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Sandoz begins Phase III clinical trial for biosimilar adalimumab

December 18, 2013
Sandoz, the global leader in biosimilars, announced it has initiated a Phase III clinical trial with its biosimilar version of adalimumab (AbbVie’s HUMIRA®) – the leading treatment of several autoimmune conditions including rheumatoid arthritis, psoriasis, and Crohn’s disease. This is Sandoz’s eighth Phase III trial initiation across six compounds.

  • Sandoz advances leading biosimilars pipeline by strengthening Immunology portfolio
  • Global program marks Sandoz’ sixth biosimilar molecule to enter Phase III testing
  • Trial will support registration in the U.S. and European Union

The aim of the study is to demonstrate equivalent efficacy, similarity, and immunogenicity of the Sandoz product versus HUMIRA® in patients with moderate to severe plaque-type psoriasis. Sandoz is working closely with physicians and patients on this global trial, which spans 12 countries across Europe, the United States and Asia including Japan.

Psoriasis affects approximately 3% of the world's population1. There is significant unmet need in psoriasis with between nine and 30 percent of patients with severe psoriasis receiving no treatment at all2. “Because psoriasis is a chronic condition that often requires lifelong management, treatment can become a significant financial strain for many patients and healthcare systems,” said Professor Dr. Peter van de Kerkhof, Chairman of the Department of Dermatology at the Radboud University Nijmegen Medical Centre in The Netherlands and President of the International Psoriasis Council (IPC) Board of Directors. “A high-quality and clinically proven biosimilar version of adalimumab could play a meaningful role in alleviating cost burdens related to this disease.”

“This latest advancement in our pipeline represents our unwavering commitment to expanding patient access to biologics – particularly in disease areas where there is a significant need for more treatment choices,” said Mark McCamish, M.D., Ph.D., and Head of Global Biopharmaceutical & Oncology Injectables Development at Sandoz. “We look forward to bringing a high-quality and affordable biosimilar version of adalimumab to individuals around the world living with psoriasis and other debilitating autoimmune diseases such as rheumatoid arthritis.”

“Adalimumab will be a key building block in our growing Immunology portfolio, which includes other biosimilar candidates currently in Phase III trials such as etanercept (Amgen’s Enbrel®) and rituximab (Roche's Rituxan®/MabThera®),” said Ameet Mallik, Sandoz’ Head of Biopharmaceuticals and Oncology Injectables. “This key development milestone further strengthens our global leadership in biosimilars and builds on our industry-leading pipeline.”

Sandoz is the pioneer in biosimilars and the global market leader with over 50 percent market segment share of all biosimilars approved in the highly regulated markets of U.S., Canada, Europe, Japan and Australia. All three Sandoz biosimilars occupy the #1 biosimilar position (volume market share) in their respective categories. Sandoz biosimilars are sold in over 50 countries and have generated over 100 million patient exposure days in experience.

Disclaimer
This press release contains forward-looking statements that can be identified by terminology such as “begins,” “will,” “aim,” “can,” “could,” “commitment,” “look forward to,” “growing,” or similar expressions, or by express or implied discussions regarding potential new biosimilar products; or regarding potential future sales of biosimilar products. Such forward-looking statements reflect the current views of the Novartis Group regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that any new biosimilar products will be submitted or approved for sale in any market. Nor can there be any guarantee that Sandoz will achieve any particular financial results from its biosimilar products. In particular, management's expectations could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally, including the potential outcome of the FDA’s biosimilars regulatory process; unexpected clinical trial results, including additional analyses of existing clinical data or unexpected new clinical data; unexpected product manufacturing issues; government, industry, and general public pricing pressures; competition in general; unexpected development difficulties; unexpected patent litigation outcomes; the impact that the foregoing factors could have on the values attributed to the Group's assets and liabilities as recorded in the Group's consolidated balance sheet; and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. 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 as a result of new information, future events or otherwise.

About Sandoz

Sandoz, the generic pharmaceuticals division of Novartis, is a global leader in the rapidly growing generics industry. Sandoz employs over 26,000 employees in more than 140 countries, offering broad range of over 1,000 high-quality, affordable products that are no longer protected by patents. With USD 8.7 billion in sales in 2012, Sandoz holds the #1 position globally in biosimilars as well as generic injectables, ophthalmics, dermatology and antibiotics as well as strong positions in the treatments for central nervous system disorders, gastrointestinal medicines, cardiovascular treatments, and hormone therapies. Sandoz develops, produces, and markets these medicines along with pharmaceutical and biotechnological active substances. In addition to strong organic growth since consolidating its generics businesses under the Sandoz brand name in 2003 , Sandoz has benefitted from strong growth of its acquisitions including Lek (Slovenia), Sabex (Canada), Hexal (Germany), Eon Labs (US), EBEWE Pharma (Austria), Oriel Therapeutics (US), and Fougera Pharmaceuticals (US).

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For further information, contact:

Sreejit Mohan
Head of Communications
Biopharmaceuticals & Oncology Injectables
Sandoz
+49 (0) 80244762550
sreejit.mohan@sandoz.com

Footnotes:
HUMIRA® is a registered trademark of AbbVie
ENBREL® is a registered trademark of Amgen
Rituxan®/MabThera® are registered trademarks of Roche

References:
[1] International Federation of Psoriasis Associations (IFPA) World Psoriasis Day website. "About Psoriasis."
Accessed August 2013.
[2] Armstrong AW et al. JAMA Dermatol 2013 Aug 14.

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