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AstraZeneca Group plc (AZN)

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  • Today, 10:51 AM
    • AstraZeneca (AZN -2%) and Innate Pharma SA (OTCPK:IPHYF) establish a collaboration to accelerate and broaden the development of Innate's proprietary anti-NKG2A antibody, IPH2201, including the combination with MEDI4736, a PD-L1 checkpoint inhibitor.
    • The initial plan includes Phase 2 studies of the combination in solid tumors, multiple Phase 2s involving IPH2201 as monotherapy and in combination with currently approved treatments across a range of cancers and the development of associated biomarkers.
    • Under the terms of the agreement, Innate will receive an initial payment of $250M, $100M prior to the initiation of Phase 3 development, regulatory- and sales-based milestones and double digit royalties. Innate has the right to co-promote in Europe for a 50% profit share. AstraZeneca will have exclusive global rights to commercialize IPH2201 in combination with MEDI4736 as well as access to IPH2201 in monotherapy and other combinations in certain treatment areas.
    • IPH2201 is a humanized IgG4 antibody, an immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor-infiltrating cytotoxic NK (natural killer) and CD8 T lymphocytes. Blocking the inhibitory function of CD94/NKG2A enhances the ability of NK and T cells to kill cancer cells.
    • MEDI4736 is a human monoclonal antibody that binds to PD-L1, a protein found on the surface of cancer cells that allows them to avoid detection by the immune system. Binding to PD-L1 enables T cells to recognize and kill cancer cells.
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  • Today, 8:15 AM
    • Celgene (NASDAQ:CELG) subsidiary Celgene International II Sarl and AstraZeneca (NYSE:AZN) subsidiary MedImmune enter into a strategic collaboration to develop and commercialize MEDI4736, MedImmune's human monoclonal antibody against programmed cell death ligand 1 (PD-L1), for hematologic malignancies. PD-L1 is a protein found on the surface of cancer cells that enable them to avoid detection by the immune system. Binding to PD-L1 enables T cells to recognize and kill cancer cells.
    • The partnership will explore the potential for combination therapies of MED4736 and Celgene's pipeline product candidates in blood cancers.
    • Under the terms of the agreement, Celgene will make an upfront payment of $450M. It will lead clinical development for all clinical trials and pay all costs associated with the trials through 2016. Afterward, it will be responsible for 75% of the costs. Celgene has global commercialization rights to MEDI4736 for hematology indications and will receive royalty rates starting at 70% of worldwide sales in hematology, gradually decreasing to 50% over time.
    • Yesterday, MedImmune announced a collaboration with Juno Therapeutics to develop MEDI4736 with a CAR-T therapy for non-Hodgkin lymphoma.
    • Previously: Juno and AstraZeneca team up in combo treatment for blood cancer (April 23)
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  • Today, 6:16 AM
    • AstraZeneca (NYSE:AZN): Q1 EPS of $1.08 beats by $0.03.
    • Revenue of $5.75B (-10.4% Y/Y) misses by $200M.
    • Shares -2.78% PM.
    • Press Release
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  • Yesterday, 5:30 PM
  • Yesterday, 1:00 PM
    • Juno Therapeutics (JUNO +1.7%) and AstraZeneca's (AZN -0.3%) MedImmune enter into a collaboration to explore the potential of the combination of one of Juno's CD19-directed chimeric antigen receptor (CAR)-T cell candidates with MedImmune's investigational programmed cell death ligand 1 (PD-L1) immune checkpoint inhibitor, MEDI4736, for the treatment of non-Hodgkin lymphoma.
    • Under the initial development plan, both companies will explore the safety, tolerability and preliminary efficacy of the combination therapy by co-funding a Phase 1b study, expected to commence later this year. The firms will also explore the combination of MEDI4736 with a next-generation CD19-directed CAR-T developed by Juno.
    • MEDI4736 is a human monoclonal antibody that binds to PD-L1, a protein on the surface of cancer cells that enables them to avoid detection by the immune system. Blocking PD-LI enables the immune system to identify and kill the cancer cells.
    • Juno's CAR-T technology genetically engineers a patient's T cells to recognize and kill cancer cells by inserting a gene for a particular CAR into the T cell, enabling it to recognize a specific protein on the surface of the cancer cell.
    • Financial details are not disclosed.
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  • Fri, Apr. 17, 7:58 AM
    • Based on an interim analysis of its ongoing AURA study, AstraZeneca's (NYSE:AZN) experimental cancer drug, AZD9291, demonstrated a median progression-free survival (PFS) of 13.5 months in patients with advanced epidermal growth factor receptor mutation positive (EGFR+) non-small cell lung cancer (NSCLC) who also have the T790M mutation. T790M-positive NSCLC patients with disease progression do not have effective treatment options. Management is usually limited to chemotherapy or re-challenge with EGFR tyrosine kinase inhibitors (TKI) like erlotinib (Roche's Tarceva) or gefitinib (AZN's Iressa).
    • The updated data also show an overall response rate of 54% (80 mg dose) and a median duration of response of 12.4 months. The data were presented at the European Lung Cancer Conference in Geneva, Switzerland.
    • NSCLC is the most common form of lung cancer. The T790M mutation is responsible for up to 67% of EGFR TKI resistance in patients with advanced EGFR+ NSCLC.
    • The company plans to submit its regulatory application in the U.S. this quarter. Management believes peak sales could reach $3B per year.
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  • Fri, Apr. 17, 7:09 AM
    • The FDA designates AstraZeneca's (NYSE:AZN) selumetinib an Orphan Drug for the treatment of uveal melanoma, a rare disease in which cancer cells form in the tissues of the eye. It is the most common primary intraocular malignancy in adults. The incidence is 4.3 cases per 1M people and peaks near the age of 70.
    • Among the benefits of Orphan Drug status is a seven-year period of market exclusivity for the indication, if approved.
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  • Wed, Apr. 15, 9:57 AM
    • The FDA designates AstraZeneca's (AZN +1.4%) anti-CTLA-4 monoclonal antibody, tremelimumab, an Orphan Drug for the treatment of malignant mesothelioma, an aggressive cancer affecting the lining of the lungs and abdomen that is associated with asbestos exposure.
    • Among the benefits of Orphan Drug status is a seven-year period of market exclusivity for the indication, if approved.
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  • Tue, Apr. 14, 3:21 PM
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  • Mon, Apr. 13, 9:03 AM
    • AstraZeneca (NYSE:AZN) signs a five-year agreement with PatientsLikeMe to provide access to the latter's 325K+ members. It intends to use the patient-reported data to help improve outcomes across its therapeutic areas. The initial focus will be on respiratory disease, lupus, diabetes and oncology.
    • EVP, Global Medicines Development Briggs Morrison says, "Understanding what patients are experiencing every day and how they define the value of their treatments are fundamental to our ability to push the boundaries of science in developing the next-generation of medicines. Our partnership with PatientsLikeMe will help us to harness the important perspectives of patients through their advanced technology and real-world, real-time evidence to support our research and development programs."
    • Financial terms are not disclosed.
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  • Fri, Apr. 10, 11:51 AM
    • The FDA's Endocrinologic and Metabolic Drugs Advisory Committee meets on April 14 to review the data from a large scale cardiovascular (CV) outcomes trial that assessed if there was an effect on cardiovascular risk in type 2 diabetic patients taking AstraZeneca's (AZN -0.3%) saxagliptin [Onglyza (saxagliptin) or Kombiglyze XR (saxagliptin and metformin HCl)]. The Phase 4 study was a condition of the FDA's approval of the company's New Drug Application (NDA) in July 2009.
    • The randomized, double-blind, placebo-controlled trial, called SAVOR, involved 16,492 high-CV risk patients with type 2 diabetes. The primary endpoint was the CV safety of saxagliptin as measured by the incidence of major adverse cardiac events (MACE). A MACE event was defined as CV death, non-fatal cardiac infarction (heart attack) or non-fatal ischemic stroke. The objective was to demonstrate saxagliptin's non-inferiority (no worse than) to placebo in its effect on CV risk.
    • According to AstraZeneca's briefing document, SAVOR was successful in demonstrating saxagliptin's non-inferiority to placebo. There was also no statistical difference in the broader endpoint of the incidences of MACE and hospitalizations for unstable angina, heart failure or coronary revascularization between the groups.
    • There was a higher incidence of all-cause mortality in the saxagliptin cohort, although it could not attributed to the drug. The study did show higher risk for hospitalization for heart failure (HF) in patients at increased risk for HF (those with a history of HF or renal impairment). A labeling change will most likely be required to address this subgroup.
    • Briefing doc
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  • Thu, Apr. 9, 8:57 AM
    • The FDA designates MedImmune's (NYSE:AZN) RSV antibody, MEDI8897, for Fast Track review for the prevention of lower respiratory tract illness caused by respiratory syncytial virus (RSV) in infants and young children.
    • MEDI8897 is an investigational human immunoglobulin G1 kappa monoclonal antibody that neutralizes RSV by binding to the pre-fusion structure of the RSV fusion protein expressed on the virus and infected cells. MEDI8897 is based on the D25 antibody developed by AIMM Therapeutics.
    • Fast Track status allows for more frequent interactions the FDA review team and a rolling review of the New Drug Application (NDA).
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  • Wed, Apr. 8, 8:53 AM
    • The Defense Advanced Research Projects Agency (DARPA) awards a two-year $21M grant to a collaborative team led by Inovio Pharmaceuticals (NASDAQ:INO) to develop multiple treatment and prevention regimens against Ebola. Other members include GeneOne Life Sciences, MedImmune (NYSE:AZN), Professor David B. Weiner, Ph.D. (University of Pennsylvania), Emory University and Vanderbilt University.
    • Development programs include a therapeutic DNA-based monoclonal antibody (dMab) and a protein-based therapeutic monoclonal antibody (mAb) against Ebola infection and Inovio's DNA-based Ebola vaccine (the first patient is expected to be dosed this quarter).
    • The grant includes an option award of $24M and an additional option of $11M to support product supply and clinical development activities. Both options are contingent on the successful completion of certain development milestones.
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  • Tue, Apr. 7, 7:51 PM
    • Small cap Regulus Therapeutics (NASDAQ:RGLS) jumps 11% after hours on robust volume in response to its announcement that AstraZeneca (NYSE:AZN) will proceed with the clinical development of RG-125 for the treatment of nonalcoholic steatohepatitis (NASH) in type 2 diabetics. This is the first product candidate to be advanced through clinical trials under the companies' 2012 strategic alliance. Under the terms of the agreement, AstraZeneca's will assume responsibility for the development of RG-125 as well as pay Regulus a $2.5M milestone fee. A Phase 1 trial should commence by year-end. Both firms will submit preclinical data on the RG-125 program to be presented at a future scientific meeting.
    • RA-125 is a GalNAc (N-Acetylgalactosamine) -conjugated anti-miR targeting microRNA-103/107 (miR-103/107). MicroRNAs are small non-coding RNAs that regulate gene expression. miR-103/107 plays a key role in insulin sensitivity. Inhibiting miR-103/107 leads to a sustained reduction in fasting glucose and fasting insulin levels and decreases liver triglycerides and steatosis.
    • GalNAc-conjugation is the most effective way to deliver a subcutaneous dose of an RNA-based therapeutic.
    • Previously: Regulus Therapeutics enters into a strategic alliance with AstraZeneca (AZN) to discover,... (Aug. 14, 2012)
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  • Thu, Apr. 2, 12:00 PM
    • AstraZeneca's (AZN -0.2%) U.S. launch of Movantik (naloxegol) triggers a $100M milestone payment to developer Nektar Therapeutics (NKTR -0.8%) as stipulated in their license agreement signed in September 2009. It will also receive an initial royalty rate of 20% on net sales that will escalate as sales ramp up.
    • Nektar is also entitled to a $40M milestone payment upon the first Movantik sale in Europe with a royalty rate of 18% that will escalate as sales increase. Total sales-based milestones could reach as high as $375M.
    • AstraZeneca has responsibility for all sales and marketing activities for Movantik worldwide. Movantik is indicated for the treatment of opioid-induced constipation in adults with chronic, non-cancer pain.
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  • Wed, Apr. 1, 8:50 AM
    • Myriad Genetics (NASDAQ:MYGN) and AstraZeneca (NYSE:AZN) expand their companion diagnostic collaboration using Myriad's BRACAnalysis CDx test to prospectively identify patients with metastatic pancreatic cancer who may respond to treatment with AZN's Lynparza (olaparib).
    • BRACAnalysis CDx is an in vitro diagnostic device that detects and classifies variants of BRCA1 and BRCA2 genes using genomic DNA from whole blood specimens. The FDA approved it in December 2014 as a companion diagnostic for Lynparza for ovarian cancer.
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Company Description
AstraZeneca PLC is a biopharmaceutical company. It is engaged in the discovery and development of new products, which are then manufactured, marketed and sold.