On November 13, 2023 mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, reported an exclusive licensing agreement with MS Pharma to commercialize the Denosumab biosimilar in select MEA markets (Press release, mAbxience, NOV 13, 2023, View Source [SID1234637549]). Denosumab is a monoclonal antibody drug that inhibits bone resorption. It is indicated for two major therapy categories: bone metastasis from various cancer forms and prevention of bone pain and fractures, including osteoporosis-related injuries.
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Under the agreement’s terms, mAbxience will conduct the full development of the biosimilar and manufacture it in its state-of-the-art, Good Manufacturing Practice (GMP) approved facilities, while MS Pharma will guide the products through regulatory approval and have exclusive commercialization rights in select MEA Countries. The financial terms of the transaction were not disclosed.
This partnership signifies a deeper collaboration between mAbxience and MS Pharma, building upon their previous licensing agreements with bevacizumab and rituximab and further advancing their shared mission to enhance global health. "We are excited to further solidify our relationship with MS Pharma through this new agreement. This collaboration will introduce a world-class biosimilar for bone diseases and oncology treatment to patients across the MEA region, underscoring our commitment to ensuring global access to high-quality, life-enhancing treatments. In tandem with MS Pharma, we are steadfast in our dedication to offering affordable and accessible healthcare solutions, positively impacting public health, and fortifying our position in the global biosimilar space," said Emmanuelle Lepine, CEO of mAbxience.
Kalle Känd, CEO at MS Pharma, said: "This agreement marks a significant milestone in MS Pharma’s journey to becoming a frontrunner in the specialized field of biosimilars. Our partnership with mAbxience underscores our mutual quest to enhance patient care by providing advanced therapeutic options that are effective, accessible, and affordable. By bringing the Denosumab biosimilar to MEA markets, we are addressing a critical healthcare void in both bone diseases and oncology treatment and delivering on our promise of better health for all."
The MEA region faces significant health challenges related to both cancer and bone diseases. Denosumab, a monoclonal antibody drug, is crucial in this context as it inhibits bone reabsorption and is indicated for bone metastasis from various cancer forms. Within the MEA region, the prevalence of low bone mass stands out as being notably higher than in western countries, emphasizing the urgent need for interventions and treatments. Alarmingly, despite abundant sunlight, the MEA region registers the highest global rates of rickets. The high prevalence of hypovitaminosis D, which could be a contributing factor to osteoporosis, is also a significant concern. Furthermore, post-hip fracture mortality rates are dauntingly high, being 2-3 times greater than those in western nations. These factors, combined with the rising incidence of cancer, underscore the essential need for comprehensive healthcare solutions, treatments, and interventions tailored to the region’s unique challenges.