US Court of Appeals affirms Summary Judgment decision in SEROQUEL® patent litigation

September 25, 2009 – Wilmington, DE – AstraZeneca (NYSE: AZN) today announced that the US Court of Appeals for the Federal Circuit has affirmed the Summary Judgment decision of No Inequitable Conduct in patent litigation involving SEROQUEL® (quetiapine fumarate) tablets.   In July 2008, AstraZeneca announced that the US District Court for the District of New Jersey granted the company's Motion for Summary Judgment of No Inequitable Conduct in litigation involving Teva Pharmaceutical Industries Ltd. and Sandoz, Inc.  

This most recent decision upholds the District Court’s judgment that Teva’s and Sandoz’s products will infringe AstraZeneca’s SEROQUEL patent and that the patent is valid and enforceable. 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). Teva and Sandoz had conceded infringement and the validity of AstraZeneca’s patent covering SEROQUEL. The ANDAs sought approval to market generic versions of SEROQUEL tablets in the US before SEROQUEL’s patent expires.  The patent covering SEROQUEL expires in September 2011, with pediatric exclusivity through March 2012.  

Since the Federal Circuit Court of Appeals’ affirmed Summary Judgment in favor of AstraZeneca, trial remains unnecessary.

About SEROQUEL
SEROQUEL was first approved in the US in 1997 and is currently approved in adults 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 for the treatment of schizophrenia in adult patients. The safety of SEROQUEL has been evaluated in clinical trials with thousands of adult patients and continues to be reviewed by the FDA.

Indications 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 in adult patients. Patients should be periodically reassessed to determine the need for continued treatment and the appropriate dose.  

Important Safety Information for SEROQUEL

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.

In long-term clinical trials of quetiapine, hyperglycemia (fasting glucose > 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).

Clinically significant increases in cholesterol (7%-16% for quetiapine vs. 3%-9% for placebo) and triglycerides (8%-23% for quetiapine vs. 5%-16% for placebo) have been observed in clinical trials.

The proportion of patients in clinical trials meeting a weight gain criterion of ≥ 7% of body weight was 5%-23% for quetiapine vs. 0%-7% for placebo.    

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, hyperprolactinemia, 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 reported adverse reactions associated with the use of SEROQUEL vs. placebo in clinical trials for schizophrenia and bipolar disorder were somnolence (18%-57% vs. 8%-15%), dry mouth (9%-44% vs. 3%-13%), 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%).  

Please see Prescribing Information, including Boxed Warnings for SEROQUEL.

About AstraZeneca
AstraZeneca is engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and in the supply of healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with global healthcare sales of $ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines.  In the United States, AstraZeneca is a $13.5 billion dollar healthcare business.  

For more information about AstraZeneca in the US or our AZ&Me™ Prescription Savings programs, please visit: www.astrazeneca-us.com.

Media Contacts: 

• Kirsten Evraire, AstraZeneca: 302-885-0435
• Abigail Baron, AstraZeneca: 302-885-3578

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