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Lupin and I’rom inks agreement for Denosumab biosimilar for Japan

Denosumab is indicated for the treatment of postmenopausal women with osteoporosis.

August 25, 2022 3:15 IST | India Infoline News Service
Global pharma major, Lupin Limited has announced on Thursday that it has entered into an exclusive licensing agreement with leading pharmaceutical company in Japan 'I’rom Group Co. Ltd (I’rom), a leading pharmaceutical company in Japan. 
According to the agreement, along with Lupin, I’rom will conduct clinical trials and also 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 tumors among other indications.
After following the completion of the clinical trial and receipt of marketing authorization from PMDA in Japan, I’rom will exclusively commercialize the product in Japan market. Further, Lupin will receive multiple milestone payments, as per the signed agreement. Currently, Denosumab is available under two brands, Pralia and Ranmark, with a market size of approximately USD 500 million in Japan.
“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,” said Dr. Cyrus Karkaria, President – Biotechnology, Lupin. 
“In progressing our development program for denosumab biosimilar, we hope to provide patients with early and expanded access to advanced biologic medicines, which has the potential to change their course of illness.”

At around 3:15 PM, Lupin Ltd is currently trading at Rs668.45 per share down by Rs9.2 or 1.36% from its previous closing of Rs677.65 per share on the BSE.

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