Lupin and I'rom Enter Into An Exclusive Licensing Agreement For Denosumab Biosimilar For Japan

Global pharma major, Lupin Limited (Lupin) announced today that it has entered into an exclusive licensing agreement with I’rom Group Co. Ltd (I’rom), a leading pharmaceutical company in Japan. Under the terms of the Agreement, I’rom will conduct clinical trials along with Lupin, 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.

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. 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.

“We are pleased to partner with I’rom in Japan to bring this important biosimilar to the market. 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 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.”

About Lupin
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company 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.

The Company enjoys a leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. Lupin is the third-largest pharmaceutical company in the U.S. by prescriptions. The company invested 8.7% of its revenue in research and development in FY22.

Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.

About I’rom
Based on the Brand Promise of “For a future full of joy,” the I’rom Group has been working on technological development related to advanced medical care in order to consistently improve the quality of life of patients since its establishment and has been supporting clinical development of pharmaceutical products. While increasing the group value by combining the know-how and networks obtained in the process of promoting each business, we are promoting research and development of vaccines and gene therapy products using original vector technology, further the application of its advanced medical technology to cosmetics.

For more information, visit www.iromgroup.co.jp.