STORY OF BALAGLITAZONE - INDIA’S FIRST NCE

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Submitted by abhi271183 on Wed, 03/19/2008 - 13:45.
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Dr. Reddy’s Laboratories Ltd. was founded in 1984 by Dr. K. Anji Reddy, has become India’s leading pharmaceutical company.
Dr. Reddy’s lab started R&D program for anti-Diabetic molecule in 1994. Company started working on three anti-diabetic molecules;

Balaglitazone was the first lead molecule in anti-diabetic segment comes out from the company research lab and early trials showed sensitization effect on the cells to Insulin. Balaglitazone is a second generation PPAR-Gamma agonist with partial agonistic properties( Partial agonistic activity is supposed to be responsible for reducing side effects)

Dr.Reddy’s Lab. out licensed Balaglitazone to Danish Pharma major Nova Nordisk in 1997 to subside risk as well as cost involved in it. But immediately after out licensing Balaglitazone, Dr.Reddy’s lab came up with another superior lead molecule in the same category i.e. Ragaglitazone, which was looking more promising than Balaglitazone as having similar action to Balaglitazone in addition to lipid reducing capacity.

Ragaglitazone was also out licensed to Nova Nordisk in 1998, when it was in II phase of clinical trials. As the Ragaglitazone was superior, Nova Nordisk decided to start working on molecule and suspended clinical development of Balaglitazone in the
middle, as other companies also attacked Balaglitazone drug class.

Just when carrier of Balaglitazone appeared to have ended, Ragaglitazone shocked Nova Nordisk just at the end of Phase III of clinical trials, as tumors were discovered in rats during long tern carcinogenicity studies. Nova Nordisk suspended Ragaglitazone program, and again started working on Balaglitazone, but once again Nova Nordisk suspended Balaglitazone program due to unconvincing results and returned the molecule to Dr. Reddy Lab. in 2004.

Beside of financial constraints Dr.Reddy’s Lab. started working on Balaglitazone along with Rheosciences, also a Danish company in 2004. At present Balaglitazone is in Phase III of clinical trials, undergoing carcinogenicity long term studies.

Balaglitazone is expected to hit the market by 2011. Dr.Reddy’s Lab preserved marketing rights except for China and Europe, It includes rest of the world including the US and India.

Abhishek Gupta
e-mail - abhi271183@gmail.com