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Crestor hits 'a bump in the road' as BMS study backfires

Published on 06/04/04 at 05:52pm

AstraZeneca's Crestor has suffered a setback in the US as its share in the highly competitive statin market fell back for the first time following a safety scare.

US consumer watchdog Public Citizen published a petition to have Crestor withdrawn in the first week of March, claiming it had demonstrated the same, sometimes fatal, side-effects which led to the withdrawal of Bayer's Baycol/Lipobay in 2001.

The watchdog said the drug had been linked to cases of life-threatening muscle damage and kidney failure or damage.

It cited the decision by two US health insurers and the Swedish government not to reimburse patients for the drug to back up its argument for it to be taken off the market.

Weekly sales of Crestor dropped by 3% after the petition emerged, checking the drug's otherwise unbroken sales growth this year before they made a modest 0.4% recovery the following week.

Analysts Deutsche Bank dismissed the setback as a 'bump in the road', saying the drug's share of prescriptions was stabilising, and repeated their forecast for Crestor to achieve a 21% share in the US statin market and global sales of $4 billion by 2007.

In a briefing note, the bank said the reported cases of serious side-effects were well within expected limits, and believed that Astra-Zeneca reps had already allayed physicians' fears.

Since its US launch in August 2003, a total of 1.3 million prescriptions have been written for the drug which has won 4% of US statin prescriptions, but it has a long way to go before it threatens the dominance of Pfizer's Lipitor in the market.

To maintain momentum, AstraZeneca has launched a direct-to-consumer (DTC) advertising campaign in the US, which will focus on the drug's best-in-class efficacy message.

AstraZeneca continues to promote its STELLAR study, which shows a 10mg dose of Crestor is significantly superior to pravachol 10-40mg, Zocor 10-40mg and Lipitor 10mg in terms of reducing LDL-C ('bad' cholesterol), claiming that every 3% reduction in LDL-C reduces the risk of cardiovascular complications by 1%.

Meanwhile, a study sponsored by Bristol-Myers Squibb has backfired on the company, showing its statin Pravachol (pravastatin) to be less effective than Lipitor in preventing patient deaths.

The PROVE-IT study found fewer patients on Lipitor died than those taking Pravachol, and showed Pfizer's drug to be particularly beneficial for the early treatment of patients suffering from acute coronary syndrome a - condition covering a range of symptoms including unstable angina or heart attack.

Katy Wynn, cardiovascular analyst at Datamonitor, said: "The trial was originally designed to show non-inferiority between Pravachol and Lipitor, but obviously that backfired, which doesn't happen very often."

Lipitor is likely to benefit most from the study, but Ms Wynn says it is not a disaster for Pravachol because the study reinforced its profile as the safest statin.

Benefiting from years of accumulated clinical trials on Lipitor, Pfizer is now diversifying the endpoints of its studies to promote the breadth of its benefits for patients. The company unveiled new trial results at the ACC  from a three-year study in people with diabetes.

Pfizer said the trial was so successful that it was stopped early due to its positive results among patients with type II diabetes, high blood pressure and elevated cholesterol.

The study showed Lipitor produced a 23% reduction in the number of total cardiovascular events, such as a heart attack or stroke in the patients, setting it up for an extended licence to cover the prevention of coronary or cardiovascular events.

This further proof for the 'wonder drug' status of statins was welcomed cautiously in the UK by The Stroke Association.

"So far the evidence regarding statins reducing the incidence of stroke is not unequivocal," the Association said. "If any treatment is of proven benefit, The Stroke Association would like to see it readily available to stroke patients or those at risk from stroke, throughout the country."

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