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Wednesday, May 1, 2019

Sandoz in commercialization pact on breast cancer biosimilar candidate

Sandoz, a Novartis division and a global leader in biosimilars, today announced that it has entered into an agreement to commercialize a proposed trastuzumab biosimilar.
This medicine is currently in Phase III clinical development for treatment of human epidermal growth factor receptor 2 positive (HER2+) breast and specific gastric cancer tumors.
The agreement between Sandoz and EirGenix, Inc, a biotechnology manufacturing and development company that aspires to provide high-quality medicines for individuals and society, aims to bring to market a proposed biosimilar trastuzumab. EirGenix will maintain responsibility for development and manufacturing, and Sandoz has the right to commercialize the medicine upon approval in all markets excluding China and Taiwan.
According to the terms of the agreement, EirGenix will receive an upfront payment on signing, milestone payments, and is entitled to receive profit share payments for sales in the territories. This structure allows Sandoz to keep in-house resources focused on bringing forward a robust internal pipeline. The collaboration further expands the existing Sandoz oncology portfolio of four oncology biosimilar medicines, while enabling the company to further develop its strong hospital presence. Other specific terms of the agreement are confidential.
‘Every year, approximately 300,000 people worldwide are diagnosed with HER2-positive breast cancer, which tends to spread more quickly than HER2-negative tumors, making swift treatment important. While targeted therapy is available, high out-of-pocket costs lead to limited treatment in the US and reimbursement issues have resulted in varying uptake in Europe’,[1],[2] said Stefan Hendriks, Global Head of Biopharmaceuticals, Sandoz. ‘Introducing biosimilars can help create earlier and expanded access to this important medicine, which is why I am so excited about the potential for this collaboration.’

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