Lupin has announced a licensing agreement with Japan-based I’rom Group Co for a product used in the treatment of postmenopausal women with osteoporosis, among other things.
According to the terms of the agreement, I’rom will conduct clinical trials, register, distribute, and market biosimilar Denosumab in Japan on an exclusive basis with the Mumbai-based drugmaker.
Denosumab is approved for the treatment of postmenopausal women with osteoporosis who are at high risk of fracture, as well as the prevention of skeletal-related events in patients with solid tumor bone metastases.
I’rom will commercialize the product in Japan following the completion of the clinical trial and receipt of marketing authorization, Lupin said in a statement.
The drugmaker will receive multiple milestone payments as part of the agreement, it added.
Denosumab is currently available in Japan under two brands, Pralia and Ranmark, with a market value of approximately USD 500 million.
Nilesh Gupta, Managing Director, Lupin, said, “Biosimilars are a key growth driver for Lupin, and through products such as this, we are making significant progress in improving access and affordability of important treatments for patients.”
Elaborating further, Lupin President Biotechnology Cyrus Karkaria said in post-menopausal women, osteoporosis is often caused by estrogen decline and is a common condition associated with advancing age.
He further added, “It can result in severe clinical consequences, such as back pain and bone fractures, particularly in the spine and hips. In progressing our development program for denosumab biosimilar, we hope to provide patients with early and expanded access to advanced biologic medicines, which have the potential to change their course of illness.”
Discussion about this post