Sandoz AG expands reach of Hyrimoz® (adalimumab-adaz) in US through commercialization agreement with Cordavis

• Sandoz AG and Cordavis announce agreement to commercialize Hyrimoz® (adalimumab-adaz) in US under Cordavis private label
• Cordavis will release and commercialize private-labeled Hyrimoz in US starting in Q1 2024
• Agreement supports Sandoz in its mission to pioneer access to important medicines and enhance access to biosimilars in the US

Basel, August 23, 2023 — Sandoz, a global leader in generic and biosimilar medicines, today announced a multi-year agreement with Cordavis, a wholly owned subsidiary launched by CVS Health^®, to bring Hyrimoz^® (adalimumab-adaz) to patients in the US.

Richard Saynor, Sandoz CEO, said: “This agreement is the result of a shared commitment to lower healthcare costs and ensure patients can access the medicines they need. It has the potential to extend the reach of our adalimumab biosimilar, Hyrimoz, and help Sandoz realize our goal of overcoming the hurdles that hinder access to more affordable biologic treatments.”

Under the terms of the agreement, Sandoz Hyrimoz, private-labeled for Cordavis, will be  released and commercialized by Cordavis in the US beginning in the first quarter of 2024. Sandoz will also provide patient-support services, including copay assistance, to Cordavis through a commercial agreement. Sandoz will continue to commercialize Sandoz-labeled Hyrimoz and contract with pharmacy benefit managers (PBMs) and payers directly in the US for this product.

Cordavis works directly with manufacturers to bring biosimilar products to the US pharmaceutical market. Through Cordavis, CVS Health intends to develop a portfolio of products that it expects will facilitate broader access to biosimilars in the US.

Sandoz is dedicated to helping millions of patients sustainably and affordably access critical and potentially life-changing biologic medicines across a range of therapeutic areas, including immunology, oncology, supportive care and endocrinology. Since launching the first biosimilar in the US in 2015, Sandoz has demonstrated that biosimilars expand patient access to life-altering medicines while increasing healthcare savings. Increased competition generated by market entry of Sandoz biosimilars also continues to fuel innovation, supporting the development of new and enhanced treatments in areas of unmet need. 

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,” “may,” “could,” “would,” “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, data integrity 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 Hyrimoz® (adalimumab-adaz)
Adalimumab, the active ingredient in Hyrimoz, is an inhibitor of tumor necrosis factor (TNF), a protein that is overproduced in certain autoimmune conditions — including rheumatoid arthritis, plaque psoriasis, Crohn's disease and ulcerative colitis — causing inflammation and tissue destruction in joints, mucosa or skin. In some cases of autoimmune disease, the immune system damages the body’s own tissues. Hyrimoz targets and blocks the protein that contributes to disease symptoms.1

INDICATIONS

HYRIMOZ® (adalimumab-adaz) is a tumor necrosis factor (TNF)-blocker indicated for Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. HYRIMOZ can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older. HYRIMOZ can be used alone or in combination with methotrexate. Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA. HYRIMOZ can be used alone or in combination with non-biologic DMARDs. Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS. Crohn’s Disease (CD): treatment of moderately to severely active CD in adults and pediatric patients 6 years of age and older. Ulcerative Colitis (UC): treatment of moderately to severely active UC in adult patients. Limitations of Use: Effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF-blockers. Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic Ps who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HYRIMOZ should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician. Hidradenitis Suppurativa (HS): treatment of moderate to severe HS in adult patients.

SELECT IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS: None.

WARNINGS AND PRECAUTIONS: Serious infections: Do not start HYRIMOZ during an active infection. If an infection develops, monitor carefully, and stop HYRIMOZ if infection becomes serious. Invasive fungal infections: For patients who develop a systemic illness on HYRIMOZ, consider empiric antifungal therapy for those who reside or travel to regions where mycoses are endemic. Malignancies: Incidence of malignancies was greater in adalimumab-treated patients than in controls. Anaphylaxis or serious hypersensitivity reactions may occur. Hepatitis B virus reactivation: Monitor HBV carriers during and several months after therapy. If reactivation occurs, stop HYRIMOZ and begin anti-viral therapy. Demyelinating disease: Exacerbation or new onset, may occur. Cytopenias, pancytopenia: Advise patients to seek immediate medical attention if symptoms develop, and consider stopping HYRIMOZ. Heart failure: Worsening or new onset, may occur. Lupus-like syndrome: Stop HYRIMOZ if syndrome develops.

ADVERSE REACTIONS: Most common adverse reactions (>10%) are: infections (e.g. upper respiratory, sinusitis), injection site reactions, headache and rash.

DRUG INTERACTIONS: Abatacept: Increased risk of serious infection. Anakinra: Increased risk of serious infection. Live vaccines: Avoid use with HYRIMOZ.

This is not the complete list of all the safety information for HYRIMOZ. Please click to see the full Prescribing Information for HYRIMOZ, including Boxed Warnings and Medication Guide.

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 vision is to be the world’s leading and most valued generics company. Our broad portfolio of high-quality medicines covers major therapeutic areas.

Sandoz on social media:
LinkedIn: https://www.linkedin.com/company/sandoz
Twitter: https://twitter.com/sandoz_global
Facebook: https://www.facebook.com/sandozglobal/
Instagram: https://www.instagram.com/sandozglobal 

CEO Richard Saynor on LinkedIn: https://www.linkedin.com/in/richard-saynor/

References
1.    Hyrimoz. Prescribing Information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761071s015lbl…