AVESTHAGEN's First Biosimilar Molecule AVDESP(TM) Completes Clinical Batch Manufacturing in Malaysia, to Move to Clinical TrialsBy Avesthagen Limited., PRNE
Tuesday, December 7, 2010
BANGALORE, India, December 8, 2010 - 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:
Contact: Anilram Chauhan Email: email@example.com T: +91(0)80-28411665
Anilram Chauhan anilram at avesthagen.com Tel.: +91(0)80-28411665
Tags: Avesthagen Limited., Bangalore, December 8, India