Venus Bags its First Swiss Marketing Authorisation for Gemcitabine

• Being among the first few pharma firms to receive marketing authorisation for Gemcitabine, an oncology drug, and the first Indian company to get marketing approval for this product from Switzerland, Venus Remedies enjoys a competitive edge over other players and is all set to capture a substantial share in the Swiss market for Gemcitabine

• Company planning to launch the product in early in the next quarter of this fiscal year

• This achievement has once again proved the companys expertise in developing world-class products, 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 Limited, a leading research-based global pharmaceutical company, has achieved yet another landmark by securing its first marketing authorisation in Switzerland from Swiss drug authority Swissmedic for Gemcitabine, an oncology drug, through Venus Pharma GmbH, its Germany-based subsidiary.

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 companys 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.

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.

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 3% and has been established as the gold-standard drug therapy for this form of cancer. 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.

About Venus Remedies:

Venus Remedies, headquartered in Panchkula, Haryana (India), is among the 10 leading fixed-dosage injectable manufacturers in the world. The company has three manufacturing units, in Panchkula, Baddi (both India) and Werne (Germany) and 11 overseas marketing offices, including a presence in the US and Germany.

The manufacturing units are certified for ISO 9001, ISO 14001, ISO 18001 and OHSAS. The company has also been approved by EUROPEAN-GMP, WHO-GMP, Latin American GMP (INVIMA), Ukrainian GMP, Zimbabwe GMP, Uganda GMP, Syrian GMP, Columbian GMP, Kenya GMP, Yemen GMP, Saudi Arabian GMP and Iranian GMP, among others.

Venus Remedies has been ranked 107th in Asia (source: Bio Spectrum Asia) and among the 500 largest pharmaceutical manufacturing companies in the world (source: Plimsoll Worldwide Business Intelligence Report).

Venus has won over 102 patents for its innovative research products worldwide. The company has presence in 60 countries and covers more than 75 products.

About Venus Medicine Research Centre:

The Venus Medicine Research Centre (VMRC) located at Baddi, Himachal Pradesh, is a fully equipped interdisciplinary drug discovery and development centre, duly approved by the Department of Scientific and Industrial Research (DSIR), Government of India.

The VMRC is committed to developing therapeutics to meet the challenges of antimicrobial resistance, and has come up with many solutions. It has achieved significant breakthrough in small molecule research for developing products helpful in combating antimicrobial resistance, utilising novel targets and adjuvants which synergise with other antibiotics and minimising potential for resistance. Significant breakthroughs have been achieved by the VMRC in antibiotic adjuvant entities for notable resistance barriers like ESBLs, "plasmid encoded carbapenem resistant metalo-beta-lactamases", methicillin-resistant staphylococcus aureus (MRSA), bacterial biofilms and C. difficile infection.

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Amardeep Singh Tiwana

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