Venus Remedies, a leading research based global pharmaceutical company has bagged a Market Authorization (MA) for its anti cancer product, Docetaxel. The company's wholly-owned subsidiary, Venus Pharma GmbH, Germany has received this MA for Portugal. Venus is all set to launch this anti-cancer drug in this market by end of 2011 and it has also filed a patent for this product.
Commenting on this, Dr Manu Chaudhary, JMD and director- research, Venus Remedies said that grant of European Market Authorization for Docetaxel, ready-to use vial, provides a new ground for the company to establish its research capabilities and brand internationally.
Venus has got MA for its single unit stable, non-infringing, pharmaceutical formulation of Docetaxel which has lesser impurities in comparison to innovator product.” The formulation comprises of non aqueous solvents in order to trap Docetaxel in a Micelle, along with a pharmaceutically acceptable stabilizer to adjust the pH of the formulation. The launch of this ready to use vial will not only make the administration of the drug easier but at the same time provides enhanced safety to patient and para-medical staff, she added.
A semi-synthetic cytostatic taxane analogue, Docetaxel was initially developed by sanofi-aventis and is marketed under the brand name 'Taxotere'. The molecule patent protection of sanofi-aventis has recently expired in major European countries while in rest of the countries, the expiry of patent is due in November 2013. This recent patent expiry has further enhanced the prospects for Venus Remedies to market Docetaxel and capture a significant market share where at present the European market of Docetaxel is worth around $1.6 billion.
According to Pawan Chaudhary, chairman cum managing director, Venus Remedies Limited viewing the market size of the product in the European Union with its potential for further growth, we have plans to build Docetaxel a 10 million Euro product by 2014.”
The anti cancer drug is considered as one of the largest oncology products, which is used mainly for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, head and neck cancer and ovarian cancer.
Currently, Venus is marketing Docetaxel under the brand name Doxol in various emerging markets of Africa, Asia, CIS and LAC. The company has also filed dossiers in many countries where the product is in the process of registration.
Besides this product, the company is also contributing successfully in the oncology segment for Europe through its wide array of key products, which includes Paclitaxel, Gemcitabine, Oxaliplatin, Irinotecan and Topotecan. It is estimated that the anti-cancer market size for the world will reach to $103.9 billion by 2012.