Under the terms of the agreement, Abbott will obtain the non-exclusive right to promote CRESTOR alongside AstraZeneca in the United States, excluding Puerto Rico. Specific financial terms were not disclosed.
CRESTOR is a once-daily prescription statin medication indicated for use as an adjunct to diet in the treatment of various lipid disorders including primary hyperlipidemia, mixed dyslipidemia and isolated hypertriglyceridemia, and to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to lower Total-C and LDL-C to target levels. CRESTOR is available in a 5-, 10-, 20-, and 40-mg dose.
"Abbott's dyslipidemia portfolio includes a number of therapies to help physicians manage a patient's total lipid profile," said Nicole Mowad-Nassar, divisional vice president, Primary Care, Abbott. "With robust clinical data to support its use in managing cholesterol, CRESTOR is another important therapeutic option we can now offer physicians."
This agreement is the second collaboration between AstraZeneca and Abbott. In 2006, the companies announced an agreement to develop a fixed-dose combination of the active ingredients in Abbott's investigational TriLipix™ (fenofibric acid) and AstraZeneca's CRESTOR, with plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in 2009. An NDA for TriLipix for use as monotherapy and in combination with statins has been submitted to the FDA and is currently under review.
"This agreement will allow AstraZeneca to increase share of voice for CRESTOR among physicians whose patients may benefit from this therapy. We see this as a good fit for both companies as this agreement allows us to leverage Abbott's established presence in the dyslipidemia space," said Mike Tilton, vice president of Primary Care, AstraZeneca.
About CRESTOR® (rosuvastatin calcium)
CRESTOR is indicated as adjunct to diet to reduce elevated total-C, LDL-C, ApoB, nonHDL-C, and triglycerides and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia, and to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to lower Total-C and LDL-C to target levels. CRESTOR has not been determined to prevent heart disease, heart attacks, or strokes. For patients with hypercholesterolemia and mixed dyslipidemia, the usual recommended starting dose of CRESTOR is 10 mg. The 40-mg dose of CRESTOR is reserved only for those patients who have not achieved their LDL-C goal utilizing the 20-mg dose of CRESTOR once daily. When initiating statin therapy or switching from another statin therapy, the appropriate CRESTOR starting dose should first be utilized, and only then titrated according to the patient's individualized goal of therapy. AstraZeneca licensed worldwide rights to CRESTOR from the Japanese pharmaceutical company Shionogi & Co., Ltd.
For more information about CRESTOR, including full Prescribing Information, visit www.crestor.com.
Important Safety Information about CRESTOR
CRESTOR is contraindicated in patients with a known hypersensitivity to any component of this product and in patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels, in women who are or may become pregnant, and in nursing mothers. Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with drugs in this class, including CRESTOR. These risks can occur at any dose level but are increased at the highest dose (40 mg). The risk of myopathy during treatment with CRESTOR may be increased with concurrent administration of some other lipid-lowering therapies (fibrates or niacin), gemfibrozil, cyclosporine, or lopinavir/ritonavir. Combination therapy with rosuvastatin and gemfibrozil should be avoided. CRESTOR should be prescribed with caution in patients with predisposing factors for myopathy, such as renal impairment, advanced age, and inadequately treated hypothyroidism. Patients should be advised to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. It is recommended that liver enzyme tests be performed before and at 12 weeks following both the initiation of therapy and any elevation of dose, and periodically (e.g., semiannually) thereafter. The most frequent adverse reactions thought to be related to CRESTOR were headache (3.7 percent), myalgia (3.1 percent), abdominal pain (2.6 percent), asthenia (2.5 percent), and nausea (2.2 percent).
AstraZeneca is a major international healthcare business engaged in research, development, manufacturing and marketing of prescription pharmaceuticals and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection product sales. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. For more information visit www.astrazeneca.com.
Abbott (NYSE: ABT) is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals and devices. The company employs more than 68,000 people and markets its products in more than 130 countries.
Abbott: Elizabeth Hoff
AstraZeneca: Donna Huang
Abbott: Larry Peepo
AstraZeneca: Mina Blair