Thursday, March 10, 2005

ARIES STUDY COMPARES CRESTOR, LIPITOR

In a study presented at the American College of Cardiology's Annual Scientific Session 2005, researchers compared two doses of AstraZeneca Plc's Crestor (rosuvastatin calcium) with two doses of Pfizer Inc.'s Lipitor (atorvastatin calcium) in African-American patients with hypercholesterolemia.   The African American Rosuvastatin Investigation of Efficacy and Safety (ARIES) study, an open-label trial, enrolled 774 African-American adults with hypercholesterolemia. Following a six-week dietary lead-in, they were randomized to receive either 10 mg or 20 mg of Crestor or 10 mg or 20 mg of Lipitor for six weeks.   Investigators observed a 14 percent reduction of CRP levels in the patients who received Crestor 10 mg. Among those treated with Crestor 20 mg, CRP levels dropped 19 percent.   Treatment with Lipitor 10 mg and 20 mg resulted in an 8 percent and 15 percent decrease in CRP levels, respectively.   A subset of patients with elevated LDL (more than 160 mg/dL and less than 300 mg/dL) and triglyceride levels (less than 400 mg/dL) was also analyzed. Of those who had a baseline CRP level of more than 2 mg/L, Crestor given at the 10 mg and 20 mg doses reduced CRP by 20 percent and 21 percent, respectively. Corresponding rates for Lipitor 10 mg and 20 mg were 12 percent and 20 percent.   "An increasing number of cardiologists believe that CRP may be an important, yet often ignored, diagnostic tool," said study investigator Dr. Keith Ferdinand, medical director of Heartbeats Life Center. "Through the ARIES trial, we have important new information about the changes caused by Crestor on this potentially critical biomarker in African-Americans."

Tuesday, November 16, 2004

IN BRIEF: ASTRAZENECA PLC

AstraZeneca Plc is in talks with European regulators regarding introduction of a 5 mg dose of its cholesterol-lowering pharmaceutical brand Crestor (rosuvastatin), Reuters reported. At the time Crestor received approval in most European countries, AstraZeneca committed to introducing a lower-dose version of the drug, which currently has a starting dose of 10 mg. Discussions continue as to whether 5 mg should be the standard Crestor starting dose and, if so, what patient population should be targeted. According to Reuters, industry analysts have suggested that Crestor could be less effective at a lower starting dose, which could adversely affect sales.

Tuesday, May 18, 2004

ASTRAZENECA ISSUES WARNING LETTER TO BRITISH PHYSICIANS REGARDING OFF-LABEL CRESTOR USE

AstraZeneca Plc issued a warning letter to British physicians regarding off-label prescribing of its statin Crestor (rosuvastatin), Reuters reported.   After discovering four cases of rhabdomyolysis--a muscle toxicity condition that can lead to kidney damage--among high-dose Crestor users, the company cautioned physicians to adhere to indications on the label and not begin patients on high doses of the drug.   AstraZeneca advised that patients be administered 10 mg doses of Crestor initially and be increased to 20 mg or 40 mg doses only as required.   The rate of adverse events from Crestor use was similar to the side effect profile observed in other competing statins. The four cases of rhabdomyolysis occurred after patients were initiated on a high Crestor dose, according to AstraZeneca spokeswoman Kirsty Walker.   JP Morgan analyst Craig Maxwell noted that the liver damage concerns did not appear alarming and he believes his Crestor global sales projection of $3.5 billion by 2008 will hold true, Reuters added.

Wednesday, August 20, 2003

ASTRAZENECA TO OFFER FLAT PRICING FOR ALL CRESTOR DOSES

AstraZeneca Plc said it will develop a flat pricing strategy for Crestor (rosuvastatin) as it plans to enter the competitive statin market, which already holds two of the world's best-selling prescription drugs, The Wall Street Journal reported.   According to the Journal, AstraZeneca's starting price for each formulation of Crestor will be $2.62 per tablet. The drug, taken once daily, comes in 5 mg, 10 mg, 20 mg and 40 mg doses.   By comparison, a 10 mg starting dose of Pfizer Inc.'s Lipitor (atorvastatin) costs $2.47 per tablet, but the price jumps to $3.64 for the 20 mg, 40 mg and 80 mg strengths.   According to Goldman Sachs, the weighted list price for Lipitor is $3.02. The weighted list price for Bristol-Myers Squibb Co.'s Pravachol (pravastatin) is $3.85, while the price for Merck & Co. Inc.'s Zocor (simvastatin) is $4.27.   Despite the pricing strategy, AstraZeneca recognized that it still faces hurdles with the pharmacy benefit managers. AstraZeneca said it will soon begin its negotiations with PBMs for discounts and rebates.   AstraZeneca acknowledged that under its flat pricing plan it will assume a financial risk if a patient needs to increase their dose of Crestor in order to reach cholesterol goals.   "We did an awful lot of pricing research," David Brennan, president and chief executive officer of AstraZeneca's North American drug business, told the Journal. "We figured we'd get a reasonable price and the customer would get a good value."

Thursday, August 14, 2003

FDA APPROVES ASTRAZENECA'S CRESTOR CHOLESTEROL-LOWERING THERAPY

The Food and Drug Administration approved AstraZeneca Plc's statin Crestor (rosuvastatin) as an adjunct to diet for the treatment of various lipid disorders, inclucing primary hypercholesterolemia, mixed dyslipidemia and isolated hypertriglyceridemia.   Crestor's development program was the largest ever submitted to initially evaluate a statin, including more than 24,000 patients, according to AstraZeneca.   Included in the program were data from a comparative study involving approximately 2,200 patients, which showed that Crestor, in doses of 10 mg to 40 mg, reduced LDL cholesterol by between 46 percent and 55 percent. Pfizer Inc.'s Lipitor (atorvastatin; dosed between 10 mg and 80 mg) lowered LDL cholesterol levels by 37 percent to 51 percent, while Merck & Co. Inc.'s Zocor (simvastatin; 10 mg to 80 mg) reduced LDL cholesterol by between 28 percent and 46 percent. Bristol-Myers Squibb Co.'s Pravachol (pravastatin; 10 mg to 40 mg) lowered LDL cholesterol levels by 20 percent to 30 percent.   Researchers also analyzed the efficacy of Crestor in a six-week dose-ranging study using 5 mg, 10 mg, 20 mg and 40 mg doses of the therapy. Results showed that Crestor reduced LDL cholesterol by between 45 percent and 63 percent compared with a 7 percent reduction in patients administered placebo.   Crestor also increased HDL cholesterol by between 8 percent and 14 percent compared with an increase of 3 percent in the placebo group.

Thursday, July 10, 2003

FDA ADVISORY COMMITTEE UNANIMOUSLY RECOMMENDS ASTRAZENECA'S CRESTOR FOR APPROVAL

Members of the Endocrinologic and Metabolic Advisory Committee to the Food and Drug Administration unanimously voted to recommend approval for AstraZeneca Plc's Crestor (rosuvastatin) as an adjunct to diet for the treatment of patients with various types of lipid disorders including isolated hypertriglyceridemia, mixed dyslipidemia and hypercholesterolemia.   Crestor's development program was the largest pre-approval program for a new statin ever submitted, the company said. AstraZeneca's Crestor safety database includes more than 12,500 patients, more than 4,000 of whom received the 40 mg dose of the treatment.   The class of cholesterol-lowering drugs called statins is expected to generate approximately $20 billion in annual sales this year, according to Dow Jones. Pfizer Inc.'s pharmaceutical brand Lipitor (atorvastatin) currently leads the drug class, having amassed nearly $8 billion in 2002 sales.   Crestor is already approved for use in 24 countries, but U.S. approval was delayed by concerns over side effects similar to those linked with Bayer AG's Baycol (cerivastatin), a cholesterol-lowering drug that was pulled from the market in 2000 after several patients developed the muscle-wasting disease rhabdomyolysis.   "We believe that once approved, Crestor will provide patients who are untreated or not at their target cholesterol levels with an important new treatment option in the control of elevated cholesterol," said Howard Hutchinson, vice president of clinical research at AstraZeneca.