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GlaxoSmithKline (GSK)

  • Nov. 14, 2014, 7:07 AM
    • In order to improve its growth prospects, GlaxoSmithKline (NYSE:GSK) plans to sell its portfolio of older prescription medicines sold in North America and western Europe. The group includes Paxil, Imitrex, Zantac and Zofran. The company plans to retain the rights to the drugs in emerging markets where their growth is higher and it intends to retain ownership in its manufacturing facilities.
    • Potential buyers, who will have to outsource manufacturing and distribution operations, include Leon Black's Apollo Global Management and KKR.
    • The product group's 2014 sales will be ~₤1B ($1.6B) but are declining due to the encroachment of generic competitors. Sources say Glaxo seeks a price of 2x sales or $3.2B.
  • Nov. 12, 2014, 12:01 PM
    • GlaxoSmithKline (GSK -0.7%) submits a variation to its Marketing Authorization in the European Union for Revolade (eltrombopag) seeking approval for the treatment of patients with severe aplastic anemia (SAA) who have had an insufficient response to immunosuppressive therapy. The FDA approved the use of eltrombopag for SAA on August 26, 2014.
    • Revolade's current labeling in Europe is for the treatment of thrombocytopenia in patients with chronic immune thrombocytopenic purpura and patients with chronic hepatitis C to allow them to initiate and maintain interferon-based therapy.
    • The European Commission usually issues a final decision within 60 days.
    • Eltrombopag was co-discovered by Glaxo and Ligand Pharmaceuticals (LGND +0.2%).
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  • Nov. 11, 2014, 4:52 PM
    • A Phase 3 study evaluating Amgen's (NASDAQ:AMGN) brodalumab versus Janssen's (NYSE:JNJ) Stelara (ustekinumab) and placebo at week 12 in patients with moderate-to-severe plaque psoriasis met its primary endpoints. Brodalumab was superior to ustekinumab in achieving total clearance of skin disease as measured by PASI-100. Compared to placebo, a significantly greater proportion of patients treated with brodalumab achieved at least a 75% improvement from baseline in disease severity at week 12 (measured by PASI-75). All key secondary endpoints were also met.
    • Proportion of patients achieving total clearance of disease: brodalumab-210 mg: 36.7%; brodalumab-140 mg: 27.0%; Stelara: 18.5%; placebo: 0.3%.
    • Proportion of patients achieving PASI-75: brodalumab-210 mg: 85.1%; brodalumab-140 mg: 69.2%; Stelara: 69.3%; placebo: 6.0%.
    • Amgen plans to present the complete results at a future medical conference.
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  • Nov. 11, 2014, 7:44 AM
    • Dupilumab, a fully-human monoclonal antibody being co-developed by Sanofi (NYSE:SNY) (OTCQB:SNYNF) and Regeneron Pharmaceuticals (NASDAQ:REGN), showed showed positive results in a 776-patient Phase 2b dose-ranging clinical trial in adults with moderate-to-severe uncontrolled asthma.
    • The three highest doses of dupilumab in combination with standard-of-care therapy met the primary endpoint of a statistically significant improvement from baseline in forced expiratory volume over one second (FEV1) at week 12 in patients with high blood eosinophils (>= 300 cells/microliter) compared to placebo in combination with standard-of-care therapy. Also, two doses of dupilumab (200 mg every other week and 300 mg every other week) showed a statistically significant improvement in mean percent change in FEV1 and a reduction in severe exacerbations, both in the high eosinophils group and the overall study population.
    • Dupilumab blocks IL-4 and IL-13, two cytokines required by the Th2 immune response. Some researchers believed that targeting the Th2 pathway would limit the benefit in asthmatics with high eosinophils, but this study demonstrated that it could be effective. Final results from the trial will be presented at a future medical conference.
    • Sanofi plans to proceed to Phase 3 development.
  • Nov. 6, 2014, 10:20 AM
    • In a 56-patient Phase 2 clinical trial, GlaxoSmithKline's (GSK -0.5%) plaque psoriasis drug candidate, GSK2856184, demonstrated encouraging efficacy compared to placebo and Celgene's Otezla (apremilast).
    • After a treatment period of up to 12 weeks, the proportion of PASI 50, 75 and 90 responders who received 400 mg twice per day (BID) was 69%, 62% and 38%, respectively, compared to placebo's 0% and Otezla's 33% for PASI 75.
    • GSK2856184 is a JAK1 inhibitor licensed from Mechelen, Belgium-based Galapagos NV. Otezla is a PDE4 inhibitor.
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  • Nov. 5, 2014, 8:52 AM
    • GlaxoSmithKline (NYSE:GSK) files regulatory submissions in the U.S. and Europe for its IL-5 inhibitor, mepolizumab, for the treatment of asthma.
    • The Biologics License Application submitted to the FDA specifies mepolizumab as an add-on maintenance treatment for severe eosinophilic asthma in patients aged 12 years and older with a history of exacerbations.
    • The Marketing Authorization Application submitted to the EMA specifies mepolizumab as an add-on treatment for severe eosinophilic asthma in adult patients with a history of exacerbations and/or dependency on systemic corticosteroids.
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  • Nov. 3, 2014, 1:06 PM
    • The FDA accepts Boehringer Ingelheim's NDA for Spiriva Respimat (tiotropium bromide) for the maintenance treatment of asthma in patients at least 12 years old who remain symptomatic on at least inhaled corticosteroids.
    • Spiriva is currently cleared for the maintenance treatment of bronchospasm (HandiHaler) associated with chronic obstructive pulmonary disease (COPD) and to reduce COPD exacerbations.
    • The Respimat inhaler provides a pre-measured amount of medicine in a slow moving mist that helps the patient inhale the drug. It is designed to deliver the medication in a way that does not depend on how fast air is breathed in from the inhaler.
    • Asthma and COPD-related tickers: (THRX -3%)(GSK -0.3%)(AZN -0.8%)(NVS -1.3%)(REGN +0.6%)(SNY -1.5%)(TEVA +1.5%)(OTCQX:RHHBY -1.3%)
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  • Nov. 3, 2014, 12:09 PM
    • Isis Pharmaceuticals (ISIS +0.2%) earns a $5M milestone from GlaxoSmithKline (GSK -0.3%) for the designation of ISIS-GSK5rx as a development candidate for an undisclosed ocular disease. It is the second drug to be so identified in its collaboration with GSK. It earned a $1M milestone in July for a drug candidate to treat hepatitis B infection.
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  • Oct. 27, 2014, 6:43 AM
    • Novartis (NYSE:NVS) sells its global influenza vaccine business to Australian blood products firm CSL Ltd. for $275M. The transaction, part of Novartis' effort to focus on its most promising assets, concludes the company's overhaul of its units. The deal is expected to close in 2H 2015.
    • Earlier this year, GlaxoSmithKline (NYSE:GSK) bought its vaccine business, ex-flu, for $5.25B plus milestones up to $1.8B and royalties.
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  • Oct. 23, 2014, 4:50 PM
    • Thinly-traded micro cap Five Prime Therapeutics (FPRX +0.8%) expands its respiratory disease research collaboration with GlaxoSmithKline (GSK +2.1%). The partners agree to extend the two additional disease programs that were initiated in April for a six-month evaluation period for an additional 18 months.
    • Under the terms of the expansion, Five Prime will receive $2M in research funding ($500K already received) and up to $193.8M in option exercise fees and milestones as well as tiered royalties on net sales.
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  • Oct. 23, 2014, 6:09 AM
    • Drugmakers are looking for some kind of indemnity from governments or multilateral agencies for the emergency use of new Ebola vaccines in Africa.
    • GlaxoSmithKline (NYSE:GSK) Chief Executive Andrew Witty says a system of indemnity makes sense given the unique situation in which companies are being urged by the WHO to expedite vaccines in a matter of months rather than years.
    • The concern will likely be discussed at a high-level WHO meeting in Geneva today, which includes industry execs, drug regulators and funders.
    • Europe is also expected to announce €200M ($250M) of funding to develop new Ebola vaccines, as well as drugs and diagnostic tests.
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  • Oct. 22, 2014, 8:56 AM
    • GlaxoSmithKline (NYSE:GSK) Q3 results (₤M): Total Revenues: 5,646 (-13.3%), Pharmaceuticals: 3,653 (-13.2%), Vaccines: 922 (-6.6%), Consumer Health: 1,071 (-18.4%); COGS: 1,829 (-13.4%); R&D Expense: 803 (-10.8%); SG&A Expense: 2,013 (+1.5%); Net Income: 1,341 (+38.4%); EPS: 0.082 (-58.4%); CF Ops: 1,273 (-38.7%); Quick Assets: 5,122 (+27.8%).
    • Gross Profit: 3,817 (-13.2%); COGS: 32.4% (-0.1%); Gross Margin: 67.6% (0.0%); Operating Profit: 703 (-55.2%); Operating Earnings Yield: 12.5% (-48.3%); Net Earnings Yield: 23.8% (+59.6%).
    • 2014 Guidance: EPS growth: flat.
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  • Oct. 22, 2014, 7:57 AM
    • GlaxoSmithKline (NYSE:GSK): Q3 EPS of 27.9p
    • Revenue of £5.65B (-3% Y/Y).
    • Q3 dividend maintained at 19p.
    • Shares +2% PM.
    • Press Release (.pdf)
  • Oct. 20, 2014, 10:40 AM
    • Laboratory Corporation of America (LH -0.2%) launches its HIV GenoSure Archive, the first laboratory test that helps clinicians optimize antiretroviral (ARV) drug regimens for virally suppressed HIV patients. The test was developed using the Next Generation Sequencing Platform (NGS).
    • Previous lab testing to guide ARV drug selection required higher viral loads than many HIV patients have. GenoSure Archive is performed by amplifying cell-associated HIV-1 DNA from infected cells in whole blood samples and then analyzing the polymerase region using NGS methods. The assay is analytically validated to identify mutations associated with resistance to all members of the most widely used ARV drug classes.
    • HIV-related tickers: (ABBV +1.2%)(GILD +1.6%)(BMY +0.1%)(PFE -0.2%)(GSK -0.3%)(ABT +0.2%)(JNJ +0.1%)(PGNX +3%)(MRK +0.1%)(OTCQX:RHHBY +0.6%)
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  • Oct. 20, 2014, 8:56 AM
    • Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi (NYSE:SNY) (OTCQB:SNYNF) initiate a Phase 3 clinical trial to assess the safety and efficacy of dupilumab administered concomitantly with topical corticosteroids for the treatment of adults with moderate-to-severe atopic dermatitis (AD). The 16-week randomized, double-blind, placebo-controlled multinational study will enroll ~700 patients.
    • Dupilumab is a fully-human mAb that blocks IL-4 and IL-13 signalling. It was created using Regeneron's VelocImmune technology and is being co-developed with Sanofi.
    • Dermatitis-related tickers: (NYSE:VRX) (NASDAQ:ANAC) (NYSE:GSK) (NYSE:PRGO)
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  • Oct. 19, 2014, 6:07 PM
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Company Description
GlaxoSmithKline PLC incorporated in United Kingdom. The Company creates, discoveres, develops, manufactures and markets pharmaceutical products including vaccines, over-the-counter (OTC) medicines and health-related consumer products.