Pharmabiz
 

Venus completes phase III trial of new aminoglycoside molecule

Our Bureau, BangaloreWednesday, December 8, 2010, 17:30 Hrs  [IST]

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.

 
[Close]