On May 28, 2024 Bio-Thera Solutions (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, and global specialty, generic and consumer healthcare medicines company STADA Arzneimittel AG reported to have have reached an exclusive commercialization and license agreement for BAT2506, a biosimilar candidate to Simponi (golimumab) (Press release, BioThera Solutions, MAY 28, 2024, View Source [SID1234643750]).
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Under the agreement, Bio-Thera Solutions ("Bio-Thera") will maintain responsibility for development, manufacturing, and supply of BAT2506. STADA Arzneimittel AG ("STADA") will have exclusive rights to commercialize the product in the European Union (EU), the UK, Switzerland and selected other countries.
Bio-Thera will receive an upfront payment of US$10 million, as well as further development and commercial milestones of up to US$147.5 million, subject to the fulfillment of certain conditions.
"STADA is one of the premier biosimilar companies in Europe, and we are pleased to establish a partnership with STADA for BAT2506", said Dr. Shengfeng Li, CEO of Bio-Thera. "We look forward to working with STADA to bring BAT2506 to immunology patients in Europe."
"With global sales in 2023 of US$2.2 billion, including more than US$1 billion outside of the US, golimumab represents a compelling opportunity to broaden patient access to biological treatments and build scale in immunology alongside our approved adalimumab and ustekinumab biosimilars. Bio-Thera’s broad expertise in biologic medicines, including with two biosimilars already approved by the US Food and Drug Administration, makes it an attractive partner for STADA," commented STADA’s head of Global Specialty, Bryan Kim.
Golimumab is a human IgG1 monoclonal antibody that targets tumor necrosis factor alpha (TNF- α), a pro-inflammatory molecule. Binding of golimumab to TNF-α results in reductions in C-reactive protein (CRP), Interleukin 6 (IL-6), Intercellular Adhesion Molecule 1 (ICAM-1), Matrix Metalloproteinase 3 (MMP-3), and Vascular Endothelial Growth Factor (VEGF), all inflammatory markers.