Abbott and AstraZeneca Expand Relationship to Include Co-Promotion of CRESTOR(R)
ABBOTT PARK, Ill. and WILMINGTON, Del., Aug. 14 /PRNewswire-FirstCall/
-- Abbott (NYSE: ABT) and AstraZeneca (NYSE: AZN) announced today that they
have entered into an agreement for Abbott to promote AstraZeneca's
CRESTOR(R) (rosuvastatin calcium), a medication used along with diet to
reduce high cholesterol.
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(TM) (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(R) (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 http://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%), myalgia
(3.1%), abdominal pain (2.6%), asthenia (2.5%), and nausea (2.2%).
About AstraZeneca
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
http://www.astrazeneca.com.
About Abbott
Abbott 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's news releases and other information are available on the
company's Web site at http://www.abbott.com.