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Biopharmaceuticals Product Launch

 News Release - February 28, 2017

Kevzara(TM) (sarilumab) now available in Canada for the Treatment of Adult Patients with Moderately to Severely Active Rheumatoid Arthritis

Comprehensive patient support program also announced

MISSISSAUGA, ON, Feb. 28, 2017 (Healthcare Sales & Marketing Network) - Sanofi Genzyme, the specialty business unit of sanofi-aventis Canada Inc., is pleased to announced the Canadian availability of KevzaraTM (sarilumab), an interleukin-6 (IL-6) receptor antibody, for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more biologic or non-biologic Disease-Modifying Anti-Rheumatic Drugs (DMARDs).1

"With Kevzara, we have a promising new therapy in Canada, which has shown clinically-meaningful and statistically significant improvements in adult patients with moderately to severely active rheumatoid arthritis," said Dr. William Bensen, Clinical Professor of Rheumatology, Department of Medicine at McMaster University, Ontario, Canada. "Kevzara represents a welcome new treatment option that works differently from the most commonly used biologics."

Developed by Sanofi and Regeneron, Kevzara is a fully human monoclonal antibody that binds specifically to both soluble and membrane-bound IL-6 receptors, and has been shown to inhibit IL-6-mediated signalling through these receptors.1 Local production of IL-6 by synovial and endothelial cells in joints affected in chronic inflammatory disease, such as RA, may play an important role in development of the inflammatory processes.1

"We are proud to bring this important innovation to Canada where a need remains for those whose symptoms have progressed despite trying other treatments for their moderate to severe RA," said Peter Brenders, General Manager, Sanofi Genzyme for Canada.

RA is a systemic inflammatory disease that can affect multiple joints in the body. In RA, inflammation manifests in the lining of the joints causing pain, swelling, joint damage and can lead to deformity. RA impacts 70 million adults worldwide.2,3 In Canada alone, RA affects approximately 300,000 people. RA is most common in people between 40 and 60 years old; however, it can occur in adults at any age.4

The recent Health Canada approval of Kevzara was based on data from approximately 2,900 adults with moderately to severely active RA who had an inadequate response to previous treatment regimens, including seven studies from the global SARIL-RA clinical program. Kevzara demonstrated clinically-meaningful improvements, either as monotherapy or in combination with conventional DMARDs, including methotrexate, in reducing signs and symptoms, improving physical function, and inhibiting radiographic progression of structural damage of RA in approximately 1,743 patients with moderately to severely active RA.5,6,7,8,9,10 Kevzara should be used in combination with methotrexate or other traditional DMARDs, or may be given as monotherapy in cases of intolerance or contraindication to methotrexate or DMARDs.1 The recommended dose of Kevzara is 200 mg once every two weeks given as a subcutaneous injection; dosage can be reduced from 200 mg to 150 mg once every two weeks to help manage certain laboratory abnormalities.1

Patients treated with Kevzara are at increased risk for developing serious infections that may lead to hospitalization or death.1 The most frequent adverse reactions (occurring in at least 3% of patients treated with Kevzara in combination with DMARDs) observed with Kevzara in the clinical studies were neutropenia (6-10%), increased alanine aminotransferase (4-5%), injection site erythema (3-4%), and upper respiratory tract infections (3%).1

Sanofi Genzyme is committed to helping patients who are prescribed KEVZARA gain access to the medicine and receive the support they may need. It will offer a patient support programme called Mobilize which will provide injection training and follow up service calls, as well as home delivery and reimbursement assistance service. For more information, please call 1-888-972-6634 or email info@mobilizera.ca .

About Sanofi

Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Sanofi Consumer Healthcare. Sanofi is listed in Paris (EURONEXT:SAN) and in New York (SNY).

In Canada, we employ close to 1,900 people. In 2015 Sanofi companies invested $133.3 million in R&D in Canada, creating jobs, business and opportunity throughout the country.

Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families. Learn more at www.sanofigenzyme.ca.

About Regeneron Pharmaceuticals, Inc.

Regeneron (REGN) is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL cholesterol and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, atopic dermatitis, asthma, pain, cancer and infectious diseases. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.

1 Kevzara (sarilumab) Product Monograph Health Canada. January 2017.

2 Gibofsky, A. Overview of Epidemiology, Pathophysiology, and Diagnosis of Rheumatoid Arthritis. Am J Manag Care. 2012 Dec;18(13 Suppl):S295-302.

3 United Nations, Department of Economic and Social Affairs, Population Division (2015). World Population Prospects: The 2015 Revision, Key Findings and Advance Tables. Working Paper No. ESA/P/WP.241.

4 The Arthritis Society. Rheumatoid Arthritis. Available at: https://arthritis.ca/understand-arthritis/types-of-arthritis/rheumatoid-arthritis. Last Accessed January 2017.

5 Genovese, MC. Sarilumab Plus Methotrexate in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate: Results of a Phase III Study. Arthritis Rheumatology. 2015 Jun 67(6):1424-37..

6 Fleischmann, R. Sarilumab and Non-Biologic Disease-Modifying Antirheumatic Drugs in Patients With Active RA and Inadequate Response or Intolerance to TNF Inhibitors. Arthritis Rheumatology. 2016 Nov 10.1002/art.39944..

7 Sanofi. To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis (SARIL-RA-EASY). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 28 May 2015]. Available from: https://clinicaltrials.gov/ct2/show/NCT02057250 NLM Identifier: NCT02057250.

8 Emery P, Rondon J, Garg A, et al. Safety and tolerability of subcutaneous sarilumab compared to intravenous tocilizumab in patients with RA. Arthritis Rheumatol. 2015;67(suppl 10): 971..

9 Burmester G, Garg A, van Hoogstraten H, et al. Sarilumab dose reduction to manage laboratory abnormalities in an open-label extension study in RA patients. Arthritis Rheumatol. 2015;67 (suppl 10): 2762..

10 Sanofi. To Evaluate the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Rheumatoid Arthritis (RA) (SARIL-RA-ONE). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 28 May 2015].


Source: Sanofi Genzyme

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