The pharma industry is leaning heavily on hope. Recently, whenever there’s some positive news from regulators like the US FDA, the Indian pharma space has experienced a quickening of the pulse, and an adrenaline rush. As if sensing that the next big step will be easier to take, quicker to complete.

The most recent example: Avandia getting a clean chit from the US FDA.
The effect of this achievement materialised in a matter of hours. The US FDA ruling has given companies with a pipeline of molecules based on the glitazone class of compounds, more than one reason to feel that their future drugs will be met with a smile and a nod.

With the advent of the ruling, India’s Dr Reddy’s Labs has announced that it will be taking its own compound Balaglitazone into Phase-III human trials.

The drug (DRF 2593) was returned to Dr Reddy’s a few years ago by a well known MNC on grounds that the drug did not fit wholesomely into the latter’s pipeline. Dr Reddy’s doggedly pursued the product into future trials and then joined hands with a little known Danish company — Rheoscience — for human trials. The comparison drug for the human trials is Actos (Pioglitazone); it has the distinction of being seen as the best in its class, as far as its insulin-sensitizing capabilities are concerned.

Though multi-centric trials are frought with risks of failure, India may soon get its first ever drug invention! Provided, of course, DRF 2593 does succeed in its last stage of experiments.

The ray of hope stemming from Avandia’s success is blinding. And DRF 2593’s success could well be the stepping stone sought by companies which have been struggling with their research costs. What with WHO estimates suggesting that by 2030, the number of diabetics will double to 360 million, more such compounds from Indian companies will soon change their financial status. Not to mention better and cheaper drugs for the diabetic population.

The top deck of British drug giant GlaxoSmithKline must be breathing easy after the US FDA allowed Avandia, the $3 billion diabetes blockbuster to continue in the market.

Unlike Merck, Pfizer and Sanofi Aventis, GSK Pharma has been lucky. It’s escaped the wrath of the US FDA. Avandia came into the limelight when, in May this year, the New England Journal of Medicine published a study showing that the drug led to increased heart risks.

Like every drug in the past, the entire class of glitazone compounds came under the lens. This included Takeda’s Actos (Pioglitazone). Now, with the US FDA giving both drugs a clean chit, researchers hope that investigations in Phase-IV human trials (post-marketing surveillance) are being condusted in a more balanced manner.

The US FDA nod has also given birth to the feeling, within the industry, that though drugmakers struggle to launch new products, there is enough data generated to record the safety features of the drug.

All the biggies — from Lilly to Novartis to Pfizer to Glaxo — have seen unprecedented patent challenges in the last few years. This despite a dry spell as far as their research pipeline goes. The rejection of Avandia would have further complicated Glaxo’s future. So for now, Glaxo’s safe. But it’s a precarious situation. All it takes is another Vioxx or Celecoxib to snap the hair holding Damocles’ sword.