The pharmaceutical landscape is rapidly changing as patents for some of the blockbuster drugs of the last decade near expiration and other players try to grab some of the remaining revenues before generic medications flood the market. AstraZeneca (AZN) announced Thursday morning that it has filed a New Drug Application with the FDA for its antiplatelet treatment ticagrelor. The drug is meant to treat major cardiac events in patients with acute coronary syndrome (ACS) a disease that affects 2.4 million Americans according to the American Heart Association.The drug works by keeping platelets in the blood from sticking together which ...
AstraZeneca today announced it has submitted an NDA to the 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. Release
While AstraZeneca preps for its first Seroquel liability trials at the state level, federal lawsuits are coming closer to court as well. U.S. District Judge Anne Conway, who's overseeing pretrial work for thousands of federal Seroquel cases, said she will ask a panel of judges to send all those cases...
Recently, AstraZeneca plc (AZN) announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its blood clot preventer Brilinta (ticagrelor). Brilinta is an oral reversible P2Y12 adenosine diphosphate receptor antagonist for arterial thrombosis aimed to compete with the blockbuster drug Plavix which is co-developed by Bristol-Myers Squibb [...]
This morning, Pozen (POZN) initiated phase III studies on PA-325/40, a fixed-dose combination of 325mg enteric coated aspirin and 40mg of immediate release omeprazole. The phase III program will consist of two pivotal trials conducted under a Special Protocol Assessment (SPA) agreed upon with the U.S. FDA, and one long-term safety study.
The two pivotal programs [...]
This morning, Pozen (POZN) initiated phase III studies on PA-325/40, a fixed-dose combination of 325mg enteric coated aspirin and 40mg of immediate release omeprazole. The phase III program will consist of two pivotal trials conducted under a Special Protocol Assessment (SPA) agreed upon with the U.S. FDA, and one long-term safety study.
The two pivotal programs will enroll approximately 500 patients per study at over 100 sites around the U.S. The primary endpoint of the pivotal studies is the cumulative incidence of gastric ulcers over the six-month treatment period for PA32540 versus 325 mg of enteric-coated aspirin. The long-term study will enroll approximately 400 patients and assess safety over a period of one year.
Pozen is developing PA-325/40 for use in the secondary prevention of heart attacks and strokes in patients at risk for associated gastric ulcers. Aspirin is the No. 1 recommended agent for at-risk patients, with some 50 million Americans take daily aspirin therapy for secondary prevention of heart attacks and strokes.
However, according to data presented at the American College of Gastroenterology and at the American Heart Association meeting, the use of low-dose aspirin for cardiovascular disease prophylaxis is associated with a 2- to 4-fold increase in gastro-intestinal (GI) complications, including gastric ulcers. Enteric coating is not a sufficient to reduce the risk of GI bleeding, and thus the majority of patients that should be taking 325mg aspirin are non-compliant or taking suboptimal low-dose (81mg) "baby" aspirin instead.
Pozen’s PA-325/40 is designed to provide immediate-release omeprazole as a GI-protectant for patients taking full-dose 325mg daily aspirin therapy. If the phase III trials meet the primary endpoint of reduction in cumulative incidence of gastric ulcers, we expect PA-325/40 to be approved by the U.S. FDA with the full cardiovascular label claims of regular enteric-coated aspirin. This is a significant market opportunity in our view, considering less than 15% of the 50 million Americans on daily aspirin therapy are taking a GI-protectant such as omeprazole.
Recently, data from a retrospective analysis of patients that use Sanofi-Aventis (SNY) / Bristol-Myers’ (BMY) Plavix (clopidogrel) showed an increased risk of major adverse cardiovascular events (MACE) by as much as 50% while taking a proton pump inhibitor (PPI) such as AstraZeneca’s (AZN) omeprazole (Prilosec) or esomeprazole (Nexium). The data included analysis of outcomes from 16,700 patients who underwent percutaneous coronary intervention and continued Plavix for 12 months after the procedure.
Approximately 9,900 were not given a PPI at any time during Plavix treatment and 6,800 were given overlapping PPI therapy. The analysis showed a 12-month MACE event rate of about 25% among PPI users, compared with 18% of patients who were not given PPI (MACE hazard ratio of 1.50 for PPI users versus nonusers).
The current Plavix label discourages use of a PPI due to this potential limiting effect on the drug’s effectiveness. The majority of Plavix use for secondary prevention of heart attacks and strokes is with enteric-coated aspirin.
Strengthening this label warning by the U.S. FDA could work to greatly limit the potential uptake for Pozen’s PA-325/40 product. However, we note the retrospective analysis that potentially showed a reduced effectiveness for Plavix while on a PPI was with commercially available delayed release PPIs dosed at the same time as taking Plavix. Pozen is currently conducting a drug-drug interaction study with their immediate release omeprazole doses both at the same time and 12 hours apart from Plavix.
The omeprazole used in PA-325/40 is an immediate release formulation, not the commercially available delayed-release found in Prilosec or Nexium. We suspect that dosing an immediate release omeprazole 12 hours apart (say at night) from Plavix (in the morning) will dramatically reduce the potential negative interactions between the two drugs.
We are optimistic on the development plans for PA-325/40. Besides the potential use as a secondary preventative agent for cardiovascular disease, significant literature exists showing a potential reduction in risk for developing precancerous adenomas on high-dose aspirin regimen.
Four separate government-funded randomized controlled trials concluded that aspirin is a benefit in the prevention of adenomas and significantly reduces the risk of colon cancer. However, the dangerous GI tolerability has greatly limited large outcome-based clinical studies or wide-spread use of high-dose aspirin in colon cancer prevention. We believe that Pozen’s PA-325/40, and phase II PA-650/40, have the potential to be a game-changer with respect to colon cancer prevention. This also helps mitigate the potential downside risk to pushing forward with development despite the recent negative Plavix/PPI headlines. Read the full analyst report on "POZN" Read the full analyst report on "SNY" Read the full analyst report on "BMY" Read the full analyst report on "AZN" Zacks Investment Research
Recently, AstraZeneca plc (AZN) announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its blood clot preventer Brilinta (ticagrelor). Brilinta is an oral reversible P2Y12 adenosine diphosphate receptor antagonist for arterial thrombosis aimed to compete with the blockbuster drug Plavix which is co-developed by Bristol-Myers Squibb (BMY) and Sanofi-Aventis (SNY). On Oct 26, 2009, AstraZeneca filed for approval of the drug with the European Medicines Agency (EMEA) and is awaiting validation of the application.
AstraZeneca is seeking an FDA approval of Brilinta primarily on the basis of data from PLATO (a study of Platelet Inhibition and Patient Outcomes), a late-stage 18,624 patient trial, that showed that Brilinta was more effective than Plavix in treating patients with acute coronary syndrome (ACS) in 43 countries. Brilinta treatment resulted in a reduction of cardiovascular events (CV death, MI or myocardial infarction, stroke) over clopidogrel (Plavix), without an increase in major bleeding. Brilinta is the first investigational antiplatelet that has demonstrated a reduction in CV death versus Plavix in ACS patients.
As a reminder, PLATO evaluated the efficacy, safety and tolerability of Brilinta versus Plavix. The trial design prospectively identified 66 subgroups including 33 efficacy and 33 safety subgroups. The findings from 62 of the 66 subgroups were consistent with the results in the overall study population.
ACS represents conditions that result from a reduction in blood flow to the heart muscle, including unstable angina and myocardial infarction. According to data from the American Heart Association, approximately 1.4 million people in the United States are affected by ACS annually.
We believe that if Brilinta gets FDA approval and enters the approximately $9 billion anticlotting medicine market, it would provide increased competition to Plavix, which is one of the largest selling drugs globally with sales of $5.6 billion in 2008. Plavix already has to contend with a new player in the market, Eli Lilly’s (LLY) Effient. Moreover, Plavix will lose patent protection in 2011 resulting in huge loss of revenues for Bristol. If AstraZeneca can get Brilinta on the market before Plavix goes generic, it may help Brilinta maintain its market share and reduce the number of patients switching to generic clopidogrel.
On 11/19/09, AstraZeneca (NYSE: AZN) announced the submission of a New Drug Application (NDA) to the 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 3 head-to-head trial comparing ticagrelor plus aspirin with clopidogrel (Plavix) plus aspirin. Ticagrelor is the first reversibly binding oral P2Y12 adenosine[More...]
Companies featured in this segment: Fluor Corporation (NYSE:FLR), American Electric Power (NYSE:AEP), Southern Company (NYSE:SO), ReneSola Limited (NYSE:SOL), POSCO (NYSE:PKX), Suntech Power Holdings Company Limited (NYSE:STP), Ormat Technologies Incorporated (NYSE:ORA), Sanofi-Aventis (NYSE:SNY), GlaxoSmithKline plc (NYSE:GSK), Novartis AG (NYSE:NVS), AstraZeneca plc’s (NYSE:AZN), Mitsubishi Corporation (OTC:MSBHY), Sharp Corporation (OTC:SHCAY), CSL Limited (ASX:CSL), Mumias Sugar Company Limited (NBO:MSCL), Athi River Mining Limited (NBO:ARM), Kenya Power & Lighting Company Limited (NBO:KPLA), Daewoo Engineering & Construction Company Limited (SEO:047040)
Companies featured in this segment: General Electric Company (NYSE:GE), Hitachi Limited (NYSE:HIT), Areva AstraZeneca plc (NYSE:AZN), Biogen Idec Incorporated (NASDAQ:BIIB), Cameco Corporation (NYSE:CCJ), BHP Billiton Limited (NYSE:BHP), ING Groep NV (NYSE:ING), Rio Tinto (NYSE:RTP), Siemens AG (NYSE:SI), Total SA (NYSE:TOT), HSBC (NYSE:HBC), Toshiba Corporation (TYO:6502), General Electric Company (NYSE:GE), Hitachi Corporation (NYSE:HIT), Korea Electric Power Corporation (NYSE:KEP), Hyundai Engineering and Construction Company (SEO:000720), BNP Paribas SA (OTC:BNPQY), Marubeni Corporation (TYO:8002), Sumitomo Corporation (TYO:8053), Uranium One Incorporated (TSX:UUU), E.ON AG (OTC:EONGY), RWE AG (OTC:RWEOY), Areva SA (EPA:CEI), and GDF Suez SA (EPA:GSZ)
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