WILMINGTON, Del., July 1 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE:
AZN) today announced that the US District Court for the District of New
Jersey has granted the company's Motion for Summary Judgment of No
Inequitable Conduct. AstraZeneca had sued Teva Pharmaceutical Industries
Ltd. and Sandoz, Inc. alleging infringement of AstraZeneca's patent as a
result of Teva's and Sandoz's filings of Abbreviated New Drug Applications
(ANDAs). The ANDAs sought approval to market generic versions of
SEROQUEL(R) (quetiapine fumarate) tablets in the US before SEROQUEL's
patent expires in 2011. Since the Court granted AstraZeneca's motion for
Summary Judgment of No Inequitable Conduct in its entirety, trial is
unnecessary.
"We are pleased with the Court's decision to uphold our valid
intellectual property. SEROQUEL remains an important part of our company's
portfolio benefiting patients and physicians throughout the world," said
David Brennan, CEO of AstraZeneca.
AstraZeneca's Motion for Summary Judgment of No Inequitable Conduct
sought judgment on all of the remaining liability issues in the case. Teva
and Sandoz had already conceded infringement and the validity of
AstraZeneca's patent. Thus, only the inequitable conduct contentions
remained to be resolved. The Court had previously set a date for trial
beginning on August 11, 2008.
Important Safety Information for SEROQUEL
SEROQUEL is indicated for the treatment of depressive episodes in
bipolar disorder; acute manic episodes in bipolar I disorder, as either
monotherapy or adjunct therapy to lithium or divalproex; for the
maintenance treatment of bipolar I disorder as adjunct therapy to lithium
or divalproex; and schizophrenia. Patients should be periodically
reassessed to determine the need for continued treatment and the
appropriate dose.
Elderly patients with dementia-related psychosis treated with atypical
antipsychotic drugs are at an increased risk (1.6 to 1.7 times) of death,
compared to placebo (4.5% vs 2.6%, respectively). SEROQUEL is not approved
for the treatment of patients with dementia-related psychosis. (See Boxed
Warning.)
Antidepressants increased the risk of suicidal thinking and behavior in
children, adolescents, and young adults in short-term studies of major
depressive disorder and other psychiatric disorders. Patients of all ages
started on therapy should be observed closely for clinical worsening,
suicidality, or unusual changes in behavior. Families and caregivers should
be advised of the need for close observation and communication with the
prescriber. SEROQUEL is not approved for use in patients under the age of
18 years. (See Boxed Warning.)
Hyperglycemia, in some cases extreme and associated with ketoacidosis,
hyperosmolar coma, or death, has been reported in patients treated with
atypical antipsychotics, including SEROQUEL. The relationship of atypical
use and glucose abnormalities is complicated by the possibility of
increased risk of diabetes in the schizophrenic population and the
increasing incidence of diabetes in the general population. However,
epidemiological studies suggest an increased risk of treatment-emergent,
hyperglycemia-related adverse reactions in patients treated with atypical
antipsychotics. Patients starting treatment with atypical antipsychotics
who have or are at risk for diabetes should undergo fasting blood glucose
testing at the beginning of and periodically during treatment. Patients who
develop symptoms of hyperglycemia should also undergo fasting blood glucose
testing.
A potentially fatal symptom complex, sometimes referred to as
Neuroleptic Malignant Syndrome (NMS), has been reported in association with
administration of antipsychotic drugs, including SEROQUEL. Rare cases of
NMS have been reported with SEROQUEL. Clinical manifestations of NMS are
hyperpyrexia, muscle rigidity, altered mental status, and evidence of
autonomic instability (irregular pulse or blood pressure, tachycardia,
diaphoresis, and cardiac dysrhythmia). Additional signs may include
elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute
renal failure. The management of NMS should include immediate
discontinuation of antipsychotic drugs.
Leukopenia, neutropenia, and agranulocytosis (including fatal cases),
have been reported temporally related to atypical antipsychotics, including
SEROQUEL. Patients with a pre-existing low white blood cell (WBC) count or
a history of drug induced leukopenia/neutropenia should have their complete
blood count monitored frequently during the first few months of therapy. In
these patients, SEROQUEL should be discontinued at the first sign of a
decline in WBC absent other causative factors. Patients with neutropenia
should be carefully monitored, and SEROQUEL should be discontinued in any
patient if the absolute neutrophil count is < 1000/mm3.
Tardive dyskinesia (TD), a potentially irreversible syndrome of
involuntary dyskinetic movements, may develop in patients treated with
antipsychotic drugs. The risk of developing TD and the likelihood that it
will become irreversible are believed to increase as the duration of
treatment and total cumulative dose of antipsychotic drugs administered to
the patient increase. TD may remit, partially or completely, if
antipsychotic treatment is withdrawn. SEROQUEL should be prescribed in a
manner that is most likely to minimize the occurrence of TD.
Warnings and Precautions also include the risk of orthostatic
hypotension, cataracts, seizures, hyperlipidemia, and possibility of
suicide attempts. Examination of the lens by methods adequate to detect
cataract formation, such as slit lamp exam or other appropriately sensitive
methods, is recommended at initiation of treatment or shortly thereafter,
and at 6-month intervals during chronic treatment. The possibility of a
suicide attempt is inherent in schizophrenia, and close supervision of high
risk patients should accompany drug therapy.
The most commonly observed adverse reactions associated with the use of
SEROQUEL versus placebo in clinical trials for schizophrenia and bipolar
disorder were dry mouth (9%-44% vs 3%-13%), sedation (30% vs 8%),
somnolence (18%-34% vs 7%-9%), dizziness (9%-18% vs 5%-7%), constipation
(8%-10% vs 3%- 5%), asthenia (5%-10% vs 3%-4%), abdominal pain (4%-7% vs
1%-3%), postural hypotension (4%-7% vs 1%-2%), pharyngitis (4%-6% vs 3%),
weight gain (5%-6% vs 1%-3%), lethargy (5% vs 2%), nasal congestion (5% vs
3%), SGPT increased (5% vs 1%), and dyspepsia (5%-7% vs 1%-4%).
In long-term clinical trials of quetiapine, hyperglycemia (fasting
glucose greater than or equal to 126 mg/dL) was observed in 10.7% of
patients receiving quetiapine (mean exposure 213 days) vs 4.6% in patients
receiving placebo (mean exposure 152 days).
Please see Prescribing Information, including Boxed Warnings for
SEROQUEL.
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the
research, development, manufacturing and marketing of meaningful
prescription medicines and supplier for healthcare services. AstraZeneca is
one of the world's leading pharmaceutical companies with healthcare sales
of $29.55 billion and is a leader in gastrointestinal, cardiovascular,
neuroscience, respiratory, oncology and infectious disease medicines. In
the United States, AstraZeneca is a $13.35 billion dollar healthcare
business with 12,200 employees committed to improving people's lives.
AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as
well as the FTSE4Good Index.
For more information visit http://www.astrazeneca-us.com.
The statements contain herein include forward-looking statements.
Although we believe our expectations are based on reasonable assumptions,
any forward-looking statements, by their very nature, involve risks and
uncertainties and may be influenced by factors that could cause actual
outcomes and results to be materially different from those predicted. The
forward-looking statements reflect knowledge and information available at
the date of the preparation of this press release and the Company
undertakes no obligation to update these forward-looking statements.
Important factors that could cause actual results to differ materially from
those contained in forward-looking statements, certain of which are beyond
our control, include, among other things, those risk factors identified in
the Company's Annual Report/Form 20-F for 2007. Nothing contained herein
should be construed as a profit forecast.
SOURCE AstraZeneca
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Related links:
http://www.astrazeneca-us.com
http://www.prnewswire.com/comp/985887.html/
CONTACT:
Jim Minnick, +1-302-886-5135,
Jim.Minnick@astrazeneca.com, or Tony Jewell, +1-302-897-2638,
Tony.Jewell@astrazeneca.com, both of AstraZeneca
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