Mumbai-based pharma major Lupin Limited has entered into a strategic joint venture agreement with Toyama-based pharmaceuticals company, Yoshindo Inc. (Yoshindo) to create a new entity, YL Biologics (YLB).
YLB will be jointly managed by both partners and will be responsible for conducting clinical development of certain biosimilars including regulatory filings and obtaining marketing authorisations in Japan. Financial terms of the JV are not disclosed.
With this venture Lupin will be entitled to milestone based licensing income in addition to commercial supplies of the drug substance. Both Lupin and Yoshindo will market the product under their own brand names by leveraging their respective sales networks.
Kamal K Sharma, vice chairman, Lupin, said, “We are very excited about the joint venture with Yoshindo, a partner who shares our commitment to bringing biosimilars to market in Japan. YLB is a reflection of Lupin’s long-term commitment to the Japanese market and is an important first step forward to establishing Lupin’s global biosimilar portfolio.”
The new entity YLB will in-license Monoclonal Antibodies (MAbs) from Lupin and also partner with other companies across the globe for the Japanese market, which already has a regulatory regime in place for the development and commercialisation of biologicals.
Lupin’s Etanercept biosimilar, developed by its Biotechnology Research Group in Pune, will be the first product to be licensed for clinical development to YLB. Etanercept (Originator Trade name: Enbrel) is a biopharmaceutical product approved globally for treating autoimmune diseases such as rheumatoid arthritis, psoriasis and ankylosing spondylitis.
Enbrel is marketed in Japan by Takeda Pharmaceutical and had sales of $496 million (IMS MAT, March, 2013).
Commenting on the JV, Kenzo Shimomura, president, Yoshindo Inc., said, “YL Biologics Ltd. is our bridgehead to expand Yoshindo’s activities to the biosimilar market in Japan and highlight the strategic representation of the company. We are very pleased to enter into a strong partnership with Lupin which will make it possible to jointly develop a meaningful biosimilar product pipeline for the Japanese market.”
The Japanese biological market is currently valued at close to $12 billion and growing at 23 per cent annually. MAbs make up $3.5 billion of the overall Japanese biological sales and growing at 5 per cent (IMS Health).
Yoshindo is supplying a large and diverse range of pharmaceutical products such as generic formulations, APIs, infusion and dialysis under R&D, manufacturing and marketing system. It is now focusing on biopharmaceutical products.
Lupin is producing and developing a wide range of branded and generic formulations and APIs globally. The company is a significant player in the cardiovascular, diabetology, asthma, paediatric, CNS, GI, anti-infective and NSAID space and holds global leadership positions in the anti-TB and cephalosporin segment.
For the financial year ended March 31, 2013, Lupin's consolidated turnover and net profit were Rs 9,461.6 crore ($1.74 billion) and Rs 1,314.2 crore ($242 million), respectively.
Recently the firm acquired Mexico-based ophthalmic products firm Laboratorios Grin, S.A. De C.V. (Grin) and Dutch complex injectables firm Nanomi B.V. for an undisclosed amount. With this acquisition, Lupin has made its foray into the technology intensive complex injectables space.
Early this week, the firm roped in Theresa Stevens as chief corporate development officer from Aptalis for its global operations. Theresa will be responsible for global merger and acquisitions (M&A) and speciality business strategy.
(Edited by Joby Puthuparampil Johnson)