Lupin, which will file its first biosimilar Etanercept in Europe and Japan in FY18, has tied up with a financial company to fund the research and development of the drug.
The drug-maker did not respond to an email on the issue and has not disclosed the financial company.
“We have not changed any of our focus on the R&D front. We are actively pursuing the complex generic pipeline,” Chief Executive Officer Vinita Gupta told analysts last month. “What we have done for some of the risky projects (is) we have opted to get a financing partner. We felt given the market evolution and the clinical risk, it would make sense to share some of the risk. So we have brought in some external financing in biologics.”
Etanercept is the first product for which Lupin has secured financing partner. Biosimilars are copies of innovative biologic drugs and are made from living cells. Lupin is partnering with another firm for drug development because of the high cost and risks in the process. Etanercept is used for treatment of rheumatoid arthritis and is a copy of Amgen’s innovative drug Enbrel.
At an investor conference in Mumbai last week, Lupin’s Managing Director Nilesh Gupta said the company was on track to file Etanercept in Europe and Japan in the current fiscal year and was developing a pipeline of select biosimilar drugs. Gupta said the firm was actively partnering for a few products and was targeting a market size of $19 billion.
In 2014, Lupin tied up with drug-maker Yoshido to help in clinical trials and commercialisation of biosimilars in the Japanese market. But the company has been slow to hit the market and peers, including Biocon and Intas, already sell their biosimilar drugs in Europe and Japan. Lupin has now stepped up its efforts to develop complex and specialty products.
In FY17, the drug-maker spent around Rs 2,300 crore on research and development expenses, which accounted for 13.5 per cent of its revenue. The company earned more than Rs 17,000 crore in revenue last fiscal year and around half of it came from the US.
An industry expert said Lupin’s move to secure external funding for the biosimilar drug made sense. These drugs are complex and expensive to manufacture, with development cost estimated to be around $50 million for each. Earlier this year, Cipla had decided to outsource manufacturing of biosimilars to reduce investment risk and improve its capital allocation.
Companies have in the past roped in investors to fund drug discovery.
Sun Pharma had listed its research arm, Sun Pharma Advanced Research Company, listed on the BSE in 2007. In 2005, Dr Reddy’s Laboratories (DRL) teamed up with ICICI Venture and Citigroup Venture Capital to create a drug development company called Perlecan Pharma.
DRL had transferred development and commercialisation rights of four new chemical entities to Perlecan Pharma. But that venture was short-lived. In 2008, DRL took over full ownership of the company.
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