Indigene Pharmaceuticals Inc, a US based company founded by an NRI in which Tata Industries has recently picked up a stake of over 26 percent, is on the verge of completing of Phase-III clinical trials of IG-RD-001, a natural molecular combination for multiple symptoms of allergy rhinitis.

According to Dr. M Vaman Rao, chairman and CEO of the company who is on a visit to India, compliance of regulatory requirements of registration would be first completed in the EU, India and the CIS countries as it takes less time in these countries and marketed in the US later. In the US alone the market size for rhinitis is US $ seven billion (over Rs.32000 crores).

Indigene is working on other drugs for metabolic and respiratory disorders, oncology and other diseases, and most of them are in pre-clinical stage. In non prescription or healthcare segment, Indigene has four products that are ready for launch and another three products are close to the launch in the US. After the US, Indigene would be launching these products in India and other countries. All these products have been successfully tested for efficacy and safety according to US regulations, he said.

Dr.Rao also said that his organization had adopted a new platform of multiceuticals which are molecular combinations that take multiple pathways, treat multiple symptoms and give multiple benefits. Dr. R A Mashelkar, director general of the Council of Scientific and Industrial Research (CSIR) and secretary, Department of Scientific and Industrial Research (DSIR), recently said that traditional Pharma industry is facing challenges like spiraling drug prices, shrinking new product pipelines and unmet medical needs and to address these challenges new age Pharma approach of Indigene is required.

Dr.Rao said that IG-RD-001 could quickly come to completion of Phase-III clinical trials because of the choice of the new research platforms of multiceuticals. He said since the 1990s, despite all the advancements in R&D tools including IT, globally the success rate in drug discovery has been less than in the pre-1990s. Further, the time taken for discovery to clinical trials has also increased leading to higher costs. Keeping this limitation of contemporary approach of single new molecule, better known as New Chemical Entities (NCEs) in view, Indigene has taken the molecular combination approach, Dr. Rao said, “We started as a small company, but we have started the company with the objective to be a global company from day one. Our choice of approach is a clear evidence of that”, Dr. Rao said, and added that the road map for that is innovation, development, brand building and being global. He said that in line with this objective, the company is actively seeking partnerships mainly in product development and marketing, and licensing products.

Founded in 2002, Indigene took to reverse pharmacology method and designed a proprietary MMV technology platform to create optimal combinations of molecules that work simultaneously on multiple symptoms or disease fronts. This strategy was based on new findings that diseases/symptoms involve a network of multiple pathways and targeting a single pathway using a single NCE may not deliver an efficient therapeutic solution. For developing leads in selected disease areas, Indigene has also established an alliance with CSIR.