Sandoz announces agreement to acquire CIMERLI® business from Coherus, strengthening position in US market

AGÊNCIA DE COMUNICAÇÃO Conteúdo de responsabilidade da empresa 22 de janeiro de 2024

Sandoz Group

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

MEDIA RELEASE

• CIMERLI^®*, a ranibizumab biosimilar, is interchangeable with LUCENTIS^®** (ranibizumab-injection) for all approved indications
• Acquisition strengthens Sandoz ophthalmology portfolio

Basel, January 22, 2024 Sandoz, the global leader in generic and biosimilar medicines, has signed an agreement to acquire the US biosimilar ranibizumab CIMERLI^®* (ranibizumab-eqrn) from Coherus BioSciences, Inc. for an upfront cash purchase payment of USD 170 million. This is inclusive of a biologics license application, product inventory, ophthalmology sales and field reimbursement talent, as well as access to proprietary commercial software.

Keren Haruvi, President Sandoz North America, said: I am pleased that we can add another high-value product to the growing Sandoz biosimilar portfolio, further strengthening our existing ophthalmology franchise. The addition of CIMERLI^® reinforces our commitment to biosimilars and represents a huge step towards our goal of pioneering patient access to more affordable and much-needed medicines in the US.

Sandoz looks forward to providing even more treatment options for US patients with vision impairment and loss. The agreement to acquire the CIMERLI^®* business from Coherus allows us to build a more robust ophthalmic platform that would support future product launches.

Closing is anticipated in 1H 2024, subject to standard conditions and approvals.

About CIMERLI^®

CIMERLI^®* solution for injection 0.3 mg (6 mg/mL) and 0.5 mg (10 mg/mL) is an FDA-approved biosimilar to reference product LUCENTIS^®** (ranibizumab injection) that is indicated for the treatment of multiple retinal diseases including wet age-related macular degeneration (wAMD), diabetic macular edema (DME), macular edema following retinal vein occlusion (RVO), myopic choroidal neovascularization (mCNV) and diabetic retinopathy (DR).1 CIMERLI^®* is an anti-VEGF therapy within a class of biologics that helps retinal patients maintain or gain vision2. CIMERLI^®* was approved by the FDA in August 2022, having met FDAs rigorous standards of biosimilarity to the reference product, including safety, efficacy, and quality. Launched in October 2022, it is the first and only FDA-approved biosimilar interchangeable with LUCENTIS^®** for all indications.

IMPORTANT SAFETY INFORMATION & INDICATIONS

CIMERLI®* (ranibizumab-eqrn) is interchangeable*** to LUCENTIS®** (ranibizumab injection)

CIMERLI®* (ranibizumab-eqrn), a vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of patients with:

• Neovascular (Wet) Age-Related Macular Degeneration (AMD)
• Macular Edema Following Retinal Vein Occlusion (RVO)
• Diabetic Macular Edema (DME)
• Diabetic Retinopathy (DR)
• Myopic Choroidal Neovascularization (mCNV)

CONTRAINDICATIONS

• Ocular or periocular infections
• Hypersensitivity

WARNINGS AND PRECAUTIONS

• Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be monitored following the injection.
• Increases in intraocular pressure (IOP) have been noted both pre- and post-intravitreal injection.
• There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors.
• Fatal events occurred more frequently in patients with DME and DR at baseline, who were treated monthly with ranibizumab compared with control.

ADVERSE REACTIONS

The most common adverse reactions (reported more frequently in ranibizumab-treated subjects than control subjects) are conjunctival hemorrhage, eye pain, vitreous floaters, and increased IOP.

For additional Safety Information, please see CIMERLI^® Full Prescribing Information available here.

To report SUSPECTED ADVERSE REACTIONS, contact Coherus BioSciences at 1-800-483-3692 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

*CIMERLI^® is a registered trademark of Coherus BioSciences, Inc.

**LUCENTIS^® is a registered trademark of Genentech USA, Inc.

***An interchangeable product (IP) is a biological product that is approved based on data demonstrating that it is highly similar to an FDA-approved reference product (RP) and that there are no clinically meaningful differences between the products; it can be expected to produce the same clinical result as the RP in any given patient; and if administered more than once to a patient, the risk in terms of safety or diminished efficacy from alternating or switching between use of the RP and IP is not greater than that from the RP without such alternation or switch. Interchangeability of CIMERLI^®* has been demonstrated for the condition(s) of use, strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information

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 managements 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 update or revise any forward-looking statements, except as required by law.

References

1.        CIMERLI^®. Prescribing Information. Available at Prescribing Information.

2.        American Academy of Ophthalmology. Anti-VEGF Treatments. July 26, 2023. Accessed January 19, 2024. Anti-VEGF Treatments – American Academy of Ophthalmology (aao.org).

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. 22,000 people of more than 100 nationalities work together to bring Sandoz medicines to some 500 million patients worldwide, generating substantial global healthcare savings and an even larger total social impact. Its leading portfolio of more than 1,500 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to the year 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the worlds first oral penicillin in 1951, and the first biosimilar in 2006. In 2022, Sandoz achieved sales of USD 9.1 billion and core EBITDA of USD 1.9 billion.

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Attachment

• Sandoz Media Release Cimerli

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