AstraZeneca's Crestor will be priced at a 12% discount to the average weighted cost per day of Pfizer's Lipitor .

The average wholesale price of Crestor will be uniform across all dosage strengths, $2.63 per pill for 5 mg, 10 mg, 20 mg or 40 mg. The price is 12% less than the average weighted price per day of $3.10 for Lipitor (atorvastatin) as calculated by AstraZeneca.

FDA approved Crestor (rosuvastatin) Aug. 12 for the treatment of various lipid disorders, including primary hypercholesterolemia (heterozygous familial and nonfamilial), mixed dyslipidemia (Fredrickson Type IIa and IIb) and hypertriglyceridemia (Fredrickson Type IV).

Crestor is also indicated for homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatment or if such treatments are unavailable.

Crestor's discount to Lipitor is even greater when comparing equivalent efficacious doses of the two statins.

In the Crestor studies, reduction in low-density lipoprotein cholesterol with the 10 mg dose in Type IIa/IIb dyslipidemia patients (-46%) was roughly equivalent to 20 mg of Lipitor (-43%). In addition, the 20 mg Crestor (-52%) was slightly more efficacious than 40 mg Lipitor (-48%).

First DataBank's Price Alert lists Lipitor 20 mg and 40 mg doses at $3.64 per pill AWP compared to $2.63 for Crestor 10 mg and 20 mg, for a 28% discount.

Crestor 5 mg through 20 mg will be supplied in 90-count bottles at $236.70 AWP; the 40 mg dose will be supplied in 30-count bottles. A 90-day supply of Lipitor 10 mg is $214.70, and $327.93 for 20 mg, 40 mg and 80 mg strengths.

Although Crestor pricing in some countries is on par with Lipitor pricing, AstraZeneca CEO Tom McKillop noted during a July earnings call that the company approaches Crestor pricing "country by country, depending on market circumstances" ("The Pink Sheet" Aug. 4, 2003, p. 29).

AstraZeneca will also be able to tout a fixed starting dose for Crestor of 10 mg.

The 20 mg dose is reserved for patients with "marked hypercholesterolemia (LDL-C >190 LDL mg/dL) and aggressive lipid targets," labeling states. "Initiation of therapy with 5 mg once daily may be considered for patients requiring less aggressive LDL-C reductions or who have predisposing factors for myopathy."

The recommended start dose for Lipitor is 10 mg or 20 mg, with 40 mg reserved for patients who require more than a 45% reduction in LDL-C. Labeling notes that the dose range is 10 mg to 80 mg and that the starting dose and maintenance doses should be individualized.

FDA's Endocrinologic & Metabolic Drugs Advisory Committee recommended a fixed 10 mg starting dose for the general dyslipidemia population at its July 9 meeting, although it noted that titration would be "ideal" ("The Pink Sheet" July 14, 2003, p. 3).

AstraZeneca has had to shift its strategy for Crestor from claiming "superstatin" status to emphasizing fixed dosing and efficacy at lower doses.

The company has said that a fixed starting dose for Crestor offers a convenience advantage over other statins, which can require titration among a range of doses. The firm also maintains that a lower, efficacious starting dose offers psychological advantages for patients ("The Pink Sheet" April 14, 2003, p. 35).

AstraZeneca's marketing message may be complicated by the fact that Crestor's efficacy cannot be pushed past the highest dose of Lipitor. Crestor 40 mg reduced LDL-cholesterol by 55% in dyslipidemia patients compared to a 51% reduction with 80 mg Lipitor, a difference that was not statistically significant.

AstraZeneca was originally developing an 80 mg dose of Crestor but discontinued the program due to reports of rhabdomyolysis and renal impairment (¹ Also see "AstraZeneca Crestor Plan: Drop 80 Mg, Submit Lower-Dose Data In Q1" - Pink Sheet, 12 August, 2002., p. 27). AstraZeneca has agreed to limit its promotion of the 40 mg dose by not providing samples to health care professionals (see ² Also see "AstraZeneca Agrees To Limit Distribution, Promotion Of Crestor 40 Mg" - Pink Sheet, 18 August, 2003.).

AstraZeneca expects Crestor to be available by the end of August. The company submitted the NDA June 26, 2001; AstraZeneca received an "approvable" letter May 31, 2002.

AstraZeneca Crestor 10 Mg Starting Dose Priced At 12% Discount To Lipitor

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