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Basic research on new drug compounds initiated by Indian companies over the last decade has progressed like a roller-coaster — a mix of hits and failures — but now reached a high degree of maturity.

In the nineties, Glenmark, Piramal, Dr Reddy’s Labs, Wockhardt, Cadila, Ranbaxy, Lupin and Biocon had all embarked into the highly unpredictable domain of fundamental discovery in new drugs with a broad range of therapies to work on.
Sun Pharma, too, considered much conservative in its business approaches had a determined jump in the business of finding innovative leads.

The years were marked by fears of failures like that of Vioxx, the Merck & Co drug, and data kept bombarding that the numbers of new drug approvals had fallen dramatically over the years.

Yet, companies much smaller than their western counterparts invested small amounts to get their research initiatives to a standard where foreign companies can look at them for partnerships — a huge advance from downright disdain.

From working on the newest antibiotic drugs to lifestyle ailments and even in the crowded area of monoclonal antibodies for cancer treatments or for auto-immune diseases, Indian companies boasted of a pipeline of promising compounds, though most of them were still in the labs.

Now many years later, companies have pipelines that are much smaller, and few among them are through with the safety and efficacy data; the expectations are more grounded and most importantly, having learnt tough lessons of over-hyping and absolute dejection, they are very cautious about trumpeting what they have.

Among the biggest setbacks was for Dr Reddy’s Laborataries, which saw two drugs dropped by Novo Nordisk — one a PPAR compound that showed deadly effects in mice and the other — also a PPAR molecule — had to be taken back as the Danish firm felt that the drug’s profile was not considerably different than the marketed compounds.

In the aftermath, Dr Reddy’s had to realign its research programmes and scale down its pipeline to just a few in the clinics.

Yet Dr Reddy’s in partnership with Rheoscience took the balaglitazone compound into efficacy studies and recently published the results that were seen by some scientists as encouraging.

Though the study was done on a few hundred patients — considering that diabetes drugs require large-scale studies — hopes are brightening for a potential best-in-class diabetes drug.

Admitted that this product — if it does scale the hurdles — will be a late entrant in the controversial glitazones class — but the thrill of seeing the first Indian drug in the international arena cannot be understated.

Another big disappointment was oglemilast, Glenmark’s asthma/COPD compound — a PDE 4 inhibitor — that was licensed to Forest Labs a few years back for an unprecedented hefty payment agreement.

After a prolonged period of uncertainty, Forest came out to say last November that it will discontinue its clinical research on the drug for COPD indication but awaits findings for the drug’s results in asthma patients. Unpleasant it may sound, but too much expectations were built around that single compound.

Also, an early debacle of the Eli Lilly partnership for work in pain management drugs bruised the company outlook to a large extent.
Now that investors are cautious about the valuations that they ascribe to experimental drugs, it’s good to carry on developmental studies minus the unreasonable expectations.

Glenmark, like a far-sighted player in the game, is going ahead and enriching its pipeline unfazed from the battering that it got from the stock market last year.

It has a follow-on compound called Revamilast in the proof-of-concept stage in addition to a drug under development for diarrhea and a biologic.

Piramal too has a very strong line-up. It has a cancer drug making satisfactory progress and is in the phase II studies.

It also has a very interesting anti-diabetes range but being a PPAR compound, reviews are seen to be risky.

Biocon is another company that claims to have done a great deal of work in oral insulin compound IN 105. The product was taken from Nobex of US and is now undergoing phase III studies in India.

Biocon has filed for clinical tests in US but the idea of popping an insulin tablet is difficult to digest, literally. Biocon is looking for an ideal partnership for the right scale up but it may need tones of studies to prove that point.

There are several remarkable products being worked upon in India. Not just by large companies, but smaller scientist-driven ones are also drawing attention, fuelled by private equity capital.
In drug discovery time is of essence and working quietly matters.

Though much is not being expected from any particular company, what is laudable is that they are all moving in the right direction, decisively.

Pillman is an executive closely linked to the global pharma industry