- MS Pharma will guide the product through regulatory approval and have exclusive commercialization rights in select MEA
- mAbxience will undertake the development of the Denosumab biosimilar and manufacture and supply the commercial product for MS Pharma.
Madrid, Amman, November 13th, 2023 — mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, has announced today an exclusive licensing agreement with MS Pharma to commercialize the Denosumab biosimilar in select MEA markets. 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.
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[1],[2].
About MS Pharma:
MS Pharma is a leading regional pharmaceutical company operating in the MEA region, well-positioned for fast business growth, with its headquarters in Amman, Jordan, and management offices in Zug, Switzerland.
Established in 1989, MS Pharma has a robust presence in over 20 countries, and a diverse portfolio encompassing a wide array of generic, value-added, and biosimilar medicines, covering over 300 international nonproprietary names (INNs) for various treatments and maintaining more than 2000 market authorizations. MS Pharma’s operations are supported by three research and development centers and four manufacturing sites and boasts significant B2C capabilities with expansive reach in the Middle East and Africa.
For further details, please visit our website: www.mspharma.com.
About mAbxience:
mAbxience is a global Spanish-based company specializing in the development, production, and commercialization of biopharmaceuticals, supporting access to high-quality medicines. In August 2022, Fresenius Kabi and Insud Pharma entered into an agreement whereby Fresenius Kabi acquired a majority stake of mAbxience. With over a decade of expertise, our mission is clear: to provide accessible, affordable medicines across the globe, aiming to enhance the quality of life by ensuring universal access to high-caliber medicines. With two market-approved products and a robust pipeline in development, we have established a B2B presence in over 100 markets. Alongside this, we have formed a network with more than 30 partners and built a dedicated team of over 1,000 professionals. Our three multi-product facilities, located in Europe and South America, have obtained GMP approval from esteemed regulatory bodies, including the FDA, EMA, and others. Furthermore, as a global biopharmaceutical expert, mAbxience specializes in Contract Development and Manufacturing Organization services (CDMO), utilizing advanced technology and innovative platforms to deliver integrated manufacturing solutions. For more insights into mAbxience, our biosimilars and CDMO business, please visit our website (www.mabxience.com) or connect with us on LinkedIn.
[1] International Osteoporosis Foundation. Key statistics for the Middle East and Africa: https://www.osteoporosis.foundation/facts-statistics/key-statistic-for-middle-east-and-africa
[2] BMC Musculoskeletal Disorders. The burden of musculoskeletal disorders in the Middle East and North Africa (MENA) region: a longitudinal analysis from the global burden of disease dataset 1990—2019: https://bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-023-06556-x
