Lupin inks licensing pact with Japan-based I’rom Group

Drug maker Lupin on Thursday said it has inked a licensing pact with Japan-based I’rom Group Co for a product used in the treatment of postmenopausal women with osteoporosis, among others.

Under the terms of the agreement, I’rom along with the Mumbai-based drugmaker will conduct clinical trials, register, distribute and market biosimilar Denosumab in Japan on an exclusive basis. Denosumab is indicated for the treatment of postmenopausal women with osteoporosis at high risk of fracture and prevention of skeletal-related events in patients with bone metastases from solid tumours, among other indications.

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Following the completion of the clinical trial and receipt of marketing authorisation in Japan, I’rom will commercialise the product in the island nation, Lupin said in a statement. As part of the agreement, the drug maker will receive multiple milestone payments, it added. Currently, Denosumab is available under two brands, Pralia and Ranmark, with market size of about USD 500 million in Japan.

“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,” Lupin Managing Director Nilesh Gupta noted. 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.

“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,” he added. Shares of Lupin were trading 1.2 per cent down at Rs 669.50 apiece on the BSE.