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Sandoz Group AG

ISIN: CH1243598427

WKN: A3ETYB

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Sandoz Group AG · ISIN: CH1243598427 · Newswire (adhoc)

Country: Schweiz · Primary market: Switzerland · EQS NID: 2194330

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09 September 2025 07:00AM

Sandoz reaches agreement with Regeneron, resolving all patent litigation related to its US aflibercept biosimilar

Sandoz Group AG / Key word(s): Agreement
Sandoz reaches agreement with Regeneron, resolving all patent litigation related to its US aflibercept biosimilar

09-Sep-2025 / 07:00 CET/CEST
Release of an ad hoc announcement pursuant to Art. 53 LR
The issuer is solely responsible for the content of this announcement.

Ad-hoc announcement pursuant to art. 53 SIX Swiss Exchange Listing Rules

Agreement clears path for launch of Enzeevu™ (aflibercept-abzv) by end of 2026
Enzeevu™ is an FDA-approved Sandoz biosimilar to Eylea^®
Anticipated launch further strengthens Sandoz biosimilar portfolio, advances growth strategy in US and ensures more patients have access to this affordable medicine

Basel, September 9, 2025 – Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, today announced that it has reached an agreement with Regeneron Pharmaceuticals, Inc. (Regeneron), to resolve all patent disputes between the two companies relating to the US Food and Drug Administration (FDA)-approved Sandoz aflibercept biosimilar.

Patent infringement proceedings were initially filed by Regeneron in the US Federal District Court for the District of New Jersey in August of 2024, pursuant to the Biologics Price Competition and Innovation Act (BPCIA). Resolution of the BPCIA litigation followed months of vigorous defense by Sandoz against claims by Regeneron that the company infringed up to 46 patents expiring as late as 2040, protecting reference medicine Eylea^®. Under the terms of the agreement, Sandoz may enter the US market with a biosimilar version of Eylea^® in the fourth quarter of 2026, or earlier in certain circumstances.

Sandoz received FDA approval of its aflibercept biosimilar Enzeevu™ on August 12, 2024. It has the same dosage form, route of administration, and presentation as the reference medicine. In addition, the FDA provisionally determined Enzeevu™ would be interchangeable with the reference medicine, as it is currently subject to an unexpired exclusivity for the first interchangeable biosimilar products.

Bringing biosimilar aflibercept to market further strengthens Sandoz leadership in ophthalmology in the US, expands its biosimilar portfolio, and advances the company’s Purpose of pioneering access for patients, by providing affordable high-quality medicines.

About Enzeevu™ (aflibercept-abzv)
Enzeevu™ (aflibercept-abzv) 2 mg vial kit and pre-filled syringe for intravitreal injection is indicated to improve and maintain visual acuity in patients with neovascular age-related macular degeneration (nAMD).[1] In addition, the FDA provisionally determined Enzeevu™ would be interchangeable with the reference medicine, as it is currently subject to an unexpired exclusivity for the first interchangeable biosimilar products.

nAMD, also known as wet AMD, is a subtype of age-related macular degeneration (AMD), which is a leading cause of vision impairment in patients 50 years of age or older in North America.[2]

The active ingredient in Enzeevu™ is aflibercept. Aflibercept is a recombinant fusion protein that binds to vascular endothelial growth factor A (VEGF-A) and placental growth factor (PlGF), inhibiting abnormal vessel growth. In patients with neovascular age-related macular degeneration (nAMD), aflibercept is injected into the eye to improve visual acuity and inhibit disease progression.

SELECT IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
Ocular or periocular infection
Active intraocular inflammation
Hypersensitivity

WARNINGS AND PRECAUTIONS
Endophthalmitis, retinal detachments, and retinal vasculitis with or without occlusion may occur following intravitreal injections. Patients and/or caregivers should be instructed to report any signs and/or symptoms suggestive of endophthalmitis, retinal detachment, or retinal vasculitis without delay and should be managed appropriately.

Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection.

There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors.

ADVERSE REACTIONS
The most common adverse reactions (≥5%) reported in patients receiving aflibercept were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and intraocular pressure increased.

This is not the complete list of all the safety information for Enzeevu™. Please see full Prescription Info for Enzeevu™.

REFERENCES
[1] Enzeevu™. Prescribing Information. Available at:
https://prod.cms.us.sandoz.com/sites/spare37_sandoz_com/files/Media%20Documents/ENZEEVU_PI_2024_2.pdf [Last accessed: August 2025]
[2] American Academy of Ophthalmology^®. Age-related macular degeneration (AMD). Available at:
https://www.aao.org/eye-health/diseases/amd-macular-degeneration [Last accessed: August 2025]

*Eylea^® is a registered trademark of Regeneron Pharmaceuticals, Inc.

DISCLAIMER
This Media Release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly revise any forward-looking statements, except as required by law.

ABOUT SANDOZ
Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in generic and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure 900 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006. In 2024, Sandoz recorded net sales of USD 10.4 billion.

<div> <p><span><span><span><strong>CONTACTS</strong></span></span></span></p> <table cellpadding="0" cellspacing="0" width="100%"><tbody><tr><td style="vertical-align: middle; width: 55%;"> <p><span><span><span><strong>Global Media Relations contacts</strong></span></span></span></p> </td> <td style="vertical-align: top; width: 50%;"> <p><span><span><span><strong>Investor Relations contacts</strong></span></span></span></p> </td> </tr><tr><td style="vertical-align: middle; width: 55%;"> <p><a href="mailto:Global.MediaRelations@sandoz.com" style="text-decoration: none;"><span><span><span><strong>Global.MediaRelations@sandoz.com</strong></span></span></span></a></p> </td> <td style="vertical-align: top; width: 50%;"> <p><a href="mailto:Investor.Relations@sandoz.com" style="text-decoration: none;"><span><span><span><strong>Investor.Relations@sandoz.com</strong></span></span></span></a></p> </td> </tr><tr><td style="vertical-align: middle; width: 55%;"> <p><span><span>Alex Kalomparis </span></span></p> <p><span><span>+41 792 790285 </span></span></p> </td> <td style="vertical-align: top; width: 50%;"> <p><span><span>Craig Marks </span></span></p> <p><span><span>+44 7818 942 383</span></span></p> </td> </tr><tr><td style="vertical-align: middle; width: 55%;"> <p><span><span>Joerg E. 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width: 50%;"> </td> </tr></tbody></table></div> </div><div id="461e4381-e6f3-4d6d-87bd-0d465d47a8d8" markup="footer"><p><a href="https://eqs-cockpit.com/cgi-bin/fncls.ssp?fn=redirect&url=674f3fde9918067d035465b35fbfb925&application_id=2194330&site_id=boersengefluester~~~ace3d64b-2049-452a-8d18-fbc8044c4b5f&application_name=news" style="text-decoration: none;"><span><span>Media release (PDF)</span></span></a></p> </div></div> <br/><hr/>End of Inside Information<hr/></td> </tr></table><table cellpadding="0" cellspacing="0"><tr><td align="left" valign="top" nowrap="nowrap">Language:</td> <td align="left" valign="top">English</td> </tr><tr><td align="left" valign="top" nowrap="nowrap">Company:</td> <td align="left" valign="top">Sandoz Group AG</td> </tr><tr><td align="left" valign="top"/> <td align="left" valign="top">Centralbahnstrasse 4</td> </tr><tr><td align="left" valign="top"/> <td align="left" valign="top">4051 Basel</td> </tr><tr><td align="left" valign="top"/> <td align="left" valign="top">Switzerland</td> </tr><tr><td align="left" valign="top" nowrap="nowrap">Internet:</td> <td align="left" valign="top">www.sandoz.com</td> </tr><tr><td align="left" valign="top" nowrap="nowrap">ISIN:</td> <td align="left" valign="top">CH1243598427</td> </tr><tr><td align="left" valign="top" nowrap="nowrap">Valor:</td> <td align="left" valign="top">124359842</td> </tr><tr><td align="left" valign="top">Listed:</td> <td align="left" valign="top">SIX Swiss Exchange</td> </tr><tr><td align="left" valign="top" nowrap="nowrap">EQS News ID:</td> <td align="left" valign="top">2194330</td> </tr></table><br/><table border="0" cellpadding="0" cellspacing="0"><tr><td align="left" valign="top" colspan="2"/> </tr></table><table border="0" cellpadding="0" cellspacing="0"><tr><td align="left" valign="top" colspan="2"> </td> </tr><tr><td align="left" valign="top">End of Announcement</td> <td align="left" valign="top">EQS News Service</td> </tr></table><table border="0" width="600" cellpadding="0" cellspacing="0"><tr><td> <hr/></td> </tr></table><p> 2194330 09-Sep-2025 CET/CEST </p> <img src="https://eqs-cockpit.com/cgi-bin/fncls.ssp?fn=show_t_gif&application_id=2194330&application_name=news&site_id=boersengefluester~~~ace3d64b-2049-452a-8d18-fbc8044c4b5f" alt="" width="0" height="0" border="0"/> </div> <div class="mt-4"> <div style="height: 400px;" class="position-relative"> <div class="tradingview-widget-container position-relative"> <div class="tradingview-widget-container__widget"></div> <div class="tradingview-widget-copyright" style="color: white !important;"> <a href="https://www.tradingview.com/symbols/SIX:SDZ/" rel="noopener" target="_blank" style="color: white !important;"> <span class="">SIX:SDZ price</span> </a> by TradingView </div> <script type="text/javascript" src="https://s3.tradingview.com/external-embedding/embed-widget-mini-symbol-overview.js" async>{"symbol":"SIX:SDZ","width":"100%","height":"100%","locale":"en","dateRange":"ALL","colorTheme":"dark","trendLineColor":"rgba(41, 98, 255, 1)","underLineColor":"rgba(41, 98, 255, 0.3)","underLineBottomColor":"rgba(41, 98, 255, 0)","isTransparent":true,"autosize":true}</script> </div> <div class="position-absolute w-100 h-100" style="top: 0px; 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The index is a rules-based strategy that seeks to track the total return of the SPDR® Technology XLK ETF, with investment exposure to the Underlying ETF adjusted for a targeted annual volatility rate of 30%."> <a href="https://ayondo.com/en/technical-analysis/US87166N7839" class="d-block" target="_blank"> <div class="spdr-widget-sector" style="--spdr-sector-color-scheme: #843382;"> XLK </div> </a> </div> <div class="col-auto" data-bs-toggle="tooltip" data-bs-placement="bottom" data-bs-title="WEBs Defined Volatility Sector ETF - in a nutshell: The index is a rules-based strategy that seeks to track the total return of the SPDR® Communications XLC ETF, with investment exposure to the Underlying ETF adjusted for a targeted annual volatility rate of 30%."> <a href="https://ayondo.com/en/technical-analysis/US87166N7755" class="d-block" target="_blank"> <div class="spdr-widget-sector" style="--spdr-sector-color-scheme: #9c6f99;"> XLC </div> </a> </div> <div class="col-auto" data-bs-toggle="tooltip" data-bs-placement="bottom" data-bs-title="WEBs Defined Volatility Sector ETF - in a nutshell: The Fund is a passively managed ETF that seeks to achieve the investment results of the Syntax Defined Volatility Industrials Index. The index is a rules-based strategy that seeks to track the total return of the SPDR® Industrials XLI ETF, with investment exposure to the Underlying ETF adjusted for a targeted annual volatility rate of 25%."> <a href="https://ayondo.com/en/technical-analysis/US87166N8415" class="d-block" target="_blank"> <div class="spdr-widget-sector" style="--spdr-sector-color-scheme: #92c5df;"> XLI </div> </a> </div> <div class="col-auto" data-bs-toggle="tooltip" data-bs-placement="bottom" data-bs-title="WEBs Defined Volatility Sector ETF - in a nutshell: The Fund is a passively managed ETF that seeks to achieve the investment results of the Syntax Defined Volatility Real Estate Index. The index is a rules-based strategy that seeks to track the total return of the SPDR® Real Estate XLRE ETF, with investment exposure to the Underlying ETF adjusted for a targeted annual volatility rate of 25%."> <a href="https://ayondo.com/en/technical-analysis/US87166N7599" class="d-block" target="_blank"> <div class="spdr-widget-sector" style="--spdr-sector-color-scheme: #8c2b28;"> XLRE </div> </a> </div> </div> <div class="text-center text-muted"> © 2025 WEBs Investments ETFs </div> </div> <div class="row mt-5 d-flex justify-content-end"> <div class="col-md-3"> <div class="text-end text-muted small mb-1 opacity-50"> Member of 3R/RSQ Network </div> <div class=" text-center mb-1"> <div class="border border-primary py-1" style="letter-spacing: 2px;"> Digital Content </div> <a href="#" class="text-reset text-decoration-none" target="_blank" data-bs-toggle="tooltip" data-bs-placement="bottom" data-bs-title="Digital Content Network Alliance"> <div class="border border-primary border-top-0 py-1 bg-primary text-white shake-hover" style="letter-spacing: 2px;"> Network Alliance </div> </a> </div> <div class="text-end text-muted small opacity-50"> Transparency - Reliability - Credibility </div> </div> </div> <div class="text-end text-muted mt-5"> Information regarding Product Information </div> <div class="mb-2"> <span id="info-today">Saturday, 13.09.2025,</span> Calendar Week 37, <span id="info-day-of-year">256th day of the year</span>, <span id="info-day-remaining">109 days remaining until EoY.</span> </div> <div class="mb-2"> <img src="https://app.feingold-research.com/uploads/logo/feingold-footer-logo.png" alt="" class="img-fluid" style="max-width: 225px;"> </div> </div> <footer class="position-relative"> <div class="bg-blue-secondary py-1"> <div class="container text-center text-blue-secondary"> #FGLD <sup>app</sup> | Innovation matters · A 3R/RSQ Technology Venture </div> </div> <div class="bg-primary"> <div class="container py-4"> <div class="text-end text-blue-secondary"> WebStat-Tracker: 4.731 Visitor (24h) </div> </div> </div> <div class="position-absolute w-100 animate__animated animate__fadeInUp" style="bottom: 40px; display: none;" id="footer-overlay"> <div class="info-bar-ad info-bar-ad-blue card-remove-p-margin-bottom p-2" style="border-bottom-width: 5px;"> <div class="container position-relative"> <div id="overlay-footer-about" style="display: none;" class="overlay-footer-content"> <div class="mb-3"> <i class="fas fa-info-circle h4 mb-0 me-2"></i> <span class="h4 mb-0 text-decoration-underline"> FGLD <sup>app</sup> </span> </div> <div> <p>FGLD <sup>app</sup> (via feingold-research.com/*.de) is a digital information service for investors with an affinity for the stock market that obtains information from a variety of different sources, intelligently links them together and makes them available to interested parties free of charge for further use. 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Fabian John (<a href="https://www.linkedin.com/in/gotojohn/">LinkedIn</a>)</p><hr><p>RSQ Technology Ventures GmbH ("RSQ") is responsible for the content accessible via the online portal in accordance with Section 55 (2) RStV.</p><p>Responsible according to § 55 Abs. 2 S. 1 RStV:<br>Fabian John<br><br>E-Mail: compliance@rsqtv.com<br><br>Data protection officer:<br>Fabian John<br><br>Email: privacy@rsqtv.com</p><hr><p>Compliance: compliance@rsqtv.com</p><p>Media, Sales, Marketing: p.inq@rsqtv.com</p><p>Cooperations: c.inq@rsqtv.com</p><hr><p>Information & technology design: concept, development, provision, operation:</p><p>IT & software development 3R technologies<br>I: 3r-tec.com</p><p>Project developer | project management:</p><p>Corporate consultancy 3RMCN<br>I: 3rmcn.com</p><p>CyberSecurity & Protection:</p><p>Proteo Defence AB</p><p>FGLD<sup>app</sup> is a project joint venture that was designed as a financial information portal and is aimed at all stakeholders who can interpret and evaluate the information provided. The information is aimed at investors with an affinity for the stock market and risk, as well as journalists and research departments who are interested in the latest news and further research opportunities for listed companies.</p><p>The feingold-research.com website is made available to users free of charge.</p><p>The information offering and the associated technological implementation concept were developed in a joint project. The technology used is based on a highly developed grey label concept, a proprietary technology asset developed on behalf of RSQ and used in various online portals.</p><p><img src="https://app.feingold-research.com/public/uploads/adverts/i/fgld/fgld_white.svg"></p><p><strong>Information on activities requiring a license</strong></p><p>Insofar as RSQ Technology Ventures GmbH ("RSQ") provides investment brokerage services within the meaning of Section 2 (2) No. 3 WpIG, it acts as a tied agent ("vgV") pursuant to Section 3 (2) WpIG. RSQ acts exclusively for the account and under the liability of DonauCapital Wertpapier GmbH, Passauer Str. 5, 94161 Ruderting. The client's contractual partner is DonauCapital Wertpapier GmbH.<br><br>RSQ Technology Ventures GmbH is entered in the public register kept on the Internet by the Federal Financial Supervisory Authority (BaFin) as a contractually bound intermediary of DonauCapital Wertpapier GmbH. The register can be viewed at <a href="https://portal.mvp.bafin.de/database/VGVInfo/vermittler.do?cmd=unternehmenZuVermittlerAction&id=-160355518">www.bafin.de</a>.<br> </p><p><strong>Information on the liability umbrella</strong></p><p>DonauCapital Wertpapier GmbH<br>Passauer Str. 5<br>94161 Ruderting<br>Managing Directors: Roland Wagner, Kurt Ziegler<br>Tel.: +49 (0)8509-910955<br>Fax: +49 (0)8509-910917<br>Internet: www.donaucapital.com<br>Email: wagner'at'donaucapital.com or ziegler'at'donaucapital.com <br><br>Register court: Munich Local Court, HRB 221691<br>St.-No.: 153/124/70796<br>Responsible according to § 55 Abs. 2 RStV: Kurt Ziegler<br><br><strong>Information on regulation</strong></p><p>Regulatory authority<br>Bundesanstalt für Finanzdienstleistungsaufsicht (BaFin)<br>Lurgiallee 12<br>60439 Frankfurt<br>or<br>Graurheindorfer Str. 108<br>53117 Bonn<br>Phone +49 (0) 228-4108-0<br>Fax +49 (0) 228- 4108-1550<br>Email:poststelle@bafin.de<br>www.bafin.de</p><hr><p>The European Commission has set up a European online dispute resolution platform ("ODR platform") at https://ec.europa.eu/consumers/odr/. 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