Followers | 443 |
Posts | 63457 |
Boards Moderated | 1 |
Alias Born | 04/26/2007 |
Thursday, September 29, 2011 8:28:12 PM
Astrazeneca (NYSE:AZN)
Today : 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
For further information on SEROQUEL XR, please see the Full Prescribing Information, including Boxed Warnings and Medication Guide.
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.
About AstraZeneca
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).
Please research all stocks before investing. My posts are my opinions and are not buy or sell recommendations. Always force abusive short sellers to cover above what you paid. Build wealth for fellow iHub'ers!
Recent AZN News
- Arm Sets 2025 Target for AI Chip Development, Amazon and Microsoft Commit Billions to French Investments, and More • IH Market News • 05/13/2024 11:16:03 AM
- Cellectis Announces Completion of the Additional Equity Investment by AstraZeneca • GlobeNewswire Inc. • 05/06/2024 06:00:00 AM
- CALQUENCE combination regimen demonstrated statistically significant and clinically meaningful improvement in progression-free survival in 1st-line mantle cell lymphoma in ECHO Phase III trial • Business Wire • 05/02/2024 11:00:00 AM
- AstraZeneca unveils latest research across key respiratory and immune-mediated diseases at ATS 2024 showcasing strength of its broad pipeline and portfolio • Business Wire • 05/01/2024 11:05:00 AM
- ENHERTU® (fam-trastuzumab deruxtecan-nxki) improved PFS in HER2-low and ultralow • Business Wire • 04/29/2024 11:00:00 AM
- AbelZeta Announces Abstract for C-CAR031 Accepted for Presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting • PR Newswire (US) • 04/25/2024 12:00:00 PM
- U.S. Futures Drop in Pre-Market Trading as Tech Stocks Plunge After Meta Issues Gloomy Forecast • IH Market News • 04/25/2024 11:53:54 AM
- Southwest Shares Tumble 9.6% Post $231 Million 1Q Loss, AstraZeneca Surges on 19% Annual Increase, and More on Earnings • IH Market News • 04/25/2024 11:52:46 AM
- Q1 2024 results • Business Wire • 04/25/2024 06:00:00 AM
- IMFINZI® (durvalumab) plus chemotherapy doubled overall survival rate at three years for patients with advanced biliary tract cancer in TOPAZ-1 Phase III trial • Business Wire • 04/16/2024 11:00:00 AM
- Paramount Global Board Shrinks, Morgan Stanley Faces Regulatory Probe, and More News • IH Market News • 04/12/2024 11:05:29 AM
- Costco Increases Dividend by 14%, Meta Introduces ‘Artemis’ AI Chip, and More News • IH Market News • 04/11/2024 11:24:54 AM
- FASENRA approved for treatment of children aged 6 to 11 with severe asthma • Business Wire • 04/11/2024 11:00:00 AM
- ENHERTU® Approved in the U.S. as First Tumor Agnostic HER2 Directed Therapy for Previously Treated Patients with Metastatic HER2 Positive Solid Tumors • Business Wire • 04/06/2024 03:10:00 AM
- ENHERTU® (fam-trastuzumab deruxtecan-nxki) approved in the US as first tumor-agnostic HER2-directed therapy for previously treated patients with metastatic HER2-positive solid tumors • Business Wire • 04/06/2024 01:43:00 AM
- IMFINZI® (durvalumab) significantly improved overall survival and progression-free survival for patients with limited-stage small cell lung cancer in ADRIATIC Phase III trial • Business Wire • 04/05/2024 11:00:00 AM
- Datopotamab deruxtecan Biologics License Application accepted in the US for patients with previously treated metastatic HR-positive, HER2-negative breast cancer • Business Wire • 04/02/2024 11:00:00 AM
- Datopotamab Deruxtecan Biologics License Application Accepted in the U.S. for Patients with Previously Treated Metastatic HR Positive, HER2 Negative Breast Cancer • Business Wire • 04/02/2024 06:00:00 AM
- VOYDEYA™ approved in the US as add-on therapy to ravulizumab or eculizumab for treatment of extravascular hemolysis in adults with the rare disease PNH • Business Wire • 04/01/2024 11:00:00 AM
- GameStop Shares Tumble 20% in Pre-Market Trading Amid Revenue Decline, Direct Digital Plummets 42%, and More News • IH Market News • 03/27/2024 10:54:47 AM
- Super Micro Computer and Seagate Shares Surge on Analyst Optimism in Pre-Market Trading, and Latest News • IH Market News • 03/26/2024 11:20:49 AM
- ULTOMIRIS® (ravulizumab-cwvz) approved in the US for the treatment of adults with neuromyelitis optica spectrum disorder (NMOSD) • Business Wire • 03/25/2024 11:00:00 AM
- Unilever Initiates Ice Cream Division Spin-Off and Announces Job Cuts; Berkshire Ramps Up Share Buyback Efforts, and More • IH Market News • 03/19/2024 11:33:10 AM
- AstraZeneca to acquire Fusion to accelerate the development of next-generation radioconjugates to treat cancer • Business Wire • 03/19/2024 11:00:00 AM
- AstraZeneca to acquire Fusion for $2 billion • IH Market News • 03/19/2024 10:52:44 AM
Avant Technologies Equipping AI-Managed Data Center with High Performance Computing Systems • AVAI • May 10, 2024 8:00 AM
VAYK Discloses Strategic Conversation on Potential Acquisition of $4 Million Home Service Business • VAYK • May 9, 2024 9:00 AM
Bantec's Howco Awarded $4.19 Million Dollar U.S. Department of Defense Contract • BANT • May 8, 2024 10:00 AM
Element79 Gold Corp Successfully Closes Maverick Springs Option Agreement • ELEM • May 8, 2024 9:05 AM
Kona Gold Beverages, Inc. Achieves April Revenues Exceeding $586,000 • KGKG • May 8, 2024 8:30 AM
Epazz plans to spin off Galaxy Batteries Inc. • EPAZ • May 8, 2024 7:05 AM