Venus Remedies Limited has received patent grants for Sulbactomax, from Federal Service on Intellectual Property, Patents and Trademarks (Rospatent), Russia and State Enterprise Ukrainian Institute of Industrial Property, Ukraine. With the grant of these patents, Venus holds the Sulbactomax patent in 41 countries globally.
According to Dr Manu Chaudhry, JMD Venus Remedies Ltd., Sulbactomax is valued at US$ 2 million in Ukraine and now with the grant of this patent the product will further strengthen its existence in Ukraine.
Pharmaceutical market is growing at the rate of 20.9 per cent CAGR through to 2014. “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,” she added.
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 has 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 billion market and is growing with the CAGR of 6.76 per cent and is expected to be $55.18 billion by 2013 out of which Cephalosporins accounts to 27 per cent with sales close to $10 billion which is expected to grow with an average of 6.8 per cent to be of the magnitude of $13 billion by 2013. With the EU – CTD filing VRL shall be entering not only the EU market which accounts to 19 per cent of world sales of Cephalosporins and is considered to be the second largest market for Cephalosporins close to be a $1892 million 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 integrated 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 per cent of current cephalosporin market share of EU in the very initial years of product launch.