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Novartis wins EU approval for Glivec successor

Novartis' new cancer drug Tasigna has won EU approval for the treatment of myeloid leukaemia in patients intolerant or resistant to Glivec

Swiss-based Novartis' new cancer drug Tasigna (nilotinib) has won EU approval for the treatment of myeloid leukaemia in patients intolerant or resistant to Glivec (imatinib).

The company expects Tasigna to eventually replace Glivec and will test efficacy and safety in patients who have not yet been treated with the older drug.

Glivec is Novartis' second best-selling product, with sales in FY06 of USD 2.6bn.

The EU approval follows the US approval of Tasigna by the FDA in October 2007.  

Taken twice a day, Tasigna inhibits production of cancer cells by targeting the Bcr-Abl protein, which is produced by cells containing an abnormal chromosome, thought to be the cause of an overproduction of cancer-causing white blood cells in patients with chronic myeloid leukaemia.

Chronic myeloid leukaemia is one of the four commonest types of leukaemia and causes about 15 per cent of global cases. Tasigna has experienced a rapid path to market, having only been created in August 2002, one year after the launch of Glivec.

Glivec and Tasigna compete with Bristol-Myers Squibb's (BMS) Sprycel (dasatinib), which was launched in both the EU and the US in 2006.

In morning trading on 28 November, Novartis' shares were unchanged on the previous day's close at CHF 62.70. So far in 2007, shares in the Swiss pharmaceutical company have fallen in value by approximately 11 per cent alongside other big EU pharmaceutical entities.

Novartis has said annual US sales of Glivec and Tasigna together could be worth more than USD 3.5bn.

Novartis sued for withholding Tasigna data
In late October 2007, US law firm Coughlin Stoia Geller Rudman & Robbins issued a class action lawsuit against Novartis for allegedly withholding adverse information regarding the company's research into Tasigna.

The plaintiffs claimed that the company failed to disclose adverse information regarding its research into Tasigna, which caused the shares to trade at artificially inflated prices.

The suit was filed in the District Court of New Jersey on behalf of shareholders who purchased the stock between 14 June 2006 and 17 July 2007. On the latter date, Novartis stated in a press release that the FDA had requested a three-month extension in the regulatory review period for Tasigna.

Following the FDA disclosure of the safety data for Tasigna, which the defendants allegedly had known for several months, Novartis' share price fell from USD 55.45 to USD 53.36 in two days, according to the lawyers.

30th September 2008

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