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AstraZeneca prepares Crestor for battle

Published on 29/10/03 at 10:39am

AstraZeneca's US salesforce is gearing up to launch its potential blockbuster cholesterol-reducing drug Crestor, after receiving a long-awaited FDA approval.

Crestor received its first launch across the border in Canada in February, but the US authority's safety concerns about the drug at high doses have delayed its launch by over six months.

The company is now putting these tribulations behind it as it prepares to take on the market leading statin, Lipitor, and the sales and marketing might of the world's biggest pharmaceutical company, Pfizer.

The Anglo-Swedish company, however, has powerful weapons at its disposal when going into battle against Lipitor proven superior efficacy, and a US price which will undercut Pfizer's product by an average of 13%.

Last month an FDA advisory panel backed data which showed a 10mg dose of Crestor brought 82% of patients' LDL cholesterol levels to target, compared to just 59% of the same dose of Lipitor. AstraZeneca will underline this superior efficacy by emphasising the fact that large numbers of existing statin patients are not reaching their targets.

AstraZeneca will need all of its ace cards to help its US 6,500 salesforce, dwarfed by the 11,000-strong army of sales reps who have made Lipitor the biggest selling drug of all time, generating sales of $8 billion in 2002.

AstraZeneca have appointed Adele Golfo as vice-president of its cardiovascular primary care business in the US, the same man who orchestrated the launch of Lipitor and who is credited with raising awareness of cardiovascular disease in the US.

"It is not just about the size of the sales force, it is about the smartness of the sales force and efficacy of the drug," Mr Golfo told The Guardian. "I don't care if you have a million sales representatives if you don't have a novel drug. We have a highly trained sales force that has proved its ability with the launch of Nexium and other drugs. And historically the market has rewarded the best product."

Pfizer has already launched its own spoiler campaign, choosing to underline the success of Lipitor on the day Crestor gained approval, proudly proclaiming that 21 billion tablets sold worldwide was a "record sign of physician trust."

Pfizer is certain to maintain the emphasis on the proven safety record of its drug, as the withdrawal two years ago of Bayer's statin Lipobay (Baycol in the US) due to sometimes fatal side-effects is still fresh in the memory of many doctors.

Deutsche Bank analysts note that despite the FDA initial concerns, Crestor's labelling is not compromised by safety warnings, and says Pfizer will walk a fine line in pointing out potential side-effects in Crestor, lest physicians fear it is shared by all drugs in the class.

"Obviously the concern [for AstraZeneca] longer-term is that Pfizer trawl through post-marketing surveillance databases looking for renal signs (as they have done on Vioxx and hypertension/CHF), but the lack of growth in the class post-Baycol suggests that Pfizer will wish to avoid sensitising physicians to a new statin side-effect concern unless it comes under huge or irreparable pressure."

Meanwhile, both Pfizer and AstraZeneca will target the vast untreated populations with high cholesterol levels, with existing US patients estimated to be just one third of those who would benefit from the drugs.

Despite Crestor's strengths, analysts do not foresee it becoming the market leader before Lipitor's patent expires, with some forecasting $5 billion in sales by 2007, while Deutsche Bank forecasting a relatively modest $2.5 billion.

Crestor's battle to win market share has been made more difficult by the launch of Schering-Plough and Merck's co-marketed novel cholesterol absorption drug Zetia/Ezetrol, which will eventually be combined into one pill with the latter Zocor, the first statin blockbuster.

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