Venus Remedies, a leading research based global pharmaceutical company, plans to launch anti-cancer drug, Docetaxel, in Portugal by December. The company’s wholly-owned subsidiary, Venus Pharma GmbH, Germany, has already received the mandatory market authorisation (MA) approval in this regard from the government of Portugal. According to Dr Manu Chaudhary, JMD and Director, Research, the company has also filed patent application for Docetaxel.
“The grant of European market authorisation for Docetaxel, ready to use vial, provides a new ground to Venus 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 consists of non aqueous solvents in order to trap Docetaxel in a Micelle, along with a pharmaceutically acceptable stabiliser 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, Chaudhary 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.
“Looking at 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,” Pawan Chaudhary, CMD of the company said.
The versatile 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 and CIS countries. 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.