Venus Remedies has achieved yet another milestone by receiving the market authorization for Gemcitabine, one of the key products for the treatment of cancer via decentralized procedure from Medicine and Healthcare Regulatory Agency (MHRA) UK. The other countries in the list are Poland, Germany, Slovenia and Portugal.
Venus is all set to capture substantial market share by entering the highly lucrative market of Europe through its subsidiary Venus Pharma GmbH as it stands amongst the first few to receive the market authorisation for Gemcitabine. Gemcitabine is a $1.5 billion drug world wide with more than 30% market share from Europe.
Gemcitabine is used in the treatment of variety of cancers including cancer of lungs, pancreas, bladder and breast. Gemcitabine, in combination with Cisplatin, recently received US FDA and 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.
It’s the only drug approved and has been established as the gold standard drug therapy for pancreatic cancer (216,000 cases per annum) which has survival rate of 3% and is all set for explosive growth and will remain amongst the choicest of drugs even after becoming generic.
The product is available in two strengths of 200 mg and 1000 mg and both these reports has been approved by UK MHRA authorities. The company will produce Gemcitabine from its EU GMP approved Baddi, facility in India and planned to launch the product in Germany and UK along with other EU countries by second quarter of 2011.