Sandoz acquires rights to PF-06438179 (biosimilar infliximab) in the European Economic Area (EEA)*
Sandoz plans to complete Phase III development program and file for registration in the EU
Deal strengthens Novartis immunology portfolio which includes investigational biosimilars adalimumab, etanercept and rituximab
Holzkirchen, 12 February, 2016 – Sandoz, a Novartis company and a global leader in biosimilars, announced today that it has acquired from Pfizer the rights for the development and commercialization of PF-06438179 (biosimilar infliximab) in the 28 countries that form the European Economic Area (EEA)*. Infliximab is a tumor necrosis factor alpha (TNF-α) inhibitor used to treat a range of autoimmune diseases including rheumatoid arthritis (RA) and psoriasis.
“Infliximab is one of the most important biologic therapy options for people living with severe autoimmune diseases such as rheumatoid arthritis” said Richard Francis, Division Head and CEO Sandoz. “We intend to complete the development and registration of PF-06438179 and make it available to patients across Europe as part of our robust portfolio of immunology treatments” Francis continued.
Under the terms of the deal, Sandoz plans to complete the clinical study program and submit the biosimilar infliximab to the European Medicines Agency (EMA) for regulatory approval and registration with the European Commission. Included in the program is a global phase III trial - REFLECTIONS (B537-02) investigating the safety and efficacy of PF-06438179 and infliximab in combination with methotrexate in subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate. Sandoz acquired the rights to infliximab, following Pfizer’s commitments to the European Commission in connection with the acquisition of Hospira, Inc. to divest the program.
Sandoz is committed to increasing patient access to high-quality biosimilars. It is the pioneer and global market leader in biosimilars and was the first to launch biosimilars in the United States, Europe and Japan. Sandoz has a leading biosimilar pipeline with programs in various stages of development and regulatory filing including biosimilars adalimumab and etanercept that, like infliximab, are anti-tumor necrosis factor α (TNF-α) medicines. The company plans to make 10 regulatory filings over a three year period (2015-2017) having already announced five, which include biosimilar etanercept filed with both the EMA and the US Food and Drug Administration. As part of the Novartis Group, Sandoz is well-positioned to lead the biosimilars industry based on its deep experience and capabilities in development, manufacturing and commercialization.
* Pfizer retains commercialization and manufacturing rights to infliximab in all countries outside of the EEA.
The foregoing release contains forward-looking statements that can be identified by words such as "plans," "investigational," "will," "commitment," "pipeline," "well-positioned to lead," or similar terms, or by express or implied discussions regarding potential marketing approvals for PF-06438179, or regarding potential future revenues from PF-06438179. 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 PF-06438179 will be submitted or approved for sale in any market, or at any particular time. Nor can there be any guarantee that PF-06438179 will be commercially successful in the future. In particular, management's expectations regarding PF-06438179 could be affected by, among other things, the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; competition in general, including potential approval of additional versions of biosimilar infliximab; unexpected litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Sandoz from selling biosimilar infliximab; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures; unexpected safety issues; unexpected manufacturing or quality 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.
Sandoz, a Novartis company, is a global leader in generic pharmaceuticals and biosimilars, driving sustainable access to high-quality healthcare. Sandoz supplies a broad range of affordable, primarily off-patent products to patients and customers around the globe. The Sandoz portfolio comprises approximately 1,100 molecules, which accounted for 2015 sales of USD 9.2 billion. Sandoz is headquartered in Holzkirchen, in Germany’s Greater Munich area. The company holds leading global positions in biosimilars as well as in generic anti-infectives, ophthalmics and transplantation medicines.