Lupin inks strategic joint venture agreement with Yoshindo

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 authorizations 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 commercialization 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 $496m (IMS MAT March 2013).

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.

Lupin vice chairman Dr Kamal K Sharma noted that the company is very excited about the joint venture with Yoshindo, a partner who shares Lupin’s 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," Sharma added.