Venus Remedies has successfully completed the phase III clinical trial of a novel aminoglycoside molecule, Etimicin sulphate.
Etimicin
sulphate, for which the company owns the exclusive manufacturing and
marketing rights in India, was licensed from a company in China in
2007.
According to Dr Manu Chaudhary, joint managing director,
Venus Remedies Ltd. Etimicin sulphate, new generation semi-synthetic
aminoglycoside antibiotic has proved to be 50 per cent safer and more
efficacious as compared to other commonly used aminoglycosides. It will
provide 25 per cent faster cure rate and is likely to reduce the
treatment time.
Etimicin has captured 80 per cent market share
of the total aminoglycoside market in China. Current size of domestic
aminoglycoside formulation market in retail segment is Rs.6 billion, which is growing at 6-8 per cent per annum.
“We
are expecting to capture the same market share after Etimicin launch in
domestic market that is expected in the second quarter of 2011,” Dr
Manu Chaudhary added.
Under phase III, trials were conducted on
216 patients suffering from lower respiratory tract infections, skin and
skin structure, surgical and urinary tract infections caused by
pathogens. The results of the trials are very encouraging. The company
has submitted the reports to the DCGI office. The product has undergone
all requisite tests such as sub-acute toxicity studies to establish
safety of the formulation conducted as per OECD guidelines and clinical
trials for efficacy and tolerability as per ICH GCP guidelines.
The
molecule is under patent protection in India, China and major markets
of the world. Etimicin therapy will drastically reduce the potential
risk of nephrotoxicity and ototoxicity caused by conventional
aminoglycosides like Amikacin, Tobramycin, Netilmicin etc.
Venus
Remedies Ltd is research and development driven pharmaceutical
manufacturing company. It is a BSE & NSE listed company with
turnover of Rs.310 crore and is present in 60 regulated and semi-regulated countries..
The
company has two manufacturing locations in India and one in Germany.
Venus is a manufacturer of oncological and cephalosporin injectable
products following EU-GMP norms for all is activities. Its broad range
of products catering to critical care segment include parenterals like
cephalosporins, carbapenems and oncology drugs in lyophilized form,
infusions and small volume parenterals.