Thursday, 29 September 2011
AstraZeneca (NYSE: AZN) today announced it has entered into a settlement agreement in its U.S. SEROQUEL XR® patent infringement litigation against Handa Pharmaceuticals, LLC ("Handa") regarding Handa’s proposed generic version of AstraZeneca’s SEROQUEL XR (quetiapine fumarate) extended-release tablets.
The agreement settles the patent infringement litigation filed by AstraZeneca following Handa’s submission to the U.S. Food and Drug Administration of an Abbreviated New Drug Application (ANDA) for a generic version of SEROQUEL XR. Under the settlement agreement, Handa does not dispute that both patents asserted by AstraZeneca in the U.S. patent litigation are valid and enforceable.
As part of the agreement, AstraZeneca has granted Handa a license to enter the U.S. market with generic SEROQUEL XR on 1 November 2016 or earlier upon certain circumstances. SEROQUEL XR is protected by patents and other exclusivity rights that range from March 2012 to November 2017.
AstraZeneca and Handa will file a proposed Consent Judgment with the U.S. District Court for the District of New Jersey requesting the Court dismiss the pending legal action between AstraZeneca and Handa. The remaining SEROQUEL XR patent infringement litigations remain on-going.
“We believe this agreement reaffirms our intellectual property rights and is the right business decision for AstraZeneca at this time. SEROQUEL XR remains an important part of our company’s portfolio benefiting patients and physicians throughout the world,” said David Brennan, CEO of AstraZeneca.
This settlement will have no impact on the Company’s full year 2011 financial guidance. As is customary, the Company will review its financial guidance in conjunction with its Third quarter and Nine Months 2011 Financial Results announcement on 27 October.
About SEROQUEL XR
SEROQUEL XR, a once-daily, extended-release tablet formulation of quetiapine fumarate, is approved in the US in adults for (1) add-on treatment to an antidepressant for patients with major depressive disorder (MDD) who did not have an adequate response to antidepressant therapy; (2) acute depressive episodes in bipolar disorder; (3) acute manic or mixed episodes in bipolar disorder alone or with lithium or divalproex; (4) long-term treatment of bipolar disorder with lithium or divalproex; and (5) schizophrenia.
Important Safety Information for SEROQUEL XR
- Elderly patients with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) treated with this type of medicine are at an increased risk of death, compared to placebo (sugar pill). Seroquel XR is not approved for treating these patients.
- Antidepressants have increased the risk of suicidal thoughts and actions in some children, teenagers, and young adults. Patients of all ages starting treatment should be watched closely for worsening of depression, suicidal thoughts or actions, unusual changes in behavior, agitation, and irritability. Patients, families, and caregivers should pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. Report any change in these symptoms immediately to the doctor. Seroquel XR is not approved for patients under the age of 18 years
- Stop Seroquel XR and call your doctor right away if you have some or all of the following symptoms: high fever; stiff muscles; confusion; sweating; changes in pulse, heart rate, and blood pressure. These may be symptoms of neuroleptic malignant syndrome (NMS), a rare and serious condition that can lead to death
- High blood sugar and diabetes have been reported with Seroquel XR and medicines like it. If you have diabetes or risk factors such as obesity or a family history of diabetes, your doctor should check your blood sugar before you start taking Seroquel XR and also during therapy. If you develop symptoms of high blood sugar or diabetes, such as excessive thirst or hunger, increased urination, or weakness, contact your doctor. Complications from diabetes can be serious and even life threatening
- Increases in triglycerides and in LDL (bad) cholesterol and decreases in HDL (good) cholesterol have been reported with Seroquel XR. Your doctor should check your cholesterol levels before you start Seroquel XR and during therapy
- Weight gain has been reported with Seroquel XR. Your doctor should check your weight regularly
- Tell your doctor about any movements you cannot control in your face, tongue, or other body parts, as they may be signs of a serious condition called tardive dyskinesia (TD). TD may not go away, even if you stop taking Seroquel XR. TD may also start after you stop taking Seroquel XR
- Other risks include feeling dizzy or lightheaded upon standing, decreases in white blood cells (which can be fatal), or trouble swallowing. Tell your doctor if you experience any of these
- Before starting treatment, tell your doctor about all prescription and nonprescription medicines you are taking. Also tell your doctor if you have or have had low white blood cell count, seizures, abnormal thyroid tests, high prolactin levels, heart or liver problems, or cataracts. An eye exam for cataracts is recommended at the beginning of treatment and every 6 months thereafter
- Since drowsiness has been reported with Seroquel XR, you should not participate in activities such as driving or operating machinery until you know that you can do so safely. Avoid becoming overheated or dehydrated while taking Seroquel XR. Do not drink alcohol while taking Seroquel XR
- Tell your doctor if you are pregnant or intend to become pregnant. Avoid breast-feeding while taking Seroquel XR
- The most common side effects are drowsiness, dry mouth, constipation, dizziness, increased appetite, upset stomach, weight gain, fatigue, disturbance in speech and language, and stuffy nose
- Do not stop taking Seroquel XR without talking to your doctor. Stopping Seroquel XR suddenly may cause side effects
- This is not a complete summary of safety information. You should discuss the full Prescribing Information with your health care provider
SEROQUEL XR is a registered trademark of the AstraZeneca group of companies.
NOTE TO EDITORS:
On 13 December, 2010 Handa announced that its ANDA, seeking approval for generic copies of SEROQUEL XR, had received tentative approval from the U.S. FDA. Handa further announced that they believed they are the first applicant to file for 50, 150, 200 and 300mg tablets and, that they will be entitled to 180 days of marketing exclusivity for these tablet strengths upon receipt of final regulatory approval.
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.
For more information about AstraZeneca in the U.S. or our AZ&Me™ Prescription Savings programs, please visit: www.astrazeneca-us.com or call 1-800-AZandMe (292-6363).
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