Venus Remedies has received its first marketing authorisation in Switzerland from Swiss drug authority Swissmedic for Gemcitabine, an oncology drug, through Venus Pharma GmbH, its Germany-based subsidiary.
Gemcitabine is a first-line anti-cancer drug which is used in the treatment of a variety of cancerous conditions, including the cancer of the lungs, pancreas, bladder and breast. Gemcitabine, in combination with Cisplatin, received US-Food and Drug Administration (FDA) and European Medicines Agency (EMEA) approvals as a first-line treatment for lung cancer, which is the most common form of cancer worldwide and accounts for 1.2 million fresh cases annually.
This marketing approval for Gemcitabine 200 mg and 1 g injections will help Venus Remedies further strengthen its oncology portfolio and improve its presence in the oncology space. The company is planning to launch the drug early in the next quarter of this fiscal year. The product will be launched in Switzerland by Swiss Pharma GmbH, with which Venus has a marketing tie up.
Being among the first few pharma firms to receive marketing authorisation for Gemcitabine and the first Indian company to get marketing approval for this product from Switzerland, Venus enjoys a competitive edge over other players and is all set to capture a substantial share in the Swiss market for Gemcitabine. The launch of this product will add to the company’s top line and bottom line in the coming quarters.
This achievement has once again proved the company’s R&D capabilities and its expertise in developing world-class products with regulatory might, considering that the dossier was developed as per international guidelines, as a generic against the originator’s product (Gemzar of Eli Lilly’s, a major global pharma player).
Venus Remedies has already received more than 20 marketing approvals for Gemcitabine injection from various countries. The product is being sold in UK, Poland and Germany. Riding on this marketing approval from Switzerland, the company is expecting to generate good revenue this year.
According to the European Cancer Observatory, 2,16,000 cases are diagnosed with pancreatic cancer per annum, of which 77,940 died in 2012 alone. The mortality of pancreatic cancer is high, making it the fourth deadliest cancer for both men and women. All set for explosive growth, Gemcitabine remains amongst the choicest drugs even after becoming generic. It is the only approved drug for pancreatic cancer that has a survival rate of below three per cent and has been established as the gold-standard drug therapy for this form of cancer.
EP News Bureau– Mumbai