive opinion from CHMP for ONS-5010/LYTENAVA™ in the EU marks a significant milestone for Outlook Therapeutics (OTLK) in advancing the treatment of wet AMD.
What is ONS-5010/LYTENAVA™ and its proposed use?
ONS-5010/LYTENAVA™ is an investigational ophthalmic formulation of bevacizumab proposed for treating wet age-related macular degeneration (wet AMD) in the EU.
What clinical trials supported the CHMP positive opinion for ONS-5010/LYTENAVA™?
The CHMP positive opinion for ONS-5010/LYTENAVA™ was based on results from Outlook Therapeutics' wet AMD clinical program, including NORSE ONE, NORSE TWO, and NORSE THREE trials.
What is the expected market exclusivity period for ONS-5010/LYTENAVA™ in the EU?
If approved, ONS-5010/LYTENAVA™ is expected to have an initial ten years of market exclusivity in the European Union (EU).
When is the decision expected from the European Commission (EC) regarding ONS-5010/LYTENAVA™?
The EC is expected to make a decision within approximately 67 days following the CHMP positive opinion for ONS-5010/LYTENAVA™.
