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Venus launches US patent protected product Elores in India It is a novel antibiotic adjuvant entity enus Remedies recently launched CSE1034 under the brand name “Elores”. It is a novel Antibiotic Adjuvant Entity (AAE) to combat antimicrobial resistance caused by MDR, ESBL producing strains. The product was launched by Dr KN Parsad, Associate Professor, Department of Microbiology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow at Manthan 2013, a seminarcum-workshop organised by 'Venus Medicine Research Centre' (VMRC). At the unveiling ceremony of Elores, Dr Manu Chaudhary, Joint Managing Director and Director Research, Venus Remedies said, “Receiving a US patent for Elores was a landmark development to initiate the process of commercialisation and today we are launching it in India as Elores.” Designed specifically to target growing bacterial resistance mechanisms, Elores has a unique profile of action which gives it an edge over all the existing therapies. This unique antibiotics adjuvant entity
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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. Chaudhary further added that the product is effective against Metallo betalactamases (MBL) producing pathogens which are not susceptible to most of the existing antibiotics. It is also unique in its way that it not only kills resistant pathogens (bacteria) but also prevents the spread of resistance. Elores consists of a third generation cephalosporin, a beta lactamase inhibitor along with non antibiotic adjuvant disodium edetate for intravenous administration. It is effective against MDR pathogen producing ESBLs, MBLs like NDM-01, increases cell permeability while working on cell impermeability mechanism of MDRs, regulate efflux pump over expression, breaks bacterial biofilms, prevents transfer of resistant plasmid and hence the spread of resistance is controlled. The company is positioning Elores as the need of the hour as it would be able to
reduce a minimum of 30 per cent of the hospitalisation cost and almost 50 per cent of the drug cost, thereby proving to be very beneficial for patients. As per a study conducted in Delhi, patients with hospital-acquired infections experienced a significantly longer hospital stay (mean: 22.9 days); significantly longer intensive care unit (ICU) stay (mean: 11.3 days); a significantly higher mortality (mean: 54 per cent) and cost significantly more (mean: $14, 818) than controls. So, Elores would be able to curtail these statistics. It took Venus almost 10 years of constant hard work and dedication to develop this breakthrough technology. The company has conducted clinical trials phase I, II and III successfully on a large patient population of 654 patients to prove clinical efficacy and safety in ESBL/ MBL resistant pathogens. On an average, the company has spent 10 per cent of its revenue on research and has been investing almost 20 per cent of its R&D expenditure for developing and establishing this technology itself. Pawan Chaudhary,
Chairman and Managing Director, Venus Remedies said, “Elores is a novel product with a unique technology specifically addressing the compounding medical emergency of antimicrobial resistance, and thus there is no direct competition as such. However, products like meropenem and pipracillin+tazobactum are the closest in contested category though they are also getting huge resistance.” Chaudhary further said, “We want to cater to this segment effectively and immediately and are expecting to capture 10 per cent share of the total AMR market in India in the next five years, making it an over `2.0 billion product. Apart from the domestic marketing plans, we are also in talks with leading pharma companies to launch the product in US as well.” Furthermore, Elores has already secured patents from all over the world including countries like US, EU (37 European countries), Australia, and Russia. The company is awaiting registration grant for Elores with European regulatory bodies to commercialise it in the EU as well. EP News Bureau – Mumbai
approvals including two from Aurolife Pharma and 25 tentative approvals) from US FDA. The company has also received to manufacture and market oxacillin for injection USP, packaged in 1g and 2g vials (ANDA 201539) and oxacillin for injection USP 10g/vial pharmacy bulk package (ANDA 201538). The products are ready for launch. Oxacillin for injection USP is a sterile semisynthetic penicillin (SSP) indicated in the treatment of infections caused by penicillinase
producing staphylococci which have demonstrated susceptibility to the drug. These ANDAs have been approved out of unit XII formulation facility in Hyderabad, India and will be marketed and sold by Aurobindo's US subsidiary AuroMedics Pharma LLC. Aurobindo now has a total of 174 ANDA approvals out of total 149 is final approvals including two from Aurolife Pharma LLC and 25 tentative approvals from US FDA. EP News Bureau – Mumbai
Aurobindo Pharma receives two final approvals the approvals are for felodipine ER and oxacillin injection urobindo Pharma has received final approval from the US FDA to manufacture and market Felodipine Extended-release tablets USP 2.5mg, 5mg, and 10mg. (ANDA 203417) and oxacillin for injection USP. Felodipine Extendedrelease tablets USP 2.5mg, 5mg, and 10mg is the generic equivalent of AstraZeneca’s Plendil Extended-release tablets, 2.5mg, 5mg and 10mg and
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indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. The annual sale of the product is approximately $64 million for the twelve months ending March 2012 according to IMS. The product has been approved out of Unit VII (SEZ) formulations facility in Hyderabad. Aurobindo now has a total of 172 ANDA approvals (147 final www.expresspharmaonline.com
February 1-15, 2013