Sandoz confirms late-stage clinical development plans for proposed biosimilar aflibercept, a key ophthalmology medicine

• Sandoz to begin enrolling patients with neovascular age-related macular degeneration in MYLIGHT Phase lll confirmatory efficacy and safety study¹
• Neovascular age-related macular degeneration accounts for 10% of age-related macular degeneration cases, but is responsible for 90% of AMD-related blindness²
• With eight marketed biosimilar medicines globally and 15+ molecules in pipeline, Sandoz is investing in future of biosimilars for patients and healthcare systems
  
  

Holzkirchen, May 3, 2021 – Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly¹.

Aflibercept is indicated to improve visual acuity in patients with neovascular age-related macular degeneration (nAMD), diabetic macular oedema, macular oedema secondary to retinal vein occlusion, and other specific neovascular retinal diseases³.

“nAMD accounts for 10% of all age-related macular degeneration cases, but is responsible for 90% of AMD-related blindness²,” said Florian Bieber, Global Head of Biopharmaceuticals Development, Sandoz. “Aflibercept is a key treatment in ophthalmology. The initiation of this study marks an important milestone in the development of our biosimilar aflibercept. As with all our biosimilar programs, we aim to expand access to high-quality, more affordable biologics.”

MYLIGHT is part of a comprehensive biosimilar development program including analytical, preclinical and clinical data. The study aims to confirm that the proposed biosimilar has equivalent efficacy and comparable safety to the reference medicine* in patients with nAMD¹.

Sandoz biosimilars help patients to access advanced biologic medicines more sustainably and affordably. The Sandoz division has a leading global portfolio with eight marketed biosimilars and a further 15-plus in various stages of development. The Sandoz biosimilar pipeline is a blend of in-house development and collaborations, both for co-development and commercialization, targeting key biologics in oncology, immunology, endocrinology and underserved complex disease areas.

About aflibercept

Aflibercept binds and inhibits ocular VEGF-A, and prevents abnormal growth of blood vessels in the choroid which impact visual function. It improves visual acuity in patients with neovascular retinal diseases like nAMD, Diabetic macular edema (DME), and Retinal vein occlusion (RVO).

About MYLIGHT

The MYLIGHT is a randomized, double-blind, parallel 2-arm study, which is projected to include 460 patients across 20 countries. The MYLIGHT study will be conducted in neovascular (wet) age-related macular degeneration as this is an adequately sensitive indication and representative of many patients who are treated with the medicine.¹ nAMD patients will be randomized to receive either biosimilar aflibercept or the reference medicine for 48 weeks. The primary endpoint is the mean change in best corrected visual acuity (BCVA) score from baseline to week 8, using a standard test chart (EDTRS).

The global development program for Sandoz’ biosimilar aflibercept was developed in consultation with major regulatory agencies and the results from this clinical study are expected to support regulatory submissions.

*Eylea^® is a trademark of Bayer AG and in the US of Regeneron Pharmaceuticals, Inc.

Disclaimer

This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that, if approved, such generic or biosimilar products will be approved for all indications included in the reference product’s label. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; the particular prescribing preferences of physicians and patients; competition in general, including potential approval of additional generic or biosimilar versions of such products; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Sandoz from selling its products; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Sandoz

Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. Our purpose is to pioneer access for patients by developing and commercializing novel, affordable approaches that address unmet medical needs. Our ambition is to be the world’s leading and most valued generics company. Our broad portfolio of high-quality medicines, covering all major therapeutic areas, accounted for 2020 sales of USD 9.6 billion.

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References

1. Phase III Study Assessing the Efficacy, Safety and Immunogenicity of SOK583A1 Versus Eylea® in Patients With Neovascular Age-related Macular Degeneration (Mylight). Availabel from: https://clinicaltrials.gov/ct2/show/NCT04864834?term=CSOK583A12301&draw=2&rank=1. [Accessed April 2021]
2. Morris B, et al. Postgrad Med J 2007;83:301–307
3. Decision Resources Group, Clarivate. Dry and wet age-related macular degeneration. Disease Landscape and Forecast 2020. Available from: https://decisionresourcesgroup.com/report/sptoop0004-biopharma-dry-and-wet-age-related-macular-degeneration [Accessed April 2021]