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 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.
11th largest pharmaceutical market.”
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