Lupin in pact with Japan’s Yoshindo to set up joint venture `YL Biologics’

Pharma Major Lupin Limited (Lupin) has entered into a strategic joint venture agreement with Japanese pharmaceutical company, Yoshindo Inc, to create a new entity called Y L Biologics (YLB).

YLB will be jointly managed by both partners who will also be responsible for conducting clinical development of certain biosimilars, including regulatory filings and obtaining marketing authorisations in Japan.

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  clear cut 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). 

The Japanese market for biological is currently valued at close to $12 billion and growing at 2-3 per cent annually. mAbs make up $3.5 billion of the overall Japanese biological sales and growing at 5 per cent as per IMS Health. 

Lupin will be entitled 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. 

''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,''  Dr Kamal K Sharma, vice chairman of Lupin Limited, said commenting on the joint venture.

''YL Biologics Ltd is our bridgehead to expand Yoshindo's activities to the biosimilar market in Japan and highlight on the strategic representation of 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,'' added Kenzo Shimomura, president of Yoshindo Inc.

Toyama, Japan-based Yoshindo Inc has a long history of trade in medicine. The company supplies a large and diverse range of pharmaceutical products such as generic formulations, APIs, infusion and dialysis under R&D, manufacturing and marketing system.

Yoshindo is now focusing on biopharmaceutical products and developing it in cooperation with institutions and corporates.