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Posted on Jun 12, 03:34PM | IBNS
Mumbai, June 12: Venus Remedies Limited, a research based global pharmaceutical company, on Tuesday said it 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 U.S. Food and Drug Administration (FDA) to review drugs designed to target antibiotic resistance as "orphan drugs" to speed up their marketing approval, according to 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 >1000 patients have indicated approximately 20-30pc reduction in cost of therapy compared to conventional therapies being used," Dr. Manu Chaudhary, Joint Managing Director-VMRC, Venus Remedies Limited said.
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 and skin structure, bone and 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.
Infections caused by resistant microorganisms often fail to respond to conventional treatment, resulting in prolonged illness and greater risk of death. In India, 10-30pc of patients admitted to hospitals and nursing homes contract nosocomial infections.
Venus Remedies said it 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 17pc of the USD 11 bn (2011 PwC) market. The antibiotics segment, which is growing at a pace of over 20pc per annum, are estimated to have a share of around 12pc in the overall antibiotics market in India.
Globally, the antibiotics market generated sales of USUSD 42 billion in 2009, representing 46pc of sales of anti-infective agents (which also include antiviral drugs and vaccines) and 5pc of the global pharmaceutical market. However, the antibiotics market is maturing; it showed an average annual growth of 4pc over the past 5 years, out of this US alone contributes35pc of market share which is USUSD 12 billion.
Dr. Arvinder Singh, Neuro-Anaesthesist and Neuro-Critical Care Specialist, Max Superspeciality Hopital, New Delhi quoted "Anti-microbial resistance is increasing day by day and patient coming from different hospital settings have multi-drug resistance pathogen.
Pathogen resistance is increasing against the highest order of antibiotics. It is about whole world but an Indian Company getting patent in US for an innovation is a proud moment. Indian company taking a lead against Antimicrobial resistance is good for our country as we can get cheaper novel drugs."
Antibiotic Resistance in India
Recent surveys have revealed that 70-90 pc cases of resistance to cephalosporin antibiotics through ESBLs for Enterobacteriaceae. Well over 50pc of E.coli and Klebsiella strains are resistant to the commonly used gram negative drugs, (Supplement to JAPI, Dec, 2010).
The incidence of resistance with gram negative bacteria faster than that of gram positive bacteria, Also, there are fewer new and developmental antibiotics against gram negative bacteria, as per The Lancet-ID, 2010, 10.