Novartis India is planning to approach the Drug Controller of India (DCI) for obtaining permission for the use of Femara -- an anti-cancer, letrozole-based formulation for pre-operative treatment of breast cancer in post-menopausal women.
The company's move follows two new clinical trials conducted the world over. The trials showed that Femara will be more effective than Tamoxifen, which is currently used in pre-operative therapy in breast cancer patients. The trials were conducted across 29 countries, including India, at 201 centres in two years.
Ajay S Bhatnagar, head (administration & planning), Novartis Pharma AG -- the parent company of Novartis India -- said the growth of a majority of breast cancer tumours in post-menopausal women are hormone-dependent and respond to endocrine therapy. He said, currently letrozole, an aromatase inhibitor, is being used as a second-line therapy to treat breast cancer in post-menopausal women.
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He said Novartis has already reported the new findings to Switzerland's medical authorities and their sanction to use Femara is expected in the first quarter of the year 2001.
Once approval is received, Novartis India would approach DCI for the same. In India, it is estimated that 2,000 breast cancer incidents are reported every year. The price of Femara in India is Rs 2,000 per strip (30 numbers).
According to Bhatnagar, Novartis AG currently is working on two more anti-cancer formulations - STI571 (trial name) and Zometa - and both are undergoing second and third clinical trials, respectively.
It is expected that both these new formulations would hit the Euopean and the US markets by mid-2002.