WILMINGTON, Del., Dec. 10 /PRNewswire-FirstCall/ -- The US Food and
Drug Administration (FDA) today issued its final assessment of two small,
open, long-term, clinical studies in patients with gastro-esophageal reflux
disease (GERD), comparing anti-reflux surgery with either omeprazole
(SOPRAN study) or NEXIUM(R) (LOTUS study) treatment.
AstraZeneca (NYSE: AZN) agrees with the FDA conclusion which states
"FDA continues to conclude that long-term use of these drugs is not likely
to be associated with an increased risk of heart problems. FDA recommends
that health care providers continue to prescribe, and patients continue to
use, these products as described in the labeling for the two drugs."
AstraZeneca also supports the conclusion made by the FDA that the overall
benefit/risk profiles of omeprazole and NEXIUM remain unchanged.
AstraZeneca continues to be confident in the safety profiles of omeprazole
and NEXIUM.
The conclusion confirms the public announcement made on August 9, 2007
when the FDA stated that preliminary evaluation of the SOPRAN and LOTUS
data does not suggest an increased risk of cardiac events for patients
treated with omeprazole or NEXIUM. This announcement was in response to a
communication sent to worldwide Health Authorities by AstraZeneca in May
2007 regarding the SOPRAN and LOTUS studies.
PRILOSEC(R)/LOSEC (omeprazole)(*) was first launched outside the US in
1988 and in the US in 1989. NEXIUM was first launched outside the US in
2000 and in the US in 2001. Proton Pump Inhibitors (PPIs) have been shown
to be beneficial for patients with gastroesophageal reflux disease (GERD).
PPIs are generally well tolerated and PRILOSEC/LOSEC and NEXIUM have been
used in the management of GERD in over 1 billion patient treatments.
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the
research, development, manufacture and marketing of prescription
pharmaceuticals and the supply of healthcare services. It is one of the
world's leading pharmaceutical companies with healthcare sales of $26.47
billion and leading positions in sales of gastrointestinal, cardiovascular,
neuroscience, respiratory, oncology and infection products. AstraZeneca is
listed in the Dow Jones Sustainability Index (Global) as well as the
FTSE4Good Index.
In the United States, AstraZeneca is a $12.44 billion healthcare
business with more than 12,000 employees. For nearly three decades,
AstraZeneca has offered drug assistance programs side by side with its
medicines, and over the past five years, has provided over $3 billion in
savings to more than 1 million patients throughout the US and Puerto Rico.
AstraZeneca has been named one of the "100 Best Companies for Working
Mothers" by Working Mother magazine and is the only large pharmaceutical
company named to FORTUNE magazine's 2007 list of "100 Best Companies to
Work For." In 2006, for the fifth consecutive year, Science magazine named
AstraZeneca a "Top Employer" on its ranking of the world's most respected
biopharmaceutical employers.
For more information about AstraZeneca, please visit:
http://www.astrazeneca.com.
About NEXIUM(R) (esomeprazole magnesium)
NEXIUM, launched in the U.S. in 2001, is approved for the treatment of
heartburn and other symptoms associated with GERD, as well as for the
short- term treatment (4 to 8 weeks) in the healing and symptomatic
resolution of diagnostically confirmed erosive esophagitis. For those
patients who have not healed after 4 to 8 weeks of treatment, an additional
4 to 8 week course of NEXIUM may be considered. NEXIUM is indicated to
maintain symptom resolution and healing of erosive esophagitis. Controlled
studies do not extend beyond 6 months.
Common side effects with NEXIUM include headache, diarrhea, and
abdominal pain. Symptom relief does not rule out other serious stomach
conditions.
AstraZeneca is committed to helping people get the medicines they need.
In 2006, 97,614 NEXIUM patients were provided patient assistance through
AstraZeneca programs, which equates to patient savings of $105M.
Nationwide, the majority of people with prescription coverage can get
NEXIUM for less than a dollar a day, based on national average co-pay.
Individual costs may vary.
For more information about NEXIUM, including the US Prescribing
Information please visit: http://www.NEXIUM-us.com .
About PRILOSEC(R) (omeprazole)
PRILOSEC, launched in the U.S. in 1989, was the first in a class of
medications called proton pump inhibitors (PPIs) that block acid production
by inhibiting an enzyme system (hydrogen-potassium ATPase) on the surface
of the stomach's parietal cells.
PRILOSEC is indicated for the treatment of heartburn and other symptoms
associated with gastroesophageal reflux disease. PRILOSEC is also indicated
for the short-term treatment (4 to 8 weeks) of erosive esophagitis that has
been diagnosed by endoscopy.
The efficacy of PRILOSEC used for longer than 8 weeks in these patients
has not been established. If there is recurrence of erosive esophagitis or
GERD symptoms (e.g., heartburn), additional 4 to 8 weeks courses of
omeprazole may be considered. PRILOSEC is also indicated to maintain
healing of erosive esophagitis. Controlled studies do not extend beyond 12
months.
Common side effects with PRILOSEC include headache, diarrhea, and
abdominal pain. Symptom relief does not rule out other serious stomach
conditions.
Please see the full US Prescribing Information for omeprazole at
http://www.astrazeneca-us.com/pi/prilosec.pdf .
(*) Omeprazole is widely available as generic and OTC medication.
AstraZeneca trade names for omeprazole include LOSEC(R), PRILOSEC(R),
Antra(R), Mopral(R)
SOURCE AstraZeneca
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Related links:
http://www.astrazeneca.com.
http://www.astrazeneca-us.com/pi/prilosec.pdf
http://www.NEXIUM-us.com
http://www.prnewswire.com/comp/985887.html/
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Hard, +44 207 304 5322, or Jorgen Winroth, +1-212-579-0506, or
Mina Blair, +44 20 7304 5084, all for AstraZeneca; or Peter
Vozzo, (MedImmune), +1-301-398-4358
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