Venus completes Phase III trials of new Aminoglycoside molecule

Mumbai : Venus Remedies, a leading pharmaceutical manufacturing company, on Wednesday announced the successful completion of Phase III clinical trial of a novel aminoglycoside molecule, Etimicin sulphate.

Etimicin sulphate, for which Venus owns the exclusive manufacturing and marketing rights in India, was licensed from a company in China in 2007.

Dr. Manu Chaudhary, JMD, Venus Remedies Ltd. said: ?Etimicin Sulphate, new generation semi-synthetic aminoglycoside antibiotic has proved to be 50 % safer and more efficacious as compared to other commonly used aminoglycosides. It will provide 25% faster cure rate and is likely to reduce the treatment time.?

Etimicin has captured 80% market share of the total aminoglycoside market in China. Current size of domestic aminoglycoside formulation market in retail segment is INR 6 billion, which is growing at 6-8 percent per annum.

?Venus is expecting to capture the same market share after Etimicin launch in domestic market that is expected in the second quarter of 2011,? 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.