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Novartis to challenge AstraZeneca

Swiss firm to launch head-to-head phase III trial between Femara and Arimidex
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Swiss group Novartis AG has launched a double salvo at AstraZeneca (AZ) by initiating a head-to-head phase IIIb trial comparing its breast cancer drug, Femara (letrozole), with AZ's class-leading, £657m-a -year treatment, Arimidex (anastrozole).

The announcement from Novartis came shortly after the company received European marketing approval in Germany, under the mutual recognition procedure, for Femara in the post-surgical treatment of postmenopausal women with hormone-sensitive early breast cancer (adjuvant setting).

Both drugs are aromatase inhibitors, a class whose profile has increased on the back of trial results that showed improvements over standard tamoxifen therapy, though Femara is the only such drug to be approved for use as an initial treatment, immediately after surgery or following five years of tamoxifen therapy, according to Novartis.

The new multi-country trial (Femara vs Anastrozole Clinical Evaluation, or FACE) is an open-label study to compare the efficacy of Femara directly with its rival in up to 4,000 `node-positive' postmenopausal women with early breast cancer, a higher-risk patient population in which once-a-day Femara has proven so far to be particularly effective, Novartis has pointed out.

AstraZeneca, whose aromatase inhibitor Arimidex gained approval for the same indication in June 2005 in Europe, has questioned the power of Novartis' planned trial - whose final results may not be released for several years - reportedly hailing the announcement as not much beyond 'a marketing move'.

ìIt is worth noting that Novartis has tried this tactic before,î Alex Grosvenor, senior life sciences analyst at Wood Mackenzie, told Pharmaceutical Marketing. ìIn 2002, it published results from a head-to-head trial showing that 50 per cent more women respond to Femara than Arimidex in advanced breast cancer (as first-line treatment). [However] in December 2004, AZ published five-year follow-up data (in the adjuvant setting) which were compelling.î

He added: ìThis lengthy track record is an advantage for AZ in the marketing tussle with Novartis.î

Defending the majority market share of Arimidex, which seemingly nets AZ more than double the revenue Femara currently elicits for Novartis in this sector, a spokesperson for the Anglo-Swedish firm told the Wall Street Journal: ìThere is no scientific rationale for doing thisî - highlighting the potential bias that can appear in some open-label trial formats.

Novartis has showcased robust confidence in Femara, with president and CEO of oncology, David Epstein, sticking rigidly to the anticipation that the product will become a blockbuster (ie, generating in excess of $1m a year in sales) by 2008. The key aim of the trial, the company said, is to 'better define the optimal treatment' for node-positive patients.

Epstein said that the benefits of aromatase inhibitor tamoxifen had moved ìphysicians and patientsî to ask which drug in this class is the most effective in the adjuvant setting.

ìThis is why Novartis has made a significant contribution to sponsor the FACE trial,î he added.

However, while Novartis is planning a five-year follow-up to FACE, doubts remain over the length of time it will take to produce useable results.

ìNovartis clearly believes Femara is more effective in the adjuvant setting, which is why it is embarking on the FACE trial. But those results are not expected until 2008, by which time Arimidex is still likely to have a yawning advantage in terms of sales,î said Grosvenor.


30th September 2008


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