Dr Reddys Unit, Denmark Firm Sign Research Pact

Dr Reddys Research Foundation (DRRF), the R&D outfit of Dr Reddys Laboratories (DRL) has finalised an agreement with Novonordisk of Denmark for further development of a compound of gliotazone, an anti-diabetes drug. The agreement is likely to be initialled by the end of this month. DRRF has already filed papers for patenting four derivatives of the drug world-wide.

Gliotazone compounds are considered to be a major breakthrough in the treatment of diabetes as their action is radically different from the available anti-diabetes drugs, the main characteristic being that they do not induce hypoglycaemia.

Under the agreement, the European company will take up clinical trials, packaging and marketing globally for the drug while DRL will be the sole manufacturer of the drug globally. It will also co-market the drug in India.

 

Once the agreement is initialled, DRL will get a substantial upfront payment and milestone payments for the three phases of clinical trials lasting 54 months after which it will get royalty on sales throughout the world.

While the details of the payments are not being disclosed, it has been stated that the tie-up will help DRRF to be on its own, once funds start flowing from Denmark. At present, DRRF is funded by the two majors in the DRL Group, DRL and Cheminor Drugs.

Sources in DRL describe the agreement as a pathbreaking one since it is the first Indian company to obtain product patent for a drug. Earlier, only process patents were being obtained.

Clinical trials are time consuming and costly ,involving investment between US$100 -200 million which no Indian company can afford. For this reason, DRL has sought the tie up with the European major.

Novonordisk is a $2.5 billion company, with a 56 per cent global market share in insulin and presence in 120 countries. Teams from Novonordisk have been regularly visiting DRRF and were appreciative of the facilities available for R&D. DRRF has so far invested Rs 20 crore in equipment and by the end of March this year another Rs 20 crore would be expended as revenue expenditure.

DRRF has also filed documents for an anti-cancer compound, particularly effective in colon cancer and has tied up with Debiopharm of Switzerland for clinical trials and for obtaining registration. Troglitazone, the first in the family of glitazone compounds, was discovered by Sankyo of Japan and co-developed with Warner Lambert of the US. It has recently obtained clearance from the Food and Drug Administration of the US and put the drug in the market a few weeks ago.

Earlier, Takeda Chemical of Japan had discovered a derivative of the gliotazone family and tied up with Upjohn for further development. But it has not so far been marketed. ADIR of France, in collaboration with the Beechamn Group of UK, Yamanuchi and Mitsubishi, both of Japan are the others in line to market a derivative of glitazone. Sources in DRRF maintain that the glitazone compound they have discovered is far superior to those now being developed including Sankyos troglitazone.

According to pre-clinical trial reports, the DRRF product is far more potent than the other derivatives of the glitazone family. A lower dosage of the drug is required and its efficacy is also more. Cost of treatment is also less. The Sankyo-discovered compound is estimated to cost $2 per day towards treatment.

In fact, the discovery of the glitazone compounds themselves may be considered a major breakthrough in the treatment of diabetes.

Insulin was discovered 76 years ago in 1921. And sulphonylureas replaced insulin in certain areas 35 years ago. There are six FDA approved sulphonylureas derivatives in the market currently.

According to medical professionals, the superiority of glitazone derivatives over insulin and sulphonylureas lies in the fact that the new drug does not induce production of more insulin, but uses insulin already being produced.