Press Release
Abbott and AstraZeneca Expand Relationship to Include Co-Promotion of CRESTOR®
August 14, 2008
Abbott Park, Illinois and Wilmington, Delaware – Abbott (NYSE: ABT)
and AstraZeneca (NYSE: AZN) announced today that they have entered into an
agreement for Abbott to promote AstraZeneca's CRESTOR® (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™
(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).
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
www.astrazeneca.com.
About Abbott
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.
Media:
Abbott: Elizabeth Hoff
AstraZeneca: Donna Huang |
847-935-4236
302-885-6396 |
elizabeth.hoff@abbott.com
donna.huang@astrazeneca.com |
Investor:
Abbott: Larry Peepo
AstraZeneca: Mina Blair |
847-935-6722
44-20-7304-5084 |
larry.peepo@abbott.com
mina.blair@astrazeneca.com |
