8 new Drug molecules from India

Two decades after Indian Pharma started dabbling in new drug research, eight indigenously developed novel drugs are gearing up for late-stage human trials.While two new molecules are being developed by BioCon and Glenmark each, the others are contributed by Dr.Reddy’s, Sun, Ranbaxy and Primal life sciences.

Dr Reddy’s anti-diabetic drug, codenamed DRF 2593-307, was the first indigenously developed novel drug to enter phase-III trials, in August 2007. This is the penultimate round of testing on patients before marketing approval can be sought. Last year, two more compounds made it to this stage: Biocon’s oral insulin pill and Ranbaxy’s anti-malaria drug. A fourth drug, from Glenmark, to treat diarrhoea, is concurrently undergoing phase-II and phase-III trials.

1) IN-105 (Biocon)

• Therapy area: Diabetes-insulin
• Status: In phase-III human trials
• Target launch: 2011 in India; rest of the world by 2015
• Global market size: $13 billion
• Global players: Novo Nordisk, Eli Lilly

2) T1h (Biocon)

• Therapy area: Psoriasis & rheumatoid arthritis
• Status: Completed phase-II trials
• Target launch: Not yet announced
• Global market size: $15-16 billion
• Global players: Astellas, BMS, Abbot, Amgen

3) DRF 2593-307IN (Dr Reddy’s Lab)

• Therapy area: Diabetes-PPAR agonists
• Status: In phase-III trials
• Target launch: Not announced yet
• Global market size: $7 billion
• Global players: Glaxo, Takeda, Abbot, Solvay

4) Crofelemer (Glenmark Pharma)

• Therapy area: Diarrhoea
• Status: In phase-III trials
• Target launch: 2010-11
• Global market size: $2-3 billion
• Global players: Glaxo

5) Sun-1334H (Sun Pharma)

• Therapy area: Allergy
• Status: Completed phase-II trials
• Target launch: Not Announced Yet
• Global market size: $5.5 billion
• Global players: Sanofi-Aventis, Pfizer

6) GRC 8200 (Glenmark Pharma)

• Therapy Area: Diabetes-DPP IV inhibitor
• Status: Completed phase-II trials
• Target launch: 2013-14
• Global market size: $1-2 billion
• Global players: Merck

7) P276 (Primal Life sciences)

• Therapy area: Cancer
• Status: Late phase-II trials
• Target launch: To file for marketing approval in 2011
• Global market size: $47.7 billion
• Global players: Roche, Eli Lilly, Pfizer, Glaxo

8) Arterolane Maleate+Piperaquine Phosphate (Ranbaxy)

• Therapy area: Malaria
• Status: Currently in phase-III trials
• Target launch: To apply for marketing approval by late-2010
• Global market size: Less than $1 billion
• Global players: Novartis

Source- Outlook Business 

In spite of lower costs of operating in India, R&D of new drug molecules is a long, tiring and expensive affair. The Indian companies have invested in drug molecules especially required in India ( like drugs for malaria, Diabetes, Diarrhoea). The fate of these 8 molecules may well decide future R&D plans of Indian Pharma companies. 

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• Drug Discovery and Indian Pharma Industry