Clinical studies of the drug on more than 1,000 patients have indicated an over 30% reduction in cost of therapy as compared to conventional therapies
Venus Medicine Research Centre (VMRC), the R&D wing of Venus Remedies, a research-based global pharmaceutical company, has been granted a patent for Elores, an antibiotic found effective against carbapenemase-resistant enterococci bacteria, by the Japanese Patent Office.
The company is expected to launch this product in Japan, the world's second largest pharmaceutical market next to the US, by the end of 2015. Elores, which was launched in the Indian market in January this year, has received tremendous response from the medical fraternity. It has a unique profile of action which gives it an edge over all the existing therapies.
"This unique antibiotic adjuvant entity creates a synergistic effect due to its activity on multi-drug resistant extended spectrum beta lactamase and metallo beta lactamase (ESBL/MBL) producing gram negative bacteria. It prevents the development as well as the spread of bacterial resistance from one species to another. Clinical studies on more than 1,000 patients have indicated an over 30% reduction in cost of therapy as compared to conventional therapies," said Dr Manu Chaudhary, Joint Managing Director, Venus Remedies and Director (Research), VMRC.
Elores was recently recognised as the best innovation of 2013 by a team of experts from Stanford Business School, US, IC2 University of Texas, Austin, US and Lockheed Martin Foundation in collaboration with the union department of science and technology under the Indo-US joint science and technology innovation programme, 2013. It has also been selected among the top eight technologies to be commercialised in the USA. Emerging anti-microbial resistance has become a grave problem worldwide, as evident from the recent statement of UK's chief medical officer that anti-microbial resistance was as important an issue as terrorism. "Elores is a product with proven potential. The Japanese patent has given us exclusivity for the product in one of the world's most important and lucrative healthcare markets up to 2025.
Venus has already filed the common technical document with the European Union (EU) and is on the verge of getting MA grant for the product. Since EU and Japan have an understanding on the regulatory front, the product can be made available in the Japanese market within no time after receiving the MA grant from EU," said Dr Chaudhary.
Venus has received patents for this product from 46 countries, including the US, Australia, New Zealand, Russia, South Africa, South Korea, India and all major economies, including EU constituents. "We expect this product to generate a revenue of around $100 million by 2018. The innovation assumes greater significance at a time when the medical community the world over 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 days to come as an increasing number of antibiotics are feared to be losing out in the battle. There are far fewer new antibiotics in the development pipeline as global drug manufacturers are focusing more on drug candidates with instant blockbuster potential to treat cancer and metabolic diseases. In this complicated scenario, a drug like Elores will prove a boon for the society," said Dheeraj Agrawal, chief financial officer (CFO), Venus Remedies.
Regulatory agencies around the world are currently fast-tracking the approval process of antibiotic drugs. Moreover, the company is assisted by experts from IC2 Texas to get the product fast-track approval under the GAIN (Generating Antibiotics Incentives Now) Act, a legislation recently passed by the US government. The first plasmid-mediated MBL was reported in Pseudomonas aeruginosa in Japan in 1991. In a very short time, MBLs became more frequent and are now widespread.
From an isolated study, it has been established that more than 19% nosocomial infections in Japanese ICUs are ESBL-positive, thus creating a compelling need for a product like Elores. Globally, the antibiotics market generated sales of US $42 billion in 2009, representing 46% of sales of anti-infective agents (which also include antiviral drugs and vaccines) and 5% of the global pharmaceutical market. However, the antibiotics market is maturing. It recorded an average annual growth of 4% over the past five years, out of which the US alone accounted for 35% of the market share ($12 billion), followed by Japan ($10.5 billion). Elores directly addresses a market of US $4 billion against the closest contested competitors category.