Avesthagen to start clinical trials of generic version of darbepoetin alfa AVDESP in India

Avesthagen plans to AVDESP — biosimilar of Amgen’s Aranesp — in India by end of 2010.

Indian biotech company Avesthagen may soon start clinical studies for AVDESP –a therapeutically equivalent generic version of darbepoetin alfa in India.

The Bangalore-based Avesthagen has already been given clearance from the Review Committee for Genetic Manipulation (RCGM) based on the data and conclusions on toxicity and efficacy study of AVDESP submitted.

RCGM is responsible for preparing clinical trial protocols and certifying safety of biotech drugs under the Department of Biotech.

Avesthagen will now approach the Drugs Control General of India (DCGI) to get the formal approval to conduct human studies using its version of darbepoetin alfa in the country.

Darbepoetin alfa is a synthetic erythropoietin that increases red blood cell levels.

Darbepoetin alfa differs from recombinant human erythropoietin (rHu-EPO) in that it contains 5 N-linked oligosaccharide chains and has a molecular weight of 37,100 Daltons and a carbohydrate composition of 51%. These additional chains in darbepoetin alfa result in longer half-life,increased biologic activity, and decreased receptor affinity.

Darbepoetin alfa has a half-life approximately 3 times longer than that of rHu-EPO (erythropoeitin) when given as a single dose by the intravenous route in humans, studies show.

Darbepoetin is currently marketed by biotech major Amgen under the trade name Aranesp.

US FDA approved darbepoetin alfa (Aranesp) for the indication of anemia associated with chronic renal failure in patients on dialysis and patients not on dialysis.

On November 8, 2007, USFDA slapped Aranesp an additional “black box” warnings on the label, following certain safety related concerns with darbepoetin alfa.

Avesthagen worked on a cell line to produce the darbepoetin alfa biosimilar. The entire development of the protein molecule darbepoetin alfa biosimilar was done in house in a short period of 18 months.

Amgen’s erythropoetin (Epogen) and darbepoetin alfa (Aranesp) registered over $6 billion in combined sales in 2006.“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,” stated Dr Villoo Morawala-Patell, founder and CMD, Avesthagen.

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, she said.

Avesthagen has state of the art R&D facilities at ITPL, Bangalore. Avesthagen 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, the company release said.

Besides darbepoetin (AVDESP), Avesthagen has also developed a few other biosimilars in its R&D Lab at  Bangalore. Four among them are ready for trials before being licensed for selling in India.

Avestagen 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.

Avesthagen plans to launch AVDESP in India by end of 2010 and in BRIC (Brazil Russia, India and China) countries by 2011, EU and North America on expiry of current patent.

Avesthagen is an integrated systems biology player that focuses on achieving convergence of food, pharma and population genetics leading to predictive preventive and personalized healthcare.

Avesthagen has four strategic business units: bioPharmaceuticals, bioNutrition, bioAgriculture and Science & Innovation.