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

December 8, 2010

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) 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
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.

Source: newswire

comments powered by Disqus