Avesthagen to manufacture biogenerics Avent and Avdesp in Malaysian firm Inno Biologics

Avesthagen, an India-based biotech firm, will soon conduct clinical studies of its two biogenerics products Avent and Avdesp in India.

Avesthagen Limited has started manufacture of two of its biosimilars at Inno Biologic’s Putra Nilai facilities in Malaysia.

Avdesp, the first product for anaemia, has already completed preclinical studies and is ready for cGMP manufacturing for conducting clinical trials in India.

Avesthagen plans to launch Avdesp — –a therapeutically equivalent generic version of darbepoetin alfa biosimilar of Amgen’s Aranesp — in India by end of 2010.

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.

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.

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.

The second biosimilar Avent for auto-immune disorders will also be produced at the Inno Biologics facility.

Inno Biologics has been contracted to produce clinical grade material of Avesthagen’s biosimilars, which will be used for human trials.

Avesthagen has built a pipeline of eight biosimilars of which four are in an advanced stage of development.

“Inno Biologics has shown a willingness to adapt and be flexible in responding to our needs,”according to Dr Villoo Morawala Patell, founder, chairperson & managing director of Avesthagen,

Avesthagen which started operations in 2001 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. It 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.