Venus Remedies Limited, a leading research based Indian pharmaceutical company has received Patent grants for SULBACTOMAX, one of the key research products of company, from Federal Service on Intellectual Property, Patents and Trademarks (ROSPATENT), Russia and State Enterprise Ukrainian Institute of Industrial Property Ukraine. With grant of these patents Venus has SULBACTOMAX patent granted in a total of 41 countries all around the globe.
Dr. Manu Chaudhry, JMD Venus Remedies Ltd. said, “Sulbactomax, an existing 2 million USD product in Ukraine, with the grant of this patent will further strengthen its existence in Ukraine Pharmaceutical market which is growing at the rate of 20.9 per cent CAGR through to 2014.” She added, “The Russian patent has opened doors for Venus to enter the Russian Cephalosporin market of $780m which is the world’s 11th largest pharmaceutical market.”
Sulbactomax is a novel antibiotic combination of Beta-lactam Ceftriaxone & Beta-lactamase inhibitor. A multi-centric Phase III clinical trial on 594 patients has been just completed on Sulbactomax on additional indications like Skin and skin structure infections, Otitis media, Surgical infections, Bone and Joint infections and Septicemia. Sulbactomax along with a chemical vector as third ingredient indicated for the treatment of infections of Respirator Tract complicated and uncomplicated urinary tract infections and other serious infections caused by beta-lactamse producing ceftriaxone resistant bacterial strains.
In addition to Russia, and Ukraine Venus Remedies has secured its entry in EU Antibiotics/Anti infective market by filing EU CTD for its premier research product SULBACTOMAX with Federal Institute for Drugs and Medical Devices, BfArM Germany. Venus received SULBACTOMAX patent in August 2010 and have been able to file its first Research patented drug for marketing in Europe.
SULBACTOMAX was developed following the stringent international guidelines defined for developing a new drug and has undergone for pre-clinical studies such as Acute Toxicity, Sub Acute toxicity, Intravenous, para venous toxicities as per OECD guidelines, pharmacokinetic studies, Efficacy and Safety studies established through a series of microbiological studies carried out as per NCCLS guidelines, along with comparative, randomized phase-III multi-centric clinical studies on 290 patients as per GCP guidelines. Apart from these stringent stability studies on all four zone conditions including reconstitution stability have been carried out. Venus Baddi facility is already approved as per EU GMP for manufacturing of Sulbactomax, where the PV batches were taken last year.
The world Antibiotic market is a $37.14 bn market and is growing with the CAGR of 6.76% and is expected to be $55.18 bn by 2013 out of which Cephalosporins accounts to 27% with sales close to $10 bn. which is expected to grow with an average of 6.8% to be of the magnitude of $13 bn. by 2013. With the EU – CTD filing VRL shall be entering not only the EU Market which accounts to 19% of world sales of Cephalosporins and is considered to be the second largest market for Cephalosporins close to be a $1892m in terms of Sales volumes, but also in countries like South Africa, Russia and Middle East where EU CTD is well accepted.
Sulbactomax is the only product in the category of Intergrated Medicine segment which prevents bacterial resistance and enables breaking of bacterial biofilm produced by cephalosporin resistant bacterial strains. The product reduces adverse drug reactions specially caused by ceftriaxone administration like Pseudolithiasis, Nepholithiasis etc. Venus plans to launch the product in Europe in early 2013 and is expecting to grab a 8-10% of current cephalosporin market share of EU in the very initial years of product launch.
About Venus Remedies Ltd.:
Venus Remedies Ltd is research and development driven pharmaceutical manufacturing company. Among the top 50 Indian Pharma companies of India, the company has outpaced most Indian pharmaceutical companies in its growth and value creation over the past few years.
Driven by a top class team of managers and motivators this organization is counted as one of the most professional companies of India and a preferred place for top innovators and managers to join the bandwagon of the globally significant Indian Pharma industry.
Venus Remedies Ltd is BSE & NSE listed company with turnover of 310 crores (FY 2010) is present in 60 regulated and semi-regulated countries, actively exporting to more than 20 countries.
The company has two manufacturing locations in India and one in Germany. Venus is top class manufacturer of Oncological and Cephalosporin Injectable products following EU-GMP norms for all is activities.
Venus has a broad range of products catering to critical care segment in parenterals like cephalosporins, carbapenems and oncology drugs in lyophilized form, infusions and small volume parenterals.
The research team of Venus has proved itself to be a power house of innovation by filing many international patents for sophisticated formulations of anti-biotics and oncological therapeutics.
In May 2010 Venus has won Gold medal for the best innovation under the India Innovation Growth Program 2010 organized by FICCI, Department of Science and Technology Govt. of India, Lockheed Martin Corporation, IC2 Institute at the University of Texas and Indo-US Science &Technology Forum. Having won this award company will be assisted by US-based Lockheed Martin Foundation and the University of Texas to commercialise its advanced wound care product Ampucare in the US market.
Venus Remedies is aiming to create intellectual property wealth of one billion US dollar.