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AstraZeneca Group plc (AZN)

  • Sep. 23, 2014, 12:31 PM
    • Monday, September 29 is the PDUFA date for Relistor's sNDA (methylnaltrexone bromide) for the treatment of opioid-induced constipation (OIC).
    • Salix (SLXP +5%) successfully appealed the FDA's CRL for the indication in July.
    • (PGNX +0.6%)(NKTR +1.8%)(AZN -4%)(CBST +0.6%)(SGYP +3.1%)
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  • Sep. 23, 2014, 9:10 AM
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  • Sep. 23, 2014, 7:45 AM
    • U.S. Treasury Secretary Jack Lew says that the Obama Administration is prepared to institute rules to stop tax inversion deals. If so, it will do so without a sliver of Republican support. Barclays analyst Michael Leuchten says, "Washington is playing for time. It makes them look good and it allows Congress to maybe get its act together and maybe do something on the legislative side."
    • Mr. Lew's comments have spooked the market a bit. European companies already involved in deals or rumored to be targets are all under pressure due to the perception that some of the deals already announced may be at risk.
    • The U.S. firm in the best position is Horizon Pharma (NASDAQ:HZNP). It completed its tax inversion transaction with Ireland-based Vidara Therapeutics last week.
    • Related tickers: (MDT -0.4%)(COV -0.5%)(ABBV -0.6%)(SHPG -0.7%)(OTCQB:SHPGF -1.5%)(PFE -0.7%)(AZN -0.1%)(SNN +0.1%)(SYK -0.8%)
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  • Sep. 19, 2014, 7:18 AM
    • The European Commission approves Novo Nordisk's (NYSE:NVO) Xultophy for the treatment of adult patients with type 2 diabetes to improve glycemic control in combination with oral glucose-lowering medicines when these alone or combined with basal insulin do not provide adequate glycemic control.
    • Xultophy (IDegLira) is a once-daily injection combination of insulin degludec (Tresiba) and liraglutide (Victoza).
    • Novo plans to launch the product in Europe in 1H 2015.
    • Related tickers: (NYSE:NVS) (NYSE:LLY) (NYSE:MRK) (NYSE:SNY) (NYSE:AZN) (NYSE:GSK)
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  • Sep. 18, 2014, 4:03 PM
    • The FDA approves Eli Lilly's (LLY +1.1%) Trulicity (dulaglutide), a once-weekly subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.
    • Trulicity is a glucagon-like peptide-1 (GLP-1) receptor agonist, a hormone that helps normalize blood sugar levels.
    • Related tickers: (NVS +0.1%) (MRK +0.7%) (SNY +0.7%)(AZN +1.3%)(GSK +0.4%)
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  • Sep. 16, 2014, 10:51 AM
    • The FDA approves Nektar Therapeutics' (NKTR -0.1%) Movantik (naloxegol) for the treatment of patients with opioid-induced constipation who take opioids for the management of chronic non-cancer pain.
    • Movantik is distributed by AstraZeneca (AZN -0.9%).
    • Related tickers: (PGNX -0.2%) (SLXP +3.7%) (CBST +0.1%)
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  • Sep. 16, 2014, 3:29 AM
    • After stating its intention in May to find a partner for its experimental Alzheimer's drug, AstraZeneca (NYSE:AZN) has now agreed to team up with Eli Lilly (NYSE:LLY).
    • Under the terms of the agreement, Lilly will pay AstraZeneca up to $500M, depending on the progress of the drug, which is now set to enter late-stage Phase 3 development.
    • The companies will share all costs associated with the "BACE inhibitor drug", as well as net global revenues after its launch.
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  • Sep. 15, 2014, 12:05 PM
    • Barron's Ben Levisohn believes that AstraZeneca (AZN +0.7%) remains a solid target for Pfizer (PFE +0.9%) citing the tax inversion appeal, the ability to free up its ex-U.S. cash and AZN's robust pipeline.
    • He also believes Actavis (ACT -0.2%) is an equally compelling target due to its lower risk and good fit with Pfizer's Global Established Product unit while offering the tax inversion pathway and access to ex-U.S. cash as well.
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  • Sep. 8, 2014, 8:38 AM
    • AstraZeneca's (NYSE:AZN) product candidate for the treatment of patients with chronic obstructive pulmonary disease, benralizumab, fails to achieve its primary efficacy endpoint of a reduction in the acute exacerbation rate versus placebo in a 101-patient Phase 2a clinical trial, although it did demonstrate clinically significant improvements in lung function.
    • Benralizumab is an anti-interleukin-5 receptor alpha monoclonal antibody that depletes blood and sputum eosinophils, a type of white blood cell. Eosinophils are associated with the cause and severity of COPD attacks, as well as asthma. As many as 30% of the 210M people who suffer from COPD have eosinophilic airway inflammation.
    • Despite the apparent setback, AstraZeneca is proceeding with a Phase 3 trial evaluating the safety and efficacy of benralizumab in COPD.
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  • Sep. 3, 2014, 9:16 AM
    • The U.K. High Court rules in favor of Teva Pharmaceutical Industries (NYSE:TEVA) in its case challenging the validity of AstraZeneca's (NYSE:AZN) patent (EP 1,085,877) covering the SMART (Single inhaler Maintenance And Reliever Therapy) indication for AZN's fixed dose formoterol/budesonide combination product, Symbicort.
    • The Court agreed with Teva's position that AZN's SMART patent is obvious and rejected AZN's proposed amendments on the basis that they added matter.
    • The ruling facilitates Teva's European launch of DuoResp Spiromax, its version of a formoterol/budesonide fixed dose combination product.
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  • Sep. 1, 2014, 5:43 AM
    • A clinical study presented at the European Society of Cardiology congress has concluded that AstraZeneca's (NYSE:AZN) heart drug Brilinta is safe to use in an ambulance when heart attack patients are being rushed to hospital, although its early use does not provide any extra benefit.
    • Some experts had hoped that a Brilinta-aspirin combo taken before the patient arrives would further boost the chance of restoring healthy blood flow to the heart by minimizing delays.
    • However, prospects for the drug did improve last month, after the U.S. government closed an investigation into a major clinical trial of Brilinta that was used to win marketing approval.
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  • Aug. 21, 2014, 11:47 AM
    • Some observers believe Pfizer (PFE -0.4%) will rekindle its bid for AstraZeneca (AZN +3%) by late 2014. The British firm rejected its ₤71B offer in May. Pfizer walked away despite being within 7% of the price AstraZeneca wanted.
    • Under British takeover rules, the negotiations could restart as early as August 26 if AstraZeneca invites Pfizer back to the table. Pfizer cannot initiate discussions until November 26. The rules also allow Pfizer to make a single offer via private phone call to AstraZeneca but this option is rarely used because the process stops if the target says no.
    • It all depends on Ian Read's enthusiasm for a higher bid. This may be unlikely considering what happened in May.
  • Aug. 21, 2014, 8:07 AM
    • Ilumina (NASDAQ:ILMN) has formed collaborative partnerships with AstraZeneca (NYSE:AZN), Janssen Biotech (NYSE:JNJ) and Sanofi (NYSE:SNY) to develop a universal next-generation sequencing (NGS) system focused on oncology. The system will employ an multi-gene panel that will be used for patient selection in clinical trials of targeted cancer therapies. Illumina plans to commercialize the tests after obtaining regulatory approval.
    • The emergence of panel-based assays will be a paradigm shift from today's single-analyte companion diagnostics.
    • An estimated 800 oncology drugs are in development worldwide. At present, 125 cancer driver genes, 71 tumor suppressors and 54 oncogenes that drive tumor growth through 12 cellular signalling pathways have been discovered.
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  • Aug. 19, 2014, 1:17 PM
    • Boehringer Ingelheim commences patient enrollment in its international Phase 3 trial evaluating the safety and efficacy of its oral anticoagulant dabigatran etexilate in patients with non-valvular atrial fibrillation (AF) who have undergone a percutaneous coronary intervention (PCI) with stent placement. Patients in this population have a higher risk of stroke due to blood clots from the heart and from the stent.
    • The 8,500-patient study will compare dabigatran etexilate plus clopidogrel or ticagrelor versus the current standard triple antithrombotic therapy of warfarin plus clopidogrel or ticagrelor plus acetylsalicylic acid.
    • Related tickers: (BMY -0.2%) (MRK +0.1%) (NVS +1.2%) (AZN +0.3%)
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  • Aug. 19, 2014, 7:40 AM
    • AstraZeneca (NYSE:AZN) discloses top-line results from two Phase 3 clinical trials evaluating the safety and efficacy of CAZ-AVI (ceftazidime-avibactam) as a treatment for hospitalized patients with complicated intra-abdominal infections. CAZ-AVI was administered as a two-hour IV infusion plus metronidazole compared to meropenem administered as a 30-minute IV infusion.
    • CAZ-AVI demonstrated non-inferiority (no worse than) to meropenum but nothing is disclosed about achieving the primary endpoint of a clinical cure rate 28 to 35 days after randomization. The adverse event rate was similar to meropenem.
    • CAZ-AVI is an investigational antibiotic being developed to treat serious Gram-negative bacterial infections. It consists of ceftazidime, a third-generation antipseudomonal cephalosporin and avibactam, a next-generation non-beta lactam beta-lactamase inhibitor. The additional of avibactam prevents ceftazidime from being broken down by serine-beta-lactamases which are produced by certain bacteria.
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  • Aug. 19, 2014, 4:45 AM
    • AstraZeneca (NYSE:AZN) says that the U.S. government has closed a probe that investigated a major clinical trial used to win marketing approval for the company's new heart drug Brilinta.
    • Following the DOJ's investigation into the study last October, doubts have ensued over the medicine's future success.
    • AstraZeneca argues that Brilinta can bring in $3.5B in annual sales, although until now the drug has not made any record performance.
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Company Description
AstraZeneca PLC is a biopharmaceutical company focusing on three areas of healthcare: Cardiovascular and Metabolic disease (CVMD); Oncology; and Respiratory, Inflammation and Autoimmunity (RIA).