Avesthagen has received clearance from the Review Committee for Genetic Manipulation (RCGM) to carry out clinical trials of Darbepoetin alfa (AVDESP). Now the company has to approach the Drugs Control General of India (DCGI) to conduct the human studies. The company has indigenously developed several biosimilars in its R&D Lab at Bangalore. Four of these molecules are ready for trials before being licensed for selling in India.
Biosimilars reduce the cost of treatment of diseases drastically as they are often cheaper to produce. AVDESP will potentially reduce the financial burden as well as frequency of injections taken by the patients by 40-50 per cent. This biosimilar is to be used in the treatment of specific types of anaemia, like anaemia associated with chemotherapy/dialysis, where treatments are long drawn out.
For development of Darbepoetin-alfa-biosimilar, the company worked on a cell line to efficiently produce the protein molecule. This entire development was done in house in a short period of 18 months. It presented to the RCGM its data and conclusions on toxicity and efficacy study of AVDESP.
The company has state of the art R&D facilities at its facility in ITPL, Bangalore. It has developed an integrated approach to bio-sciences spanning genomics, pharmacology, cell and molecular biology and plant biology. This approach was responsible for the discovery of the novel process to produce AVDESP. The novel technology has been patented worldwide by Avesthagen. Based on this patented technology the company is currently negotiating licensing deals with a few pharmaceutical companies including multinational companies. AVDESP is likely to be launched in India by end 2010 and in BRIC (Brazil Russia, India and China) countries by 2011, EU and North America on expiry of current patent.
According to Dr Villoo Morawala-Patell, Founder and CMD, Avesthagen, this is a significant development and promises to bring relief to those suffering from anaemia and terminally ill kidney patients. More importantly, this product will be much more cost effective than the currently available erythropoietin.
It has several patents in its bank of intellectual capital which will be leveraged over the next couple of years for building a worldwide business in biosimilars and other related areas.
The company is India's leading integrated systems biology platform that focuses on achieving convergence of food, pharma and population genetics leading to predictive preventive and personalized healthcare. It employs 400 people worldwide and is headquartered in Bangalore. It has established state-of-the-art laboratory facilities in Bangalore. It began business operations in 2001.Since its inception Avesthagen has grown into one of India's leading healthcare technology group in India, and its activities include, in addition to its agri-biotechnologies product pipeline, development of clinically validated botanical bioActives, derived from Indian medicinal plants, as well as the development of a pipeline of bio-similar drugs.
The company has four strategic business units: bioPharmaceuticals, bioNutrition, bioAgriculture and Science & Innovation. Its partners include multiple top 10 global companies in each of its fields of research. Avesthagen collaborates at every stage in the value chain with appropriate partners, both public and private, for access to and exchange of technology and overall commercial expertise to leverage the 'India advantage'.