Lupin, Yoshindo form JV for clinical development of biosimilars in Japan
YL Biologics will also handle regulatory filings and obtain marketing authorizations for these drugs in Japan
Mumbai: Drug maker Lupin Ltd has entered a strategic joint venture (JV) agreement with Yoshindo Inc., a Japanese pharmaceuticals company, to form a new entity, YL Biologics (YLB) for conducting clinical development of certain biosimilars, Lupin said on Wednesday.
Biosimilar medicines are follow-on versions of original biological medicines, developed independently after the expiry of the patent protecting the original product.
The new company, to be jointly managed by the partners, will also handle regulatory filings and obtain marketing authorizations for these drugs in Japan.
Lupin said that its Etanercept biosimilar, developed by its biotechnology research group in Pune, will be the first product to be licensed for clinical development to the new joint venture. Etanercept is used to treat autoimmune diseases such as rheumatoid arthritis, psoriasis and ankylosing spondylitis.
The joint venture is part of Lupin’s strategy to make a bigger global push, including in fast-growing emerging markets such as Mexico, where it acquired Laboratorios Grin SA in March.
The company is also targeting lucrative niche segments such as inhalation, which is valued at over $23 billion in sales annually.
Lupin had recently acquired Nanomi BV in the Netherlands for the same reason and is in the process of setting up two dedicated research facilities in the US—one for inhalation and the other for complex injectables.
Lupin had earlier this week announced the appointment of Theresa Stevens as chief corporate development officer for its global operations. Stevens will assume full responsibility for global mergers and acquisitions and speciality business strategy.
The new joint venture entitles Lupin to milestone-based licensing income, in addition to commercial supplies of the drug substance. Both Lupin and Yoshindo will then market the product under their own brand names by leveraging their respective sales networks, Lupin said.
Lupin is currently one of the largest generic drug companies in Japan, having acquired Kyowa Pharmaceutical Industry Co. Ltd in 2005 and following it up by acquiring a couple of small businesses in that market.
The Japanese biologicals market is currently valued at $12 billion and is growing at 2-3%. Of this, biosimilars, or the generic versions, are valued at $3.5 billion, growing at 5%.
The new joint venture between Lupin and Yoshindo will involve in-licensing—a sharing agreement—monoclonal antibodies from Lupin and also partnering other companies across the globe for the Japanese market. Yoshindo will bring its expertise and capabilities in formulations, device development and in coordinating clinical studies and regulatory filings in Japan.
Shares of Lupin gained 0.52% to Rs.987.25 on BSE on Wednesday, while Sensex rose 0.52% to 22,876.54 points.
Lupin has a basket of 10 biosimilar drug candidates in various stages of development, covering areas such as cancer, inflammation, antivirals, osteoporosis and rheumatoid arthritis.
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