Holzkirchen, 25 January, 2016 – Sandoz, a Novartis company and the global leader in biosimilars, announced today that it has entered into an exclusive license agreement with Kyowa Hakko Kirin Co., Ltd for the distribution and promotion of its biosimilar rituximab - a monoclonal antibody, in Japan.
Under the terms of the agreement, Sandoz will file for marketing authorization of biosimilar rituximab and its manufacture if approved. Kyowa Hakko Kirin will be responsible for all sales, marketing and promotion activities in Japan.
Kyowa Hakko Kirin will pay Sandoz an up-front fee, subsequent payments for regulatory filing, regulatory approval, success-based milestones, royalties as well as defined supply price for every order.
“The agreement with Kyowa Hakko Kirin announced today demonstrates our commitment to expanding patient access to biosimilars across the world” said Carol Lynch, Global Head Biopharmaceutical & Oncology Injectables, Sandoz. “If approved, biosimilar rituximab means that healthcare professionals in Japan will have more choice in what they prescribe to their patients with hematological cancers.”
Sandoz is committed to increasing patient access to high-quality, life-enhancing biosimilars. It is the pioneer and global market leader and currently markets three biosimilars. Sandoz has a leading pipeline and plans to make 10 regulatory filings over a three year period (2015-2017). As part of the Novartis Group, Sandoz is well-positioned to lead the biosimilars industry based on its experience and capabilities in development, manufacturing and commercialization.
Disclaimer The foregoing release contains forward-looking statements that can be identified by words such as: “will”, “approved”, “plans”, “expects,” “potential,” or similar terms, or by express or implied discussions regarding potential marketing approvals for biosimilar rituximab, or regarding potential future revenues from biosimilar rituximab. 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 biosimilar rituximab will be approved for sale in Japan, or at any particular time. Neither can there be any guarantee that biosimilar rituximab will be submitted or approved for sale in any additional markets, or at any particular time. Nor can there be any guarantee that biosimilar rituximab will be commercially successful in the future. In particular, management’s expectations regarding biosimilar rituximab could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; competition in general, including potential approval of additional versions of biosimilar rituximab; global trends toward health care cost containment, including government, industry and general public pricing pressures; unexpected litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Sandoz from selling biosimilar rituximab; the particular prescribing preferences of physicians and patients; unexpected safety issues; unexpected manufacturing or quality issues; general economic and industry conditions, 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, a Novartis company, is a global leader in generic pharmaceuticals and biosimilars, driving sustainable access to high-quality healthcare. Sandoz employs more than 26,000 people worldwide and 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 2014 sales of USD 9.6 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.