Venus Remedies Limited, a research based global pharmaceutical company, has received patent from the US Patent Office for a breakthrough antibiotic product.
The new drug product CSE1034 which is an antibiotic adjuvant entity (AAE), has been found to be effective against a wide range of drug resistant infections including the `superbugs’ like carbapenemase resistant Metallobetalactamses (MBL) strains, the company announced.
“The US patent of CSE 1034 for Venus Remedies Limited is a landmark development for initiating the process of commercialization of this novel drug, designed specifically to target growing bacterial resistance mechanisms,” said Dr Mufti Suhail Sayeed, vice president-Venus Medical Research Centre (VMRC), Venus Remedies Limited.
The innovation achieves greater significance at a time medical community worldover, particularly India, is looking for ways to deal with the growing problem of antibiotic resistance. Drug-resistant microbes could well become a threat to human race in the days to come as an increasing number of antibiotics are feared losing out in the battle. Emergence of 'superbugs' like carbapenemase resistant Metallobetalactamses has further complicated the scenario.
Also, there are far fewer new antibiotics in the development pipeline as global drug makers are focusing more on drug candidates with instant block-buster potential to treat cancer and metabolic diseases.
In view of the urgency, the regulatory agencies around the world are currently fast-tracking the approval process of antibiotic drugs. Even the Infectious Diseases Society of America (IDSA) has recommended the US Food and Drug Administration (FDA) to review drugs designed to target antibiotic resistance as “orphan drugs” to speed up their marketing approval, according to Dr Sayeed.
Venus’ drug has a unique profile of action which gives it an edge over all the existing therapies. “This unique antibiotics adjuvant entity creates a synergistic effect due to its activity on AMRINGER (Acquired Multiple Resistance in Gram Negative Enterococci and Rods) which stops development and spread of bacterial resistance. Experience with clinical studies on more than 1000 patients have indicated approximately 20-30 per cent reduction in cost of therapy compared to conventional therapies being used,” Dr Manu Chaudhary, joint managing director-VMRC, Venus Remedies Limited said.
Infections caused by resistant microorganisms often fail to respond to conventional treatment, resulting in prolonged illness and greater risk of death. In India, 10-30 per cent of patients admitted to hospitals and nursing homes contract nosocomial infections.
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.
Anti-infective pharmaceuticals segment in India is the largest contributor to domestic pharmaceutical sales, contributing around 17 per cent of the USD 11 billion (2011 PwC) market. The antibiotics segment, which is growing at a pace of over 20 per cent per annum, are estimated to have a share of around 12 per cent in the overall antibiotics market in India.