Lupin signs agreement with I’rom for clinical trials and marketing of post-menopause drug in Japan

Global pharma major Lupin Limited has entered into an exclusive licensing agreement with Japanese company I’rom Group Co. Ltd (I’rom) for conducting clinical trials on biosimilar Denosumab in Japan. 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.

The company will also register, distribute and market the biosimilar as well on an exclusive basis. 

Following the completion of the clinical trial and receipt of marketing authorization from Pharmaceuticals and Medical Devices Agency (PMDA) an -independent administrative institution responsible for ensuring the safety, efficacy and quality of pharmaceuticals and medical devices in Japan, I’rom will exclusively commercialize the product in the country.

As part of the agreement, Lupin will receive multiple milestone payments. Currently, Denosumab is available under two brands, Pralia™ and Ranmark™, with a market size of approximately 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,” said Nilesh Gupta, Managing Director, Lupin.

“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 progress of 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,” he said.

ICICI securities in a recently released report said that Lupin’s Q1FY23 performance was disappointing on profitability front. It reported its worst-ever EBITDA margin of 6.2% due to restructuring in the US as well as continuous impact of inflation on raw materials and freight.  The company, however, is expecting a strong bounce back in the next quarter with new strategies in the business.

Lupin develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

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