U.S. Court Of Appeals Upholds AstraZeneca PLC's AWP Settlement
November 21, 2009 |
| AstraZeneca PLC announced that the United States Court of Appeals for the First Circuit upheld an earlier District Court ruling on November 19, 2009, approving a settlement in the long-running Average Wholesale Price (AWP) pharmaceutical litigation against AstraZeneca Pharmaceuticals. The ruling affirms a settlement that awarded consumers who purchased the pharmaceutical giant's prostate cancer drug Zoladex treble damages, a rare if not unprecedented event in consumer litigation. The case, argued by Steve W. Berman a Seattle plaintiff's attorney with Hagens Berman Sobol Shapiro (HBSS), afforded thousands of consumers access to a $24 million settlement against the drug giant accused of manipulating the price of Zoladex. Under the settlement approved by the U.S. District Court in November 2007, any consumer who could provide reasonable documentation can receive three times the actual damages. Any funds left over from the $24 million settlement would go to non-profit organizations. Experts representing the plaintiffs expect that only about $21 million will be claimed by class members, many of whom have passed away since the case was filed. The ruling was in response to an appeal filed by a class member who objected to the settlement, claiming the cy pre fund lowered the amount of recovery to class members. |
AstraZeneca PLC Submits US New Drug Application For Ticagrelor (BRILINTA)
November 19, 2009 |
| AstraZeneca PLC announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ticagrelor, an investigational oral antiplatelet treatment for the reduction of major adverse cardiac events in patients with acute coronary syndrome (ACS). The proposed trade name for ticagrelor is BRILINTA, pending approval from the FDA. This submission is based on the results of a comprehensive program, including data from PLATO (A Study of Platelet Inhibition and Patient Outcomes), the Phase III head-to-head trial comparing ticagrelor plus aspirin with clopidogrel (Plavix) plus aspirin. |
AstraZeneca PLC Announces Results From Two Phase II Trials Add To Understanding Of Ticagrelor (BRILINTA) And How It Works In The Body
November 18, 2009 |
| AstraZeneca PLC announced the results of the phase II studies, ONSET/OFFSET and RESPOND for ticagrelor (BRILINTA) at the annual American Heart Association (AHA) Scientific Sessions in Orlando, FL, with ONSET/OFFSET study results being simultaneously published in the medical journal Circulation. The ONSET/OFFSET data showed that treatment with ticagrelor (BRILINTA) achieved a more rapid onset of antiplatelet effect (41% IPA vs. 8% at 30 minutes; P<0.0001), greater inhibition of platelet aggregation (IPA) that was sustained during maintenance phase of treatment (IPA; P<0.0001 at all times) and faster offset IPA compared to clopidogrel, in patients with stable coronary artery disease (CAD) on aspirin therapy. Platelets initiate the formation of blood clots by sticking together (clumping or aggregating), a process called platelet aggregation. Inhibition of platelet aggregation (IPA) is the prevention of clumping of platelets in the blood, which reduces the risk of clot formation and subsequent thrombotic events. These results were achieved using ticagrelor 180 mg loading dose followed by 90 mg twice daily, as studied in PLATO (A Study of Platelet Inhibition and Patient Outcomes), compared to clopidogrel 600 mg loading dose followed by 75 mg once daily dose. |
Proposed AstraZeneca PLC Anticlotting Drug Better Than Plavix-DJ
November 15, 2009 |
| Dow Jones reported that An experimental anticlotting drug being developed by AstraZeneca PLC was more effective than the widely used Plavix when used before and after a procedure to open a blocked coronary artery in patients suffering a heart attack, according a new analysis scheduled to be released Sunday. The drug, with a generic name of ticagrelor, like Plavix is designed to keep blood platelets from sticking together in order to prevent blood clots that can lead to heart attacks and strokes. AstraZeneca plans to file an application seeking U.S. Food and Drug Administration approval of ticagrelor by the end of this year. The Company has proposed a brand name of Brilinta. The FDA typically takes at least 10 months to approve a drug so it likely wouldn't be on the market for about year assuming there are no delays in the approval process. In August results were released from a study involving 18,624 patients with heart problems, which showed ticagrelor reduced the combination of heart attacks, strokes and death from cardiovascular causes by 16% compared with Plavix after being treated for a year. All patients received aspirin. The study was funded by AstraZeneca. Now additional data looking at a group of patients considered to have had a severe heart attack are scheduled to be presented Sunday at the American Heart Association's annual meeting in Orlando, Fla. |
Arnold & Itkin Announces Lawsuit Against AstraZeneca PLC And Others Over Defective Pain Pumps
November 11, 2009 |
| The law firm Arnold & Itkin LLP has filed five lawsuits against the makers of pain pumps and related medications based on claims that many of the companies' defective devices are causing irreversible shoulder damage among patients. Currently, the attorneys at Arnold & Itkin are representing 28 people who received pain pumps to manage pain following shoulder surgery. According to the lawsuits, pain pump manufacturers were denied approval by the U.S. Food and Drug Administration to use the pumps to mitigate pain in shoulder joints, but the companies continued to promote their use in that way. Many former pain pump users say the companies were negligent in designing, researching and selling pain pumps that they should have known were dangerous. The legal filings include claims of fraud, breach of warranty and products liability against the defendant manufacturers. Plaintiffs allege that the pain pumps cause postarthroscopic glenohumeral chondrolysis (PAGCL), the progressive destruction of cartilage in the glenohumeral joint connecting the arm to the shoulder. Without the cartilage, bones grind together causing excruciating pain. Named as defendants are several pain pump manufacturers, including Stryker Corporation, Orthofix International N.V., I-Flow Corporation, Moog Inc., Sgarlato R.P. Inc., Breg Inc., Linvatec Corp., and DJO Inc. The lawsuits also name several pharmaceutical companies, including AstraZeneca PLC, Abbott Laboratories, APP Pharmaceuticals and Hospira, Inc. |
EU Panel Says AstraZeneca PLC Pulls Mkting Authorization For Zactima-DJ
October 30, 2009 |
| Dow Jones reported that the European Medicines Agency said that it has been formally notified by AstraZeneca PLC of its decision to withdraw its application for a centralized marketing authorization for the medicine Zactima (vandetinib), 100 mg film-coated tablets. Zactima was expected to be used in combination with chemotherapy, for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received prior anticancer therapy. The application for the marketing authorization for Zactima was submitted to the Agency on 30 June. At the time of the withdrawal, it was under review by the Agency's Committee for Medicinal Products for Human Use (CHMP). In its official letter, AstraZeneca PLC stated that the withdrawal of the application was based on the preliminary comments from the Rapporteur and Co-Rapporteur, which indicate that at this point in time the Committee would be unlikely to conclude on a favourable benefit-risk balance for the product in the treatment of NSCLC in combination with chemotherapy. |
AstraZeneca PLC In $520 Million Pact To Resolve Seroquel Probe-DJ
October 29, 2009 |
| Dow Jones reported that AstraZeneca PLC said that it has reached a $520 million agreement in principle to settle a U.S. investigation into the Company's marketing of schizophrenia drug Seroquel. The U.S. Attorney's Office in Philadelphia has been leading an investigation into the Company's marketing of Seroquel, including allegations that the Company promoted the drug for uses for which it is not approved by the Food and Drug Administration. The Company has reached the agreement in principle in September to resolve the investigations for $520 million, subject to the negotiation and finalization of appropriate implementing agreements, including civil settlement agreements and a corporate integrity agreement. |
AstraZeneca PLC Raises FY 2009 Outlook-Conference Call
October 29, 2009 |
| AstraZeneca PLC announced that for fiscal 2009, it now expects revenue to grow in mid-to-high single digits on constant-currency basis and core earnings per share (EPS) to be $6.20-6.40. The Company reported revenue of $31.601 billion for fiscal 2008. According to Reuters Estimates, analysts on an average were expecting the Company to report EPS of $5.99 on revenue of $32.171 billion for fiscal 2009. |
AstraZeneca PLC Withdraws Regulatory Submissions For Zactima (Vandetanib) In Combination With Chemotherapy For Advanced NSCLC
October 28, 2009 |
| AstraZeneca PLC announced that it has withdrawn the regulatory submissions for the use of ZACTIMA (vandetanib) 100mg in combination with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) from the US FDA and the European Medicines Agency (EMEA). The applications were submitted to regulatory agencies in June 2009. The decision to withdraw these submissions was based on an updated analysis that demonstrated no overall survival advantage when vandetanib was added to chemotherapy as well as preliminary feedback from regulatory agencies that the current package with progression-free survival (PFS) as the primary endpoint may not be sufficient for approval. Phase III clinical trial results demonstrate that vandetanib is clinically active when used in combination with chemotherapy. AstraZeneca will complete the ongoing Phase III trial programme which will give a more complete view of vandetanib efficacy in different clinical settings. Results from the ZEPHYR (300mg monotherapy study in patients with advanced NSCLC who have previously received an EGFR inhibitor) and ZETA (300 mg monotherapy in advanced medullary thyroid cancer) studies are expected in late 2009 or early 2010. |
Nektar Therapeutics And AstraZeneca PLC Announce Phase 2 Data From Oral NKTR-118
October 27, 2009 |
| Nektar Therapeutics and AstraZeneca PLC announced data from a phase II study that demonstrated oral NKTR-118 improved lower gastrointestinal dysfunction by increasing the frequency of bowel movements in patients with opioid-induced constipation, while simultaneously preserving opioid-mediated analgesia. NKTR-118, an oral peripherally-acting opioid antagonist, is an investigational product candidate in clinical development for the treatment of opioid-induced constipation. In the phase II double blind, randomized, placebo-controlled study of 208 patients with opioid-induced constipation, NKTR-118 achieved the primary endpoint of change from baseline in spontaneous bowel movements (SBMs). Patients receiving either 25 mg or 50 mg of oral NKTR-118 once daily had a significantly greater change from baseline in SBMs during the first week of treatment than patients receiving placebo. The mean change from baseline in SBMs per week for patients receiving 25 mg NKTR-118 was 3.6 versus 1.9 in the placebo group (p= 0.002). Patients receiving 50 mg NKTR-118 had a mean change from baseline in SBMs per week of 4.4 versus 1.9 in the placebo group (p=0.0001). The increase from baseline in SBMs versus placebo averaged over the four-week treatment period was significant for both the 25 mg (p=0.002) and 50 mg (p<0.0001) dose groups. Results for the 5 mg dose of NKTR-118 were not significant. |
Interim Clinical Trial Results Show AstraZeneca PLC's MedImmune's H1N1 Vaccine Has Similar Safety Profile As Seasonal Vaccine In Eligible Children And Adults
October 22, 2009 |
| AstraZeneca PLC's MedImmune announced that interim data from human studies of its nasal spray vaccine for the 2009 Influenza A (H1N1) virus demonstrate a similar clinical profile in children and adults 2 to 49 years of age as previously studied seasonal formulations of the vaccine. The live attenuated influenza vaccine (LAIV) for the 2009 Influenza A (H1N1) virus received approval from the U.S. Food and Drug Administration (FDA) on September 15, 2009. Two randomized, double-blind, placebo-controlled trials are ongoing in children (2-17 years) and adults (18-49 years) to evaluate the safety, tolerability, and immunogenicity of vaccine. A total of 326 children and 300 adults were randomly assigned to receive 2 doses of 2009 H1N1 LAIV or placebo 28 days apart. Both clinical trials are collecting data following a second dose of the vaccine. LAIV for 2009 H1N1 is made using the same process as LAIV for seasonal influenza. The safety of the 2009 H1N1 vaccine was evaluated in the same way that the safety of new seasonal LAIV strains is assessed every year. The H1N1 vaccine was also evaluated in children to further establish its safety profile. In children, the most common side effects following the first dose of vaccine included headache, runny/stuffy nose, and cough. In adults, the most common side effects were headache, runny nose and decreased activity. Symptoms after the second dose were similar but generally occurred at lower rates in both children and adults. |
AstraZeneca PLC Cutting US Sales Force, Asking Reps To Volunteer For Buyouts-AP
October 19, 2009 |
| The Associated Press reported that AstraZeneca PLC plans to cut its U.S. sales force by offering buyouts. The Company is asking interested sales representatives to identify themselves. The Company last week notified its approximately 5,500 U.S. sales representatives. The Company isn't saying how many jobs will be cut. |
U.S. Food and Drug Administration Approves AstraZeneca PLC's CRESTOR For Use In Pediatric Patients With Heterozygous Familial Hypercholesterolemia
October 16, 2009 |
| AstraZeneca PLC announced that U.S. Food and Drug Administration (FDA) approved CRESTOR (rosuvastatin calcium) for use in pediatric patients ages 10-17 with heterozygous familial hypercholesterolemia (HeFH) when diet therapy fails to reduce elevated cholesterol. HeFH, a genetic disease, is characterized by high LDL cholesterol (the bad cholesterol) and increased risk of early cardiovascular disease. The FDA decision was based on a supplemental New Drug Application submitted by AstraZeneca which included data from the PLUTO (Pediatric Lipid-redUction Trial of rOsuvastatin) study. PLUTO was designed to evaluate the efficacy and safety of CRESTOR in children ages 10-17 with HeFH. |
AstraZeneca PLC And POZEN Inc. Submit EU Marketing Application For Vimovo-DJ
October 16, 2009 |
| Dow Jones reported that AstraZeneca PLC said that it and POZEN Inc. have submitted a marketing authorization application in the European Union via the decentralised procedure for Vimovo tablets. |
Kentucky Jury Announces $14.7 Million Verdict Against AstraZeneca PLC-AP
October 15, 2009 |
| The Associated Press reported that a Kentucky jury has hit AstraZeneca PLC with a $14.7 million verdict in a case that claimed the Company inflated its prescription drug prices for Medicaid reimbursements. The Medicaid program calculates its drug reimbursement rates based on published average wholesale prices. Prosecutors claimed AstraZeneca PLC inflated those published prices. AstraZeneca PLC believes the claims are unfounded and is looking at options, including appeal. The Alabama Supreme Court is considering an appeal of a verdict against the Company in another Medicaid inflated drug-pricing fraud lawsuit. |
AstraZeneca PLC And Bristol-Myers Squibb Co. Announce Results Of ONGLYZA When Added To Metformin And When Added To Metformin In Reducing Hemoglobin (HbA1c) In Adults With Type 2 Diabetes Mellitus
October 5, 2009 |
| AstraZeneca PLC and Bristol-Myers Squibb Co. announced that results from an 18-week phase 3b study in adults with type 2 diabetes with inadequate glycemic control on metformin therapy alone found that the addition of treatment with ONGLYZA (saxagliptin) 5 mg per day achieved the primary objective of demonstrating non-inferiority compared to the addition of treatment with JANUVIA (sitagliptin) 100 mg per day in reducing HbA1c from baseline. In this study, overall adverse events were reported at a similar rate for individuals taking ONGLYZA 5 mg plus metformin and JANUVIA 100 mg plus metformin. This study was submitted to the European Medicines Agency (EMEA) as part of the Marketing Authorization Application for ONGLYZA. Complete findings from this study will be submitted for publication in the first half of 2010. In the primary analysis of individuals who completed the study and complied with study procedures, ONGLYZA 5 mg per day achieved an adjusted mean change from baseline in HbA1c of -0.52%, compared to -0.62% for subjects taking JANUVIA 100 mg per day. Results of the study demonstrated that therapy with ONGLYZA 5 mg was non-inferior to JANUVIA 100 mg when added to metformin (difference in adjusted mean change from baseline vs. JANUVIA plus metformin 0.09%, 95% CI -0.01 to 0.20). Non-inferiority of ONGLYZA to JANUVIA was also demonstrated in a confirmatory analysis of all individuals receiving study treatment for whom a change from baseline in HbA1c could be calculated. |
AstraZeneca PLC's And Bristol-Myers Squibb Co.'s ONGLYZATM (saxagliptin) Receives Marketing Authorisation In Europe For Treatment Of Type 2 Diabetes
October 5, 2009 |
| Bristol-Myers Squibb Co. and AstraZeneca PLC announced that the European Commission has granted marketing authorisation for ONGLYZATM in the 27 countries of the European Union. ONGLYZA is indicated as a once-daily 5 mg oral tablet dose in adult patients with type 2 diabetes mellitus to improve glycaemic control: in combination with metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control; in combination with a sulphonylurea, when sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate; or in combination with a thiazolidinedione, when the thiazolidinedione alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of a thiazolidinedione is considered appropriate. The launch of ONGLYZA is expected to begin in the fourth quarter of 2009. |
Bristol-Myers Squibb Co. and AstraZeneca PLC Announce European Commission Grant Of Marketing Authorisation For ONGLYZATM In 27 Countries Of European Union
October 5, 2009 |
| Bristol-Myers Squibb Co. and AstraZeneca PLC announced that the European Commission has granted marketing authorisation for ONGLYZATM in the 27 countries of the European Union. ONGLYZA is indicated as a once-daily 5 mg oral tablet dose in adult patients with type 2 diabetes mellitus to improve glycaemic control: in combination with metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control; in combination with a sulphonylurea, when sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate; or in combination with a thiazolidinedione, when the thiazolidinedione alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of a thiazolidinedione is considered appropriate. The marketing authorisation is based on data submitted from a comprehensive clinical development programme that included six core Phase III registrational trials and a Phase IIIB study comparing saxagliptin plus metformin with sitagliptin plus metformin. The registrational trials assessed the safety and efficacy of ONGLYZA and involved 4,148 patients with type 2 diabetes, including 3,021 patients treated with ONGLYZA. The launch of ONGLYZA is expected to begin in the fourth quarter of 2009. |
AstraZeneca PLC And Bristol-Myers Squibb Co. Announce Dapagliflozin Study Demonstrates Improved Glycemic Control And Weight Reduction In Type 2 Diabetes Inadequately Controlled With Metformin
October 2, 2009 |
| AstraZeneca PLC and Bristol-Myers Squibb Co. announced results from a 24-week phase 3 clinical study demonstrated that the investigational drug dapagliflozin, added to metformin, demonstrated significant mean reductions in the primary endpoint, glycosylated hemoglobin level (HbA1c) and in the secondary endpoint, fasting plasma glucose (FPG) in patients with type 2 diabetes inadequately controlled with metformin alone, as compared to placebo plus metformin. Dapagliflozin is a selective, sodium glucose co-transporter 2 (SGLT2) inhibitor, currently in Phase 3 trials under joint development by Bristol-Myers Squibb Co. and AstraZeneca. The study also showed that individuals receiving dapagliflozin had statistically greater mean reductions in body weight compared to individuals taking placebo. After 24 weeks, individuals receiving dapagliflozin 2.5 mg, 5 mg and 10 mg plus metformin demonstrated a statistically significant adjusted mean change in HbA1c from baseline of -0.67%, -0.70% and -0.84%, respectively, compared to -0.30% for placebo (p-value less than 0.0005 for all treatment arms). Individuals treated with dapagliflozin demonstrated a statistically significant adjusted mean change in FPG, a secondary endpoint, from baseline at Week 24: -17.8 mg/dL for dapagliflozin 2.5 mg -21.5 mg/dL for dapagliflozin 5 mg and -23.5 mg/dL /dl for dapagliflozin 10 mg, compared to -6.0 mg/dL for placebo (p-value less than 0.005 for all treatment arms). |
AstraZeneca PLC's Astra Tech Announces Five Year Follow Up Of OsseoSpeed Implant
October 2, 2009 |
| AstraZeneca PLC's Astra Tech announced a five year follow up study was made by Dr. Steveling and co-workers at the Department of Oral and Maxillofacial Surgery at the Heidelberg University in Germany. The conclusion is that the OsseoSpeed implant shows very good results also in compromised sites when using an early loading protocol. Results from the extensive OsseoSpeed clinical study program show good functionality, and predictable and maintained marginal bone levels with a mean marginal bone level reduction of 0.3 mm. The maintained marginal bone levels are also confirmed in prospective studies with three and five year results. There is no significant dip in Implant Stability Quotient values traditionally seen at implants 2-6 weeks after installation. This is interpreted as a continuous gain in osseointegration and stability. Published data shows that the OsseoSpeed implant can be safely used with reported survival rate between 94.5% to 100%, including the use of immediate loading protocol even in the atrophic edentulous maxilla, in sinus lifted maxillary posterior jaw sites, immediate installation in extraction sockets and implants placed in atrophied mandibles close to the nerve. The purpose of the study was to compile and compare data on marginal bone level changes between loading and five years of function for all implant systems currently on the market. |
AstraZeneca PLC's Astra Tech Announces Strategic Alliance with Dental Wings, Inc.
October 1, 2009 |
| AstraZeneca PLC's Astra Tech announced the strategic alliance with Dental Wings, Inc. beginning in early 2010. As a result, Dental Wings users worldwide will have the ability to remotely transfer scans to Astra Tech`s design and manufacturing centers for the production of Atlantis patient-specific abutments for all major implant systems. The process allows scanning of implant cases in the dental laboratory using a Dental Wings 3D scanner. A dedicated interface jointly developed by Astra Tech and Dental Wings facilitates the electronic transfer of scans from the Dental Wings user directly to Astra Tech`s design and manufacturing centers for precise and efficient production of Atlantis abutments |
AstraZeneca PLC Says Seroquel XR, Seroquel Get EU Recognition OK-DJ
September 29, 2009 |
| Dow Jones reported that AstraZeneca PLC said once-daily SereoquelXR (quetiapine fumarate extended-release tablets) and Seroquel (quetiapine fumarate) have been approved under the European Mutual Recognition Procedure for the prevention of recurrence of bipolar disorder in patients whose manic, mixed or depressive episode has responded to quetiapine treatment. AstraZeneca PLC will now move forward with obtaining local approvals with the Member States that take part in the Mutual Recognition Procedure. |
Palatin Technologies, Inc. To Receive $5 Million From AstraZeneca PLC
September 29, 2009 |
| Palatin Technologies, Inc. announced that it will receive $5 million from AstraZeneca PLC relating to an amendment of its ongoing exclusive research collaboration and license agreement to discover, develop and commercialize compounds that target melanocortin receptors for treatment of obesity and related indications. Under the terms of the amendment to the parties' collaboration agreement, AstraZeneca has agreed to make a $2.5 million payment upon signing and, subject to completion of certain tasks relating to the program, $2.5 million in the first quarter of calendar year 2010. Under the amendment, the terms of the original collaboration and license agreement signed in January 2007 relating to milestone payments and royalty rates were restructured. |
UCB Group and AstraZeneca PLC Form Alliance For Commercialization Of Cimzia in Brazil
September 28, 2009 |
| UCB Group and AstraZeneca PLC announced that they have entered into a partnership to register and commercialize UCB's PEGylated anti TNF alpha drug Cimzia (certolizumab pegol) in Brazil. The drug is to be registered for the treatment of rheumatoid arthritis and Crohn's disease. Under the agreement, AstraZeneca will register Cimzia and upon approval will be the exclusive distributor of Cimzia in Brazil. In partnership with UCB, AstraZeneca will have the right to distribute future new line extensions related to Cimzia. UCB retains the right to co promote Cimzia as well as future line extensions in Brazil. This partnership with AstraZeneca will help UCB commercialize its rich pipeline of products and foster the growth of UCB's affiliate in Brazil. |
The First Circuit Of the United States Court Of Appeals Upholds Ruling Of Trial Court In Massachusetts Case Against AstraZeneca PLC
September 24, 2009 |
| AstraZeneca PLC announced that The First Circuit of the United States Court of Appeals upheld an earlier ruling of the trial court in a Massachusetts case against AstraZeneca that concluded the drug giant engaged in unfair and deceptive trade practices by inflating the price of prescription drug Zoladex, clearing the way for a national class-action lawsuit to move forward. The 98-page ruling affirms a judgment of $12.9 million against the Company for violating the Massachusetts Consumer Protection Act. The ruling also clears the way for a national class-action lawsuit originally certified by U.S. District Court Judge Patti Saris on Sept. 29, 2008, which was temporarily stayed until the resolution of AstraZeneca's appeal. The case was originally filed September 2, 2002 and claimed AstraZeneca grossly inflated the price of Zoladex, primarily used to treat prostate cancer, by misstating the Average Wholesale Price (AWP) of these drugs in industry publications. The ruling the court upheld affects patients and insurers who made co-payments and reimbursements for Zoladex from December 1997 to 2003. The original filings claim that the defendants' published AWPs are fictitious because they do not reflect the true average sales price. |
AstraZeneca PLC's Ticagrelor Reduced Cardiovascular Deaths and Heart Attacks In ACS Patients Undergoing Heart Procedures
September 24, 2009 |
| AstraZeneca PLC announced new data from the phase III PLATO study showed that ticagrelor (BRILINTA) provided greater reduction of cardiovascular (CV) events (composite of CV death, heart attack and stroke) than clopidogrel (9.02% vs. 10.65%, p=0.0025 a 16% Relative Risk Reduction ) in acute coronary syndromes patients undergoing planned invasive treatment (either PCI or CABG). Although patients undergoing invasive procedures are at greater risk of bleeding, these results were achieved without a significant increase in major bleeding compared to clopidogrel (11.5% vs 11.6%, p=0.88). Patients with planned invasive procedures at randomization accounted for more than 70% of the greater than 18,000 patients in PLATO. Additional findings from this PLATO invasive sub-analysis showed that treatment with ticagrelor, compared to clopidogrel, demonstrated an effect consistent with the results for the entire invasive subgroup across the multiple secondary efficacy endpoints. The effect was seen regardless of whether a standard 300 mg loading dose of clopidogrel was given, or an additional loading dose of clopidogrel (e.g. 600 mg) was given. |
AstraZeneca PLC And Nektar Therapeutics Signs Worldwide Agreement For Drug Development Programmes
September 21, 2009 |
| AstraZeneca PLC and Nektar Therapeutics announced that they have entered into an exclusive worldwide license agreement for two drug development programmes: NKTR-118, a late stage investigational product being evaluated for the treatment of opioid induced constipation, and the NKTR-119 programme, an early stage programme that is intended to deliver products for the treatment of pain without constipation side effects. Both programmes were developed by Nektar, utilizing their proprietary small molecule advanced polymer conjugate technology platform. Under the terms of the agreement, AstraZeneca will assume the responsibility for the continued development of both the NKTR-118 and NKTR-119 programmes, including the initiation of late-stage clinical studies for NKTR-118. AstraZeneca expects completion of the design of the phase III programme in the near term, and anticipates filing the drug with regulators in 2013. AstraZeneca will also be responsible for global manufacturing and marketing for both programmes. Under the agreement, Nektar will receive an upfront payment of $125 million for both NKTR-118 and NKTR-119. |
U.S. Orders 29 Million Flu Vaccine Doses From AstraZeneca PLC's MedImmune-Reuters
September 21, 2009 |
| Reuters reported that AstraZeneca PLC's MedImmune unit said that the U.S. government has ordered an additional 29 million doses of its H1N1 swine flu vaccine. The vaccine, in nasal spray form, was approved by U.S. health regulators for use in people aged two to 49 against the strain of swine flu that is very easily spread among humans and has been declared a pandemic. |
FDA Approves Four H1N1 Influenza Vaccines Including AstraZeneca PLC's Drug For US-DJ
September 15, 2009 |
| Dow Jones reported that the Food and Drug Administration approved vaccines designed to protect against the H1N1 influenza virus, a key step before starting a vaccination campaign. The approval was announced by Health and Human Services Secretary Kathleen Sebelius at a hearing held by the House Energy and Commerce Committee. An FDA spokeswoman said the agency approved vaccines made by a unit of sanofi-aventis, Novartis AG, CSL Limited and AstraZeneca PLC's MedImmune unit. MedImmune makes a vaccine in the form of mist delivered through the nose rather than a shot. |
PsychoGenics And AstraZeneca PLC Enter Agreement To Identify New Treatments For Central Nervous System Disorders
August 31, 2009 |
| PsychoGenics Inc. and AstraZeneca PLC announced that they have entered into a drug discovery and development agreement to identify compounds that are likely to be useful for the treatment of certain Central Nervous System (CNS) disorders. Under the agreement, PsychoGenics will use its drug discovery technologies to evaluate a number of AstraZeneca drug candidates for their potential to treat psychiatric disorders. PsychoGenics will receive research payments and milestones commensurate with the stage of development, as well as royalties on any future sales. |
AstraZeneca PLC Announces Phase III Head to Head Trial Shows Ticagrelor Reduced Cardiovascular Death and Heart Attacks Over Clopidogrel in Acute Coronary Syndromes Patients
August 30, 2009 |
| AstraZeneca PLC announced results from the phase III head to head trial, PLATO (A Study of Platelet Inhibition and Patient Outcomes), which demonstrate that ticagrelor (BRILINTA) has achieved greater efficacy in the primary endpoint, reduction of cardiovascular events (CV death, MI, stroke) over clopidogrel (Plavix/Iscover) (9.8% vs. 11.7% at 12 months; 16% RRR; 95% CI, 0.77 to 0.92; p < 0.001), without an increase in major bleeding (11.6% vs. 11.2%, p=0.43). This efficacy endpoint was driven by a statistically significant reduction in both CV death (4.0% vs. 5.1%, p=0.001) and heart attacks (myocardial infarction, MI) (5.8% vs. 6.9%, p=0.005) with no difference in stroke (1.5% vs. 1.3%, p=0.22). For patients in the PLATO study, the reduction in risk of cardiovascular events with ticagrelor occurred early and this benefit increased over time compared to clopidogrel. Ticagrelor demonstrated a consistent positive effect across multiple secondary efficacy endpoints including CV death (and separately for all-cause mortality); myocardial infarction; the composite of myocardial infarction, stroke, and all-cause mortality. Among patients who received a stent during the study, a 33% reduction in risk of definite stent thrombosis was achieved with ticagrelor. The PLATO study confirmed the clinical safety profile of previous ticagrelor studies which showed no difference in major bleeding compared to clopidogrel. |
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