Four Canadian provinces add Erelzi™ (etanercept) to provincial drug plans for the treatment of multiple inflammatory diseases

• Erelzi has been added to drug formularies in Manitoba, Saskatchewan, Alberta and Newfoundland based on specific criteria for the treatment of moderate to severe rheumatoid arthritis and for reducing signs and symptoms of active ankylosing spondylitis.
• Erelzi also becomes the first biosimilar indicated for polyarticular juvenile idiopathic arthritis1 under each of these public drug plans.

BOUCHERVILLE, QC, April 19, 2018 /CNW Telbec/ - Manitoba, Saskatchewan, Alberta and Newfoundland are the most recent provinces to add Sandoz biosimilar Erelzi (etanercept) to provincial drug plans for the treatment of multiple inflammatory diseases.

The provincial listings respectively became effective on April 19 in Manitoba, April 1, 2018 in Saskatchewan, Newfoundland and on March 1, 2018 in Alberta. Sandoz biosimilar Erelzi was granted Health Canada approval in April 2017 and was launched in Canada in August 2017. Sandoz is a Novartis division and the global leader in biosimilar medicines. Public access to Erelzi is also available in British Columbia, New Brunswick, Ontario, Prince Edward Island, Yukon and Quebec.

"Erelzi adds to the options that patients and rheumatologists have to treat inflammatory arthritis such as rheumatoid arthritis, ankylosing spondylitis and juvenile arthritis," said Professor Walter Maksymowych, Chief Medical Officer, CaRE Canadian Research & Education in Arthritis.

Erelzi is reimbursed under specific criteria for the treatment of moderately to severely active rheumatoid arthritis (RA) in adults, and for reducing signs and symptoms of active ankylosing spondylitis (AS). In addition, Erelzi will be the only biosimilar to be reimbursed for the treatment of polyarticular juvenile idiopathic arthritis (JIA) in patients aged 4 to 17.1 JIA is a condition that affects approximately three out of 1,000 children and teenagers in Canada.2

"We are pleased that Manitoba, Saskatchewan, Newfoundland and Alberta recognize the important impact that access to Erelzi can have on reducing the burden of disease and delivering important savings to the healthcare system and the public drug plan," said Karine Matteau, Executive Director, Biopharmaceuticals, Sandoz Canada. "Erelzi is another concrete example of how Sandoz is making access happen by offering high-quality medicines at a more affordable price, which will deliver important savings to the healthcare system."

Erelzi is available in a pre-filled syringe (PFS) and in the SensoReady^® auto-injector (AI) pen, an ergonomic device for patients with limited dexterity. Erelzi is available in a 25 mg and 50 mg PFS, and is the only etanercept available in a 25 mg PFS.

A biosimilar is a biologic that is launched after the loss of patent exclusivity on the reference biologic. It's a highly similar biological medicinal product, having demonstrated therapeutic equivalence to a biologic reference product and hence comparable efficacy, safety, tolerability and immunogenicity profiles. Biosimilars can increase access to effective treatments for patients, as well as reduce the ongoing economic burden currently existing in the Canadian healthcare system that is impacting patients, physicians and payers. Recently, Canada's Patented Medicine Prices Review Board estimated that the potential cost savings from biosimilars could range from $332 million to $1.81 billion.3

Sandoz is committed to increasing patient access to high-quality, life-enhancing biosimilars. Sandoz markets five biosimilars in Europe and beyond, more than any other company. Sandoz, a division of Novartis, is well-positioned to lead the biosimilars industry based on its experience and capabilities in development, manufacturing and commercialization.

About Erelzi

Erelzi is the Sandoz biosimilar of the reference medicine Enbrel^®. Erelzi has been studied in a global development program, which included a comprehensive comparison of Erelzi and Enbrel^® at the analytical, preclinical, and clinical levels. The program included preclinical studies, pharmacokinetic (PK) studies, and the Phase III confirmatory safety and efficacy EGALITY study between Erelzi and Enbrel ^®.

Health Canada approval was based on a comprehensive development program consisting of comparative analytical, preclinical, and clinical data demonstrating biosimilarity to the reference medicine, Enbrel^®.

Studies included: analytical (extensive comparative physicochemical and functional assessment of Erelzi and the reference biologic drug), preclinical, Phase I pharmacokinetic (PK), and the Phase III confirmatory study EGALITY– an innovative safety and efficacy study in a sensitive indication to detect potential differences between Erelzi and Enbrel^®.

The totality of evidence demonstrates that Erelzi matches Enbrel^® in terms of structure, function, PK, efficacy, safety and immunogenicity. Based on this evidence, Health Canada granted market authorization to Erelzi indicated for: treatment of moderately to severely active rheumatoid arthritis (RA) in adults, reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients aged 4 to 17 years and reducing signs and symptoms of active ankylosing spondylitis (AS).4

Disclaimer

The foregoing release contains forward-looking statements that can be identified by words such as "potential," "can," "soon," "committed," or similar terms, or by express or implied discussions regarding potential additional marketing approvals or labeling for Erelzi, or any of the other potential products in the Sandoz biosimilar pipeline, or regarding potential future revenues from Erelzi, the other marketed products in the Sandoz biosimilar portfolio, and the potential products in the Sandoz biosimilar pipeline. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management 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 Erelzi or any of the other marketed products in the Sandoz biosimilar portfolio will be submitted or approved for sale in any additional markets, or at any particular time. Neither can there be any guarantee that any of the potential products in the Sandoz biosimilar pipeline will be submitted or approved for sale in any market, or at any particular time. Nor can there be any guarantee that Erelzi if approved, any of the potential products in the Sandoz biosimilar pipeline will be approved for any or all of the indications in the respective reference product's label. Nor can there be any guarantee that Erelzi, the other marketed products in the Sandoz biosimilar portfolio, or the potential products in the Sandoz biosimilar pipeline will be commercially successful in the future. In particular, management's expectations regarding Erelzi and such other biosimilar candidates and marketed products could be affected by, among other things, regulatory actions or delays or government regulation generally; the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; competition in general, including potential approval of additional versions of Erelzi; global trends toward health care cost containment, including government, payer and general public pricing and reimbursement pressures; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Sandoz from selling its biosimilar products; the particular prescribing preferences of physicians and patients; general economic and industry conditions; safety, quality or manufacturing issues, 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 International GmbH is a global leader in generic pharmaceuticals and biosimilars. As a division of the Novartis Group, our purpose is to discover new ways to improve and extend people's lives. We contribute to society's ability to support growing healthcare needs by pioneering novel approaches to help people around the world access high-quality medicine. Our portfolio of approximately 1000 molecules, covering all major therapeutic areas, accounted for 2017 sales of USD 10.1 billion. In 2017, our products reached well over 500 million patients and we aspire to reach one billion. Sandoz is headquartered in Holzkirchen, in Germany's Greater Munich area. For more information, visit www.sandoz.com.

Sandoz Canada is part of Sandoz International GmbH, a global leader in generic pharmaceuticals and biosimilars and a subsidiary of Swiss multinational Novartis AG. A leader in its field, Sandoz Canada develops, markets and distributes a broad line of generic, biosimilar, consumer and specialty products.

• ^TM: Erelzi is a trademark owned or used under license by Sandoz Canada Inc.
• ^®: Enbrel is a trademark owned by its registrant

For interview opportunities, please contact Paule Pelletier (see contact information below).

1- Sandoz Canada did not seek a marketing authorization for the treatment of psoriatic arthritis or plaque psoriasis.

2- The Arthritis Society: http://arthritis.ca/understand-arthritis/types-of-arthritis/childhood-arthritis: accessed on November 15, 2017.

3- Potential savings for Biosimilars in Canada : Government of Canada: http://www.pmprb-cepmb.gc.ca/view.asp?ccid=1304: accessed on November 15, 2017.

4- Sandoz Canada did not seek a marketing authorization for the treatment of psoriatic arthritis or plaque psoriasis.

For further information:

Paule Pelletier
Sandoz Canada Inc.
+1 450 641 4903 ext. 2109
+1 514 702-7699 (mobile)
[email protected]

Chris Lewis
Sandoz Global Communications
+49 8924 476 1906 (direct)
+49 174 244 9501 (mobile)
[email protected]