AVESTHAGEN's First Biosimilar Molecule AVDESP(TM) Completes Clinical Batch Manufacturing in Malaysia, to Move to Clinical Trials

Dec 08, 2010, 12:41 ET from Avesthagen Limited.

BANGALORE, India, December 8, 2010 /PRNewswire/ -- AVESTHAGEN LIMITED, a leading knowledge based life sciences company pioneering the convergence between Food, Pharma and Population Genetics, today announced the completion of manufacturing of the clinical grade material of its first biosimilar molecule- AVDESP(TM) (biosimilar to Darbepoetin alfa), which will now be moving into Clinical Trials. Inno Biologics, Malaysia's biopharma CMO has successfully developed Drug Substance batches for AVDESP(TM) that will be used by AVESTHAGEN for conducting clinical trials after formulation of the Drug Product in India. Avesthagen has also signed a Letter of Intent with Inno Biologics for the commercial manufacture of the two biosimilars- AVDESP(TM) and AVENT(TM).

AVDESP(TM) is used in the treatment of specific types of anemia, like anemia associated with chemotherapy/dialysis, where treatments are long drawn out. The recombinant erythropoietin (EPO) which is currently available as a treatment for anemia is administered 2 to 3 times weekly. Darbepoietin alfa has a longer biological half-life as compared to recombinant erythropoietin allowing a reduction in frequency of injections necessary to maintain the desired levels of systemic haemoglobin. Darbepoietin is an EPO analogue with additional carbohydrate chains which confers a greater metabolic stability and hence the greater half-life than EPO (approximately three fold). This also means that the overall treatment cost is reduced significantly.

Dr. Villoo Morawala-Patell, Founder & CMD, AVESTHAGEN, complimented Inno Bio for timely execution of the project and said, "AVESTHAGEN has a rich pipeline of biosimilars, four of which are already through the RCGM (Indian Regulatory body) for conducting clinical trials. We foresee Inno Biologics playing an important role in meeting Avesthagen's goals in getting biosimilars quickly to the market. We are aware that Malaysia provides a conducive environment for biotech ventures hence we look forward to be a part of the Malaysian mission. We will certainly explore ways to deepen and widen our partnership with Inno Biologics and other Malaysian Government bodies which would be mutually rewarding in the long term."

For development of AVDESP(TM) Avesthagen worked on a cell line to efficiently produce the protein molecule. Avesthagen presented to the RCGM, a Govt. of India regulatory body, its data and conclusions on the toxicity and efficacy study of AVDESP(TM). RCGM approved the results and has directed Avesthagen to approach DCGI for conducting clinical trials.

    For more details: http://www.avesthagen.com/docs/prnov302010.pdf

    Contact: Anilram Chauhan
    Email: anilram@avesthagen.com
    T: +91(0)80-28411665

SOURCE Avesthagen Limited.