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EU awards Venus Remedies patents for anti-infection drug

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BS Reporter New Delhi/ Chandigarh
Last Updated : Jan 21 2013 | 4:48 AM IST

Chandigarh-based listed pharma player Venus Remedies has obtained the European Union patent for its researched anti-infection product “Sulbactomax”. The patent granted by European Patent organisation (EPO) will cover the entire European Union including the United Kingdom, France, Germany, Italy, Spain, and Switzerland.

“This is India’s first researched anti-infection product to get EU patent. It’s a breakthrough from Venus for the world’s biggest regulated market. Sulbactomax, an innovative product of Venus is capable of replacing a larger share of ceftriaxone market, which is the preferred anti-biotic till now. Venus proposes to enter EU market through CTD (Common Technical Document) route and will be able to launch its product in market by 2013. Patent is valid till 2025 and Venus is hopeful of achieving 10 per cent market share i.e. $30 to $40 million by 2015,”said Pawan Chaudhry CMD Venus Remedies Ltd.

Venus is considering tie-ups with multinational companies for out-licensing the product in geographies, where it holds patent for Sulbactomax, Chaudhry said.

Sulbactomax is a novel antibiotic combination of Beta - lactam Ceftriaxone & Beta - lactamase indicated for the treatment of infections of Respirator Tract, Acute bacterial otitis media, Septicemia, Pre-post operative infections, Intra-Abdominal infections, Sexually transmitted diseases and other serious infections caused by betalactamse producing ceftriaxone resistant bacterial strains.

EU patent will give Venus patent access to 37 EU countries. The company already has patent for Sulbactomax from South Africa and India, thereby making a total of 39 countries, out of 51 where it has been filed, which includes US and Japan.

Venus is marketing this product in India and seven other countries outside India at present. Registration is in process in another 10 countries in different continents world wide. Soon, Venus proposes to enter in South African market through CTD route. This will be the first CTD for any research product by Venus in European market. All the studies required for CTD including BA/BE studies, Toxicology and Phase III Clinical trials have been conducted under GLP environment as per EU norms. Currently one more multi centric randomised Phase III clinical trial is going on for this product with additional indications on more than 550 subjects strictly as per GCP guidelines which is expected to be completed by the end of September 2010.

Sulbactomax is the dedicated efforts of research team of Venus Medicine Research Centre, a research arm of the company, located at Baddi, India with a focus on antibiotics research, anti-cancer research and Novel Drug Delivery System.

Venus now has a total patent grant basket of 44 patents out of 341 filed globally. Grant of European patent has led company in different league of innovators recognised internationally.

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First Published: Sep 16 2010 | 12:00 AM IST

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