AstraZeneca Crestor 80 Mg Dose Would Have Low Demand, CEO Suggests

AstraZeneca expects that an 80 mg strength of Crestor, if approved, would constitute a small proportion of the product's sales.

CEO Tom McKillop suggested that the vast majority of sales for Crestor (rosuvastatin) will be in lower doses of the cholesterol drug. "The usage we would envisage for 80 mg is going to be exceedingly small...because at 10 mg you've got [approximately] 92% of patients... completely controlled," he told analysts Jan. 31 during ¹ AstraZeneca's 2001 earnings presentation in London.

However, "we know that the 80 mg Crestor can control [cholesterol] for a group of patients who are otherwise not controlled. So for those patients who require 80 mg, we believe it should be available and should be approved at the same time. There is no reason why there should be a difference."

The NDA for Crestor was submitted in June. The 80 mg dose was associated with reports of rhabdomyolysis in Phase III trials. There are no concerns about rhabdomyolysis in the lower doses, AstraZeneca said (² (Also see "AstraZeneca Crestor NDA Includes Rhabdomyolysis Reports At Highest Dose" - Pink Sheet, 10 Dec, 2001.), p. 21).

FDA is likely to take a particularly close look at Crestor's safety following the recent withdrawal of Bayer's Baycol (cerivastatin) due to rhabdomyolysis (³ (Also see "Baycol Withdrawal Gives Boost To Pravachol; Will Crestor NDA Be Affected?" - Pink Sheet, 13 Aug, 2001.), p. 4).

AstraZeneca suggested it may receive an "approvable" letter for Crestor, and said that regardless of the type of response by FDA, the company expects several months of negotiations prior to launch.

"There's quite a debate going on between pharmaceutical companies...[and] the FDA on...how long it is between receiving an approvable letter or an approval even and getting final agreed wording on getting onto the market," McKillop said. "Our experience hasn't been at all bad...and we have not had long delays between approvable letters and getting on the market."

"So if we get a response from FDA in around April, which would be the expectation based on a June [submission] date, and we are saying second half launch, we are really saying we have several months in which to agree [on] any outstanding issues," McKillop said.