Lupin - Long-haul rider

In 2001, Lupin flagged off the Lupin Research Park in Pune, a centralised research centre. Spread over 19 acres, this R&D hub has some 400 scientists working on three focus areas: Innovative generics, novel drug delivery systems (NDDS), and new chemical entities (NCEs).

It’s a well-hedged strategy, with NDDS and generic R&D mitigating the high risk that comes along with NCE work (a little over Rs 200 crore has been spent on non-NCE work since 2001).

Also, in the NCE space, Lupin has also taken a safer route by opting for clinical trials in India.

Chairman: Desh Bandhu Gupta NCES in the pipeline: Four in clinical trials in India, one in pre-clinical development, two in early pre-clinical stage Therapeutic areas of focus: Migraine, psoriasis, tuberculosis, diabetes, obesity, arthritis Progress made: Two psoriasis compounds (one botanical) in Phase II; a botanical product for migrane (as a nasal spray) in Phase III; Phase I on an oral TB product completed. Investments so far in NCE research: Roughly 100 crore since 2001 (excluding capital expenses) Annual investment in R&D: 6-7 per cent of sales Likely target date for new drug launch: 2012-13 CEO-speak: “The cost of doing research in India has gone up from a 10th of that in the US a decade ago to a seventh today”

However, it has to take that big step, of getting US FDA approval (by starting with an investigational drug, or IND, application).

For three compounds, Lupin has made significant progress in clinical trials in India, and it hopes that because of these it can get certain waivers from the US FDA when it goes there.

For instance, Nilesh Gupta, President (Advanced Markets), Lupin, hopes that one of his psoriasis compounds may not have to do Phase I trials, or will be allowed to do a quick Phase II, and move straightway into the Phase III clinic in the US.

What may work in Lupin’s favour is the areas it has chosen to focus on. In psoriasis, for instance, the therapies in the market are 30-40 years old; and they are injectibles (Lupin’s two compounds are oral and nasal).

Also, in TB, there’s been no new oral drug on the market for three decades now. And they’re big markets. Migraine is worth $2 billion globally, and psoriasis $6 billion.

TB is relatively small at $850 million, but India could well prove to be the biggest market for Lupin’s drug, if it does hit the market.

For the time being, though, Chairman Desh Bandhu Gupta is content focussing on the low-investment but relatively high-return area of NDDs.

But he’s hopeful of launching a psoriasis drug in the global market in five years.

 — Brian Carvalho