Novartis this morning revealed that it is seeking a new use for its blockbuster aromatase inhibitor Femara (letrozole) in the UK, to treat early breast cancer patients who have already undergone surgery. Although not yet approved, Novartis says Femara could become the first breast cancer treatment to both cut the risk of disease recurrence post-surgery and following standard tamoxifen treatment.
The application includes data from an 8,000 patient head-to-head study – dubbed BIG 1-98 – showing Femara was more effective than tamoxifen in helping women stay free of the disease [[27/01/05d]]. At just over two years, results showed Femara cut the risk of the disease recurring by an additional 19% over that offered by tamoxifen. Furthermore, women who were treated with Femara experienced a 27% reduction in the risk of cancer spreading to other parts of the body compared with tamoxifen, alongside a 14% reduction in the risk of death, although this did not reach statistical significance.
However, AstraZeneca – the developer of tamoxifen – will likely not sit quietly in such an important marketplace. In June, it won UK clearance to market its aromatase inhibitor Arimidex (anastrazole) for postmenopausal women who have undergone surgery for breast cancer [[29/06/05b]], and is currently the only drug in its class to be available for this use.
- Meanwhile, Novartis says it has agreed to settle a lawsuit with shareholder of Eon Labs – the US company is it in the process of acquiring [[21/02/05b]] - which had become a major hurdle in the purchase.
The Swiss company says that the $32 per share offer still stands and will now remain open until July 20. Once all the shares have been tendered and the company secures the green light from the US regulator, it will be well on its way to cementing its position at the top of the global generics league table.