Drug major Lupin has entered into a joint venture agreement with Japanese pharma company Yoshindo Inc to create new entity YL Biologics (YLB). This joint venture will focus on biosimilar development and commercialisation for Japan. CNBC-TV18's Archana Shukla spoke to KK Sharma, VC, Lupin to get the details of the JV.
Below are excerpts from the interview:
Q: Will it in-licence products from Lupin's biosimilar pipeline or is the JV open to sourcing from other companies as well?
A: It can have both. Predominantly, it will be Lupin products but the joint venture will be open to consider other products from other originators as well.
Q: Which products would be from Lupin's portfolio?
A: At the moment, we are starting with one product that is Enbrel and there would be couple of more products but it will be a little premature to talk about those products because there is a pipeline which we don't want to discuss at the moment. However, this is a very laudable experiment because taking a biosimilar to advance market is for the first time, out of India.
Although, I also know that Lupin was relatively much late into the game because we started only in 2007 and the game has been in the country since 1992. In that sense, it is a very proud moment for the company to have built the technology.
We have about eight proteins in our pipeline today of which five are monoclonal antibody bodies. Post 2016, there is a floodgate of these products opening up and I have often spoken about the new specialty character that we are trying to bring into Lupin which starts with technology intensity, capital intensity, regulatory intensity and so forth. So, this is one of the manifestations of that specialty character.
Q: What kind of investments would we look from Lupin as well as your joint venture partner into this? How could the marketing pan out once the products are into the market? What is the timeline that you are seeing for these products to hit the market?
A: I can only talk a bit of general things here. The clinical development cost could be anywhere in the range of USD 35-50 million. We would share that equally. The joint venture is going to in-licence the product from Lupin. Though I cannot share with you but there will be upfront payment and there will be kind of milestone payments for that.
Once the development is done the clinical data would be submitted to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. We have already had interviews with the regulators and we have arrived at a particular protocol for clinical work.
Japan has the best track record in the world for approving products and therefore, we hope that in two-and-a-half years to a maximum of three years we should see this product getting a marketing authorisation from the regulators. The deal is that we would share the file between Yoshindo and Lupin.
If we want to bring in another partner, that will be joint venture addition, not addition of anyone of us. However, it would be best if we both own the files and market ourselves. We would be marketing different brands of the same product.
Lupin stock price
On April 23, 2014, Lupin closed at Rs 987.25, up Rs 5.10, or 0.52 percent. The 52-week high of the share was Rs 1012.00 and the 52-week low was Rs 679.35.
The company's trailing 12-month (TTM) EPS was at Rs 42.06 per share as per the quarter ended December 2013. The stock's price-to-earnings (P/E) ratio was 23.47. The latest book value of the company is Rs 108.10 per share. At current value, the price-to-book value of the company is 9.13.
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