Osteologix, Inc. through its wholly owned Irish subsidiary Osteologix Limited and the Servier Research Group, the leading French independent pharmaceutical company, announced that Osteologix has granted Servier an exclusive royalty bearing license to develop and commercialize NB S101 (strontium malonate) to treat post menopausal osteoporosis, other bone and joint disorders and dental indications worldwide, except in the US NB S101 is an innovative molecule acting on both bone formation and bone resorption.
Under the terms of the agreement, Osteologix will receive up to €12 million in upfront and milestone payments.
Additionally, Osteologix is eligible to receive up to €30 million in minimum royalty payments creditable against mid to low single digit royalties on sales. Osteologix will also be eligible to receive milestone payments and royalties on product development and sales in Japan. The agreement is subject to customary termination provisions.
Servier will be responsible for all costs outside of the US associated with development, regulatory approval and commercialization of NB S101. Osteologix will continue to own intellectual property rights for development in the US.
Philip J. Young, Osteologix' president and chief executive officer commented, "I am very happy that we have been able to reach agreement on this important collaboration. This endorsement from one of the top Pharmaceutical Companies worldwide is appropriate recognition for NB S101 and its value in treating osteoporosis.
Servier is consistently recognized as a benchmark for excellence in the pharmaceutical industry, having received multiple industry accolades for its attention to patients’ and doctors’ needs, and successful clinical development of “first in class” innovations. We fully expect this history of excellence to continue, as they prepare for the commercial launch of NB S101"
Emmanuel Canet, M.D., Ph.D., Head of Servier Research and Development, stated “We are very pleased with this collaboration which will allow us to further develop our franchise in osteoporosis and other bone & joint diseases that affect millions of patients worldwide with much suffering and disability. Osteoporosis in particular is a serious public health problem that requires effective and well tolerated treatments in order to significantly decrease the risk of vertebral and hip fractures.”
The World Health Organization defines osteoporosis as a progressive skeletal disease characterized by low bone mass and micro-architectural deterioration of bone tissue with a consequential increase in bone fragility and susceptibility to fracture. There is increased risk of fracture particularly of spine, hip, pelvis and forearm. It is predominantly a disease of post-menopausal women and risk of fracture increases with age. Fractures caused by osteoporosis affect one in two women and one in five men over the age of 50.
NB S101 is a novel dual acting bone agent, or DABA, the active component of which significantly improves bone mineral density and reduces fracture risk. NB S101 has demonstrated significant beneficial effects in a phase 2 clinical trial by reducing bone resorption and increasing strong bone formation. This dual action on bone– a significant medical need not served by current therapies in the US– suggests that NB S101 could fundamentally change the treatment paradigm of patients with osteoporosis. Importantly, NB S101 appears to help build bone in a manner similar to the body’s own metabolic processes by rebalancing bone metabolism in a way that favors strong bone formation. Key patents for NB S101 have been issued in the United States, Europe and Japan, providing protection to at least 2024.
Servier is the leading independent pharmaceutical company in France and the second in the world. . The Servier Research Group is established in 140 countries with its main therapeutic products used to treat diabetes, cardiovascular disease, CNS disorders, oncology and rheumatology.
Osteologix is a specialty pharmaceutical company committed to developing innovative therapies for the treatment and prevention of diseases of bone and joint tissues.