14 Jun 2012, BioSpectrum Bureau , BioSpectrum
Bangalore: Venus Remedies, a research-based Indian global pharmaceutical company, has received a patent from the US Patent Office for a new drug product CSE1034, which is an antibiotic adjuvant entity (AAE). It has been found to be effective against a wide range of drug-resistant infections, including the superbugs such as carbapenemase resistant Metallobetalactamses (MBL) strains.
Dr Mufti Suhail Sayeed, vice president, Venus Medical Research Centre, said, "The US patent of CSE 1034 for Venus Remedies is a landmark development for initiating the process of commercialization of this novel drug, designed specifically to target growing bacterial resistance mechanisms."
Venus Remedies is planning to launch this drug in India under the brand name ELORES and is planning to have a pre IND meeting with US FDA for fast track approval of this product.
Dr Manu Chaudhary, joint managing director-VMRC, elaborated about the drug. "This unique antibiotics adjuvant entity creates a synergistic effect due to its activity on AMRINGER (acquired multiple resistance in gram negative enterococci and rods) that stops development and spread of bacterial resistance. Experience with clinical studies on more than 1000 patients have indicated approximately 20-30 percent reduction in cost of therapy compared to conventional therapies being used," said Dr Chaudhary.
World over, antibiotic resistance is beginning to pose a major problem for combating bacterial infections. In India, 10-30% of patients admitted to hospitals and nursing homes contract nosocomial infections, agaisnt which the drug has been found to be effective. Studies conducted in hospitals across India have shown that the novel antibiotic adjuvant entity is suitable for the treatment of a range of infections affecting lower respiratory tract, urinary tract, skin & skin structure, bone & joint and conditions like meningitis, septicaemia, acute otitis media. The drug has been found safe while effectively dealing with hospital acquired (nosocomial) infections involving metallobetalactamase and other resistant strains such as E. coli, K. pneumoniae, P. aeruginosa and A. baumanni, with reduced drug induced toxicity resulting in lesser adverse effects.
Anti-infective pharmaceuticals segment in India is the largest contributor to domestic pharmaceutical sales, contributing around 17percent of the $11 bn (according to the 2011 PwC report) market. The antibiotics segment, which is growing at a pace of over 20% per annum, are estimated to have a share of around 12% in the overall antibiotics market in India.