Venus Remedies has received market authorisation (MA) for its anti-cancer product, Docetaxel, the leading research-based global pharmaceutical company that specialises in oncology, cephalosporins and neurosciences said on Tuesday.
The 22-year-old firm’s wholly-owned subsidiary, Venus Pharma GmbH, Germany, has received this MA for Portugal. Venus, which was incorporated in 1989 and coverted into a public limited company five years later, is now set to launch this anti-cancer drug in the market by this year-end, having filed a patent for the product.
Manu Chaudhary, JMD and director (research), Venus Remedies said the grant of European MA for the ready-to-use vial has provided the company a new ground to establish its research capabilities and brand internationally. “We have got MA for its single unit stable, non-infringing, pharmaceutical formulation of Docetaxel, which has lesser impurities in comparison to innovator product,” she said.
The formulation comprises 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 vial would make the administration of the drug easier, but even provide enhanced safety to patient and para-medical staff, Chaudhary said.
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.
Pawan Chaudhary, CMD, Venus Remedies Limited, says, “Seeing 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 Panchkula-headquartered company, which is among the world’s 10 leading fixed dosage injectables manufacturers. has a presence in 60 countries and covers more than 75 products.
As for 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, CIS and LAC. The company has also filed dossiers in many countries where the product is in the process of registration.
Venus Remedies Ltd is BSE & NSE listed company with turnover of 357 crores (FY 2011) is present in 60 regulated and semi-regulated countries, exporting to more than 20 countries.