The holy grail: Saldanha (above) says Glenmark's goals are clear; it wants to be a pure innovation company. It hopes to get six compounds to launch stage by 2012

Balaglitazone, or DRF 2593, happens to be the most advanced NCE (new chemical entity, or molecule) in the country, having successfully completed phase II clinical trials. Dr Reddy's now hopes to announce shortly the launch of phase III trials for this molecule meant for the treatment of type 2 diabetes.

If it is balaglitazone or bala (as it is referred to internally) for Dr Reddy's, it is oglemilast (GRC 3886) for Mumbai-based Glenmark Pharmaceuticals. Currently in phase II trials, it will treat asthma and Glenmark hopes to launch it by 2009/2010. That is not all. By then, it hopes to get another lead to launch stage. This is GRC 8200, a novel drug for type II diabetes that it recently out-licensed to Merck kgaa.

There are other companies in pursuit of their own drugs. Pharma major Ranbaxy, has a molecule, RBX 11160 (an anti-malarial) in phase II clinical trials, Wockhardt has WCK 771 (a broad spectrum antibiotic) also in phase II. Zydus Cadila has four new molecular entities in development and this includes zyh1, a compound for treating dyslipidemia (read: high cholesterol), which is also undergoing phase II clinical evaluation. Similarly, Nicholas Piramal India has a lead molecule in oncology (P 276) that belongs to a novel class of anti-cancer agents called CDK 4 inhibitors. This is undergoing phase I/II clinical trials in Canada and India. The company also has two candidates in the inflammation space and one in infectious diseases. The one in infectious diseases is an anti-fungal herbal product in phase II clinical trials. In fact, various analysts say that about 10 companies could be pursuing any kind of serious NCE research and working in all with some 40 NCE leads.

Analysts, however, point out that arguably the most aggressive pursuers of NCEs are Dr Reddy's and Glenmark. The latter hopes to get up to six compounds to the launch stage over the next five years (by 2012). At the moment, these molecules are in various stages of development, with the most advanced being GRC 3886 (oglemilast)-an asthma and chronic obstructive pulmonary disease (COPD) molecule.

"Companies need to first define their goal and decide where they want to be," says Glenn Saldanha, CEO, Glenmark. "A few of our contemporaries have still not made that decision. We are clear that we need to be a pure innovation company and our generic business will only help fuel innovation,'' says Saldanha. The company has heavily focussed on this in the past five years and now on hopes to get one molecule every year into clinical trials.

As for Dr Reddy's, it has a pipeline of nine NCEs, of which five are in clinical development and four in pre-clinical stage. Out of its portfolio, the company has assigned four NCEs to Perlecan Pharma and one each is under a co-development arrangement with Rheoscience A/S of Denmark (this is for DRF 2593, or bala) and ClinTec International (this is for DRF 1042 in phase II, meant for solid tumors). Other than these, Dr Reddy's plans to complement the internal R&D efforts by pursuing, what it calls, "strategic partnerships and alliances". "It has taken us 10 long years to get to this stage. We licensed it (bala) out (to Novo Nordisk) in 1997 (Novo exited the deal subsequently),'' says K. Anji Reddy, Chairman, Dr Reddy's Labs.

In the last three years (fiscal 2004, 2005 and 2006), Dr Reddy's spent Rs 73 crore, Rs 87 crore, and Rs 82 crore, respectively, towards drug discovery activities. But what excites him, says Reddy, is that some of their drugs could well change the way people live-in particular, drugs relating to obesity and atherosclerosis (fat deposits along artery walls). "It is time more Indian companies realised that there is a window of opportunity-not many Big Pharma companies are coming out with blockbusters," he says. With some luck, companies like Dr Reddy's may soon earn the innovator tag.