Outlook Therapeutics® Announces NICE Recommendation of LYTENAVA™ (bevacizumab gamma) for the Treatment of Wet AMD
Outlook Therapeutics (OTLK) has received a positive recommendation from the National Institute for Health and Care Excellence (NICE) for LYTENAVA™ (bevacizumab gamma) in treating wet age-related macular degeneration (wet AMD). This marks the first positive reimbursement decision worldwide for LYTENAVA™.
The drug, which received regulatory approval in the EU and UK earlier this year, is the first and only approved ophthalmic formulation of bevacizumab for wet AMD treatment in these regions. It has secured 10 years of market exclusivity. The company anticipates its first commercial launch in H1 2025, with potential to benefit approximately 40,000 new wet AMD patients annually in the UK.
The recommendation applies to England and Wales, and follows LYTENAVA™'s Marketing Authorization by the UK MHRA. Outlook Therapeutics has partnered with Cencora for global commercial launch support.
Outlook Therapeutics (OTLK) ha ricevuto una raccomandazione positiva dal National Institute for Health and Care Excellence (NICE) per LYTENAVA™ (bevacizumab gamma) nel trattamento della degenerazione maculare legata all'età umida (wet AMD). Questo rappresenta la prima decisione positiva di rimborso a livello mondiale per LYTENAVA™.
Il farmaco, che ha ottenuto l'approvazione normativa nell'UE e nel Regno Unito all'inizio di quest'anno, è la prima e unica formulazione oftalmica approvata di bevacizumab per il trattamento della wet AMD in queste regioni. Ha garantito 10 anni di esclusività di mercato. L'azienda prevede di lanciare commercialmente il farmaco nella prima metà del 2025, con il potenziale di beneficiare circa 40.000 nuovi pazienti con wet AMD ogni anno nel Regno Unito.
La raccomandazione si applica a Inghilterra e Galles e segue l'Autorizzazione alla Commercializzazione di LYTENAVA™ da parte della MHRA del Regno Unito. Outlook Therapeutics ha collaborato con Cencora per il supporto al lancio commerciale globale.
Outlook Therapeutics (OTLK) ha recibido una recomendación positiva del National Institute for Health and Care Excellence (NICE) para LYTENAVA™ (bevacizumab gamma) en el tratamiento de la degeneración macular relacionada con la edad húmeda (wet AMD). Esto marca la primera decisión positiva de reembolso a nivel mundial para LYTENAVA™.
El fármaco, que recibió la aprobación regulatoria en la UE y el Reino Unido a principios de este año, es la primera y única formulación oftálmica aprobada de bevacizumab para el tratamiento de la wet AMD en estas regiones. Ha asegurado 10 años de exclusividad de mercado. La empresa anticipa su primer lanzamiento comercial en la primera mitad de 2025, con el potencial de beneficiar aproximadamente a 40,000 nuevos pacientes con wet AMD anualmente en el Reino Unido.
La recomendación se aplica a Inglaterra y Gales, y sigue a la Autorización de Comercialización de LYTENAVA™ por parte de la MHRA del Reino Unido. Outlook Therapeutics ha colaborado con Cencora para el apoyo al lanzamiento comercial global.
아웃룩 치료제(OTLK)는 LYTENAVA™ (베바시주맙 감마)가 습성 노인성 황반변성(습성 AMD) 치료에 대해 국민 보건 및 의료 우수성 연구소(NICE)로부터 긍정적인 권고를 받았다고 발표했습니다. 이는 LYTENAVA™에 대한 세계 최초의 긍정적인 상환 결정입니다.
올해 초 EU와 영국에서 규제 승인을 받은 이 약물은 이들 지역에서 습성 AMD 치료를 위한 베바시주맙의 첫 번째이자 유일한 승인된 안과 제형입니다. 이 약물은 시장에서 10년간의 독점 권리를 확보했습니다. 회사는 2025년 상반기 첫 상업 출시를 예상하고 있으며, 영국에서 매년 약 40,000명의 새로운 습성 AMD 환자에게 혜택을 줄 수 있는 잠재력을 가지고 있습니다.
이 추천은 잉글랜드와 웨일즈에 적용되며, 이는 영국 MHRA의 LYTENAVA™ 마케팅 허가 이후에 이루어졌습니다. 아웃룩 치료제는 세계 상업적 출시 지원을 위해 Cencora와 협력하고 있습니다.
Outlook Therapeutics (OTLK) a reçu une recommandation positive de l'Institut national pour la santé et l'excellence des soins (NICE) pour LYTENAVA™ (bevacizumab gamma) dans le traitement de la dégénérescence maculaire liée à l'âge humide (wet AMD). Cela marque la première décision positive de remboursement au monde pour LYTENAVA™.
Le médicament, qui a obtenu l'approbation réglementaire dans l'UE et le Royaume-Uni plus tôt cette année, est la première et unique formulation ophtalmique approuvée de bevacizumab pour le traitement de la wet AMD dans ces régions. Il a obtenu 10 ans d'exclusivité sur le marché. La société prévoit son premier lancement commercial dans la première moitié de 2025, avec le potentiel de bénéficier à environ 40 000 nouveaux patients atteints de wet AMD chaque année au Royaume-Uni.
La recommandation s'applique à l'Angleterre et au Pays de Galles, et fait suite à l'autorisation de mise sur le marché de LYTENAVA™ par la MHRA du Royaume-Uni. Outlook Therapeutics a établi un partenariat avec Cencora pour le soutien au lancement commercial mondial.
Outlook Therapeutics (OTLK) hat eine positive Empfehlung vom National Institute for Health and Care Excellence (NICE) für LYTENAVA™ (Bevacizumab Gamma) zur Behandlung der feuchten altersbedingten Makuladegeneration (feuchte AMD) erhalten. Dies markiert die erste positive Erstattungsentscheidung weltweit für LYTENAVA™.
Das Medikament, das zu Beginn dieses Jahres die regulatorische Genehmigung in der EU und im Vereinigten Königreich erhielt, ist die erste und einzige genehmigte ophthalmologische Formulierung von Bevacizumab zur Behandlung von feuchter AMD in diesen Regionen. Es hat 10 Jahre Marktexklusivität gesichert. Das Unternehmen anticipiert die erste kommerzielle Markteinführung in der ersten Hälfte von 2025, mit dem Potenzial, jährlich etwa 40.000 neuen Patienten mit feuchter AMD im Vereinigten Königreich zugutekommen.
Die Empfehlung gilt für England und Wales und folgt der Marktzulassung von LYTENAVA™ durch die MHRA im Vereinigten Königreich. Outlook Therapeutics hat sich mit Cencora zusammengetan, um globale Unterstützung für die Markteinführung zu bieten.
- First positive reimbursement decision worldwide for LYTENAVA™
- 10 years of market exclusivity in EU and UK
- Potential market of 40,000 new wet AMD patients annually in UK
- First and only approved ophthalmic formulation of bevacizumab for wet AMD in EU and UK
- Strategic partnership with Cencora for global distribution
- Commercial launch delayed until 2025
- Still pending pricing and reimbursement processes in EU countries
Insights
The NICE recommendation for LYTENAVA™ represents a significant milestone for Outlook Therapeutics, marking the first positive reimbursement decision worldwide. The approval in the UK market, with 40,000 new wet AMD patients annually, opens a substantial commercial opportunity. The 10-year market exclusivity provides a strong competitive advantage.
The NHS inclusion through NICE recommendation is particularly valuable as it ensures broad market access and establishes a precedent for other European markets. The strategic partnership with Cencora for distribution infrastructure demonstrates solid commercial preparation. The planned launch in H1 2025 allows adequate time for market preparation and pricing negotiations in other EU countries.
The cost-effectiveness emphasis in NICE's decision suggests favorable pricing dynamics that could drive adoption while maintaining healthy margins. This could serve as a benchmark for negotiations with other European healthcare systems.
LYTENAVA™'s approval as the first licensed ophthalmic formulation of bevacizumab represents a significant medical advancement. The standardization of bevacizumab for ophthalmic use addresses long-standing concerns about quality control in off-label applications. The robust clinical program, including three registration trials (NORSE ONE, TWO and THREE), provides strong efficacy validation.
The implementation of quality controls through the licensing process enhances safety profiles compared to previous off-label bevacizumab use. This approval could shift treatment paradigms in wet AMD management, particularly in markets where cost considerations influence treatment decisions. The formal approval pathway establishes a new standard for ophthalmic bevacizumab preparations, potentially influencing future drug development in this space.
First positive reimbursement decision worldwide for LYTENAVA™; First launch anticipated in H1 2025
LYTENAVA™ is the first and only approved ophthalmic formulation of bevacizumab for the treatment of wet AMD in the European Union (EU) and United Kingdom (UK)
40,000 new wet AMD patients each year in the UK who could benefit from treatment1
ISELIN, N.J., Dec. 04, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union and the United Kingdom earlier this year for LYTENAVA™ (bevacizumab gamma), the first ophthalmic formulation of bevacizumab authorized for the treatment of wet age-related macular degeneration (wet AMD) in adults, today announced that the National Institute for Health and Care Excellence (NICE) has recommended LYTENAVA™ (bevacizumab gamma), as an option for the treatment of wet AMD. LYTENAVA™ (bevacizumab gamma) is the first and only authorized ophthalmic formulation of bevacizumab for use in treating wet AMD in adults in the EU and UK and has an initial 10 years of market exclusivity.
“We are very pleased to receive the NICE recommendation of LYTENAVA™ (bevacizumab gamma) for patients with wet AMD. As the first positive reimbursement decision worldwide, this builds on our momentum and bolsters our commercialization strategy moving forward,” commented Jedd Comiskey, Senior Vice President, Head of Europe, of Outlook Therapeutics. “We remain committed to providing the UK health system with a cost effective treatment option for treating wet AMD. Looking ahead, our team continues preparations for commercial launch in the UK anticipated in 2025 and continues to work through the pricing and reimbursement processes for EU countries, with launches in the EU anticipated to follow.”
NICE is an executive non-departmental public body responsible for providing guidance on the promotion of good health and the prevention and treatment of ill health in the UK, considering clinical effectiveness and value for money. The NICE recommendation applies to England and Wales and follows the recent Marketing Authorization for LYTENAVA™ (bevacizumab gamma) for the treatment of wet AMD by the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA).
Professor Tim Jackson, PhD, FRCOphth, Consultant Ophthalmic Surgeon, King's College Hospital and Professor of Retinal Research, King’s College London, commented, “It is good news that bevacizumab gamma will be available for patients in England and Wales on the NHS. LYTENAVA™ (bevacizumab gamma) is the first licensed ophthalmic formulation of bevacizumab. Despite not previously being approved for ophthalmic use, bevacizumab has been widely used to treat wet-AMD outside the UK and the approval by NICE marks significant progress towards ophthalmologists being able to use licensed bevacizumab for wet AMD in the UK. Importantly, the licensing process puts in place a number of quality controls, and combined with reduced cost, this should provide a welcome, cost-effective treatment option for our patients.”
“The approval by NICE makes LYTENAVA™ (bevacizumab gamma) the first and only ophthalmic bevacizumab to be available on the NHS and for Independent Sector Providers, which is a stride in the right direction for the patients needing anti-VEGF treatments to control their wet AMD,” said Alexander Silvester, Chief Medical Officer, SpaMedica.
The positive NICE recommendation was based on results from Outlook Therapeutics’ wet AMD clinical program for ONS-5010 / LYTENAVA™, which consists of three completed registration clinical trials - NORSE ONE, NORSE TWO and NORSE THREE, as well as studies and peer reviewed literature substituting or supporting certain tests and studies.
As part of a multi-year planning process, Outlook Therapeutics entered a strategic collaboration with Cencora (formerly AmerisourceBergen) to support the commercial launch of LYTENAVA™ globally following regulatory approvals. The collaboration and integrated approach is designed to support market access and efficient distribution of LYTENAVA™ to benefit all stakeholders, including retina specialists, providers and patients.
About ONS-5010 / LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma)
ONS-5010/LYTENAVA™ is an ophthalmic formulation of bevacizumab for the treatment of wet AMD. LYTENAVA™ (bevacizumab gamma) is the subject of a centralized Marketing Authorization granted by the European Commission in the European Union (EU) and Marketing Authorization granted by the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) for the treatment of wet age-related macular degeneration (wet AMD).
In the United States, ONS-5010/LYTENAVA™ (bevacizumab-vikg) is investigational and is being evaluated in an ongoing non-inferiority study for the treatment of wet AMD.
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 focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma), for the treatment of retina diseases, including wet AMD. LYTENAVA™ (bevacizumab gamma) is the first ophthalmic formulation of bevacizumab to receive European Commission and MHRA Marketing Authorization for the treatment of wet AMD. Outlook Therapeutics is working to initiate its commercial launch of LYTENAVA™ (bevacizumab gamma) in the EU and the UK as a treatment for wet AMD, expected in the first half of calendar 2025. In the United States, ONS-5010/LYTENAVA™ is investigational, is being evaluated in an ongoing non-inferiority study for the treatment of wet AMD, and if successful, the data may be sufficient for Outlook to resubmit a BLA to the FDA in the United States. If approved in the United States, ONS-5010/LYTENAVA™, would be the first approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD.
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,” “continue,” “expect,” “may,” “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, plans for commercial launch of LYTENAVA™ in the UK and EU and timing thereof, Outlook Therapeutics’ commercialization strategy, the therapeutic potential of LYTENAVA™ as a treatment of wet AMD, the expected cost effectiveness of LYTENAVA™ in the UK, expectations concerning the relationship with Cencora, the benefits thereof and the services to be provided thereunder, ONS-5010’s potential as the first FDA-approved ophthalmic formulation of bevacizumab for use in treating retinal indications, including wet AMD, in the United States, expectations concerning Outlook Therapeutics’ ability to remediate or otherwise resolve deficiencies identified in the CRL issued by the FDA, including plans to resubmit the BLA for ONS-5010, expectations concerning decisions of regulatory bodies and the timing 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 and commercializing pharmaceutical product candidates, risks of conducting clinical trials and risks in obtaining necessary regulatory approvals, the content and timing of decisions by regulatory bodies, the sufficiency of Outlook Therapeutics’ resources, 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.
Investor Inquiries:
Jenene Thomas
Chief Executive Officer
JTC Team, LLC
T: 908.824.0775
OTLK@jtcir.com
Media Inquiries:
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Senior Account Executive
Hanover Communications
T: +44 7738 832195
eblundell@hanovercommunications.com
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