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Theravance, Inc. (THRX)

  • Mon, Mar. 23, 4:26 PM
    • According to Thomson Reuters' 2015 Drugs to Watch report, as many as 11 blockbuster drugs (peak sales of at least $1B within five years) are expected to clear the regulatory process this year. This is a significant jump from 2014's tally of three (Gilead's (NASDAQ:GILD) Sovaldi and Zydelig; Glaxo (NYSE:GSK) and Theravance's (NASDAQ:THRX) Anoro Ellipta). In reverse order (forecasted 2019 consensus sales in parentheses):
    • 11. Novartis' (NYSE:NVS) Cosentyx (secukinumab) for psoriasis and psoriatic arthritis ($1.08B); 10. Sanofi's (NYSE:SNY) Toujeo (insulin glargine) for diabetes ($1.26B); 9. Otsuka Pharmaceutical (OTCPK:OTSKY) and Lundbeck's (OTCPK:HLUYY) Brexpiprazole for schizophrenia and depression ($1.35B); 8. Merck's (NYSE:MRK) Gardisil 9 HPV vaccine ($1.64B); 7. Amgen's (NASDAQ:AMGN) evolocumab for hypercholesterolemia/hyperlipidemia ($1.86B); 6. AbbVie's (NYSE:ABBV) Veikira Pak for hepatitis C (cleared 12/19/14) ($2.5B); 5. Vertex Pharmaceuticals' (NASDAQ:VRTX) lumacaftor plus ivacaftor for cystic fibrosis ($2.74B); 4. Pfizer's (NYSE:PFE) Ibrance (palbociclib) for breast cancer ($2.76B); 3. Novartis' LCZ696 for chronic heart failure ($3.73B); 2. Regeneron Pharmaceuticals' (NASDAQ:REGN) Praluent (alirocumab) for hypercholesterolemia ($4.41B) and 1. Bristol-Myers Squibb's (NYSE:BMY) Opdivo (nivolumab) for melanoma ($5.68B).
  • Fri, Mar. 20, 9:23 AM
  • Thu, Mar. 19, 7:24 PM
    • Theravance (NASDAQ:THRX) has fallen to $16.11 in AH trading after the FDA advisory committee backed the use of GlaxoSmithKline's Breo Ellipta inhaler for treating asthma in adults, but not in adolescents.
    • Theravance, which co-developed Breo Ellipta with Glaxo and receives royalties on its sale, was halted today in advance of the decision. CEO Michael Aguiar, discussing the decisions in a PR: "We remain committed to the ongoing review process and will be fully cooperating with the FDA to ensure it has all it needs to consider the sNDA for Breo Ellipta in asthma. We look forward to the final outcome expected in April."
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  • Thu, Mar. 19, 4:05 PM
    • The FDA joint advisory committee reviewing Glaxo's (NYSE:GSK) sNDA for the use of Breo Ellipta to treat asthma voted 17 - 3 in favor that the safety data was adequately demonstrated in adults with asthma.
    • It voted 18 - 2 in favor of its efficacy in adults at least 18 years old, but 16 - 4 against the data showing a benefit in adolescents ages 12 - 17 years.
    • Related ticker: (NASDAQ:THRX)
    • Previously: Ad Comm meeting approaches for expanded indication for Glaxo's COPD med (March 17)
  • Thu, Mar. 19, 11:26 AM
    • The joint meeting of the FDA's Pulmonary-Allergy Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee is in session today to review Glaxo's sNDA seeking approval for the use of Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) in patients with asthma.
    • Trading in development partner Theravance (THRX) has been halted pending news of the committees' decision.
    • Previously: Ad Comm meeting approaches for expanded indication for Glaxo's COPD med (March 17)
  • Wed, Mar. 18, 7:45 AM
    • Two 24-week Phase 3 trials (PINNACLE 1 & 2) evaluating AstraZeneca's (NYSE:AZN) PT003 in patients with chronic obstructive pulmonary disease (COPD) achieved their primary efficacy endpoints of statistically significant improvement in lung function compared to placebo.
    • PT003 is a twice-daily fixed-dose combination of glycopyrronium, a long-acting muscarinic antagonist (LAMA) and formoterol fumarate, a long-acting beta-2 agonist (LABA). It is the first LAMA/LABA combination to be delivered in a pressurized metered dose inhaler using the porous particle co-suspension technology developed by Pearl Therapeutics, which AZN acquired in 2013. The successful outcomes of the PINNACLE studies are the first from a series of pipeline candidates using Pearl's technology.
    • PT003 was assessed in over 3,700 patients in over 275 study sites. The primary efficacy endpoint was trough forced expiratory volume in one second (FEV1). PT003 demonstrated statistically significant improvements in FEV1 versus placebo and the individual components glycopyrronium (PT001) and formoterol fumarate (PT005). PT001 and PT005 also showed statistically significant improvements in FEV1 compared to placebo.
    • The company plans to file regulatory applications beginning this year. It will present the study results at a scientific meeting later this year.
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  • Mon, Feb. 23, 4:35 PM
    • Theravance (NASDAQ:THRX) declares $0.25/share quarterly dividend, in line with previous.
    • Forward yield 5.72%
    • Payable March 31; for shareholders of record March 12; ex-div March 10.
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  • Thu, Feb. 19, 10:39 AM
    • Theravance (THRX +1.8%) Q4 results: Revenues: $7.3M (+386.7%); Operating Expense: $7.2M (-19.1%); Operating Income: $0.1M (+101.4%); Net Loss: ($15.9M) (-78.7%); Loss Per Share: ($0.14) (-75.0%).
    • FY2014 results: Revenues: $8.4M (+86.7%); Operating Expense: $42.4M (+27.3%); Operating Loss: ($33.9M) (-17.7%); Net Loss: ($73.5M) (-140.2%); Loss Per Share: ($0.66) (-120.0%); Quick Assets: $283.4M (-45.6%).
    • No guidance given.
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  • Wed, Feb. 18, 4:41 PM
    • Theravance (NASDAQ:THRX): Q4 EPS of -$0.14 beats by $0.01.
    • Revenue of $7.28M (+395.2% Y/Y) beats by $1.86M.
    • Press Release
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  • Wed, Feb. 18, 11:52 AM
    • Theravance (THRX) will report Q4 and full-year results today after the close. The conference call will begin at 5:00 pm ET.
    • Consensus views for Q4 and 2014 are losses per share of ($0.14) and ($1.36) on revenues of $5.4M and $21.4M, respectively.
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  • Tue, Feb. 17, 5:35 PM
  • Fri, Feb. 13, 5:36 PM
    • Top gainers, as of 5:15 p.m.: IRWD +5.9%. HK +5.0%. EGY +4.8%. CAG +4.3%. TTS +3.5%.
    • Top losers, as of 5:15 p.m.: PES -9.7%. LOGM -7.7%. HOS -7.2%. THRX -6.4%. BTU -6.3%.
  • Fri, Feb. 6, 10:06 AM
    • On March 19, the FDA's Pulmonary-Allergy Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will jointly discuss the supplemental New Drug Application (sNDA) for the expanded use of Breo Ellipta (fluticasone furoate and vilantrol dry powder for inhalation) for the once-daily treatment of asthma in patients at least 12 years old.
    • Breo Ellipta is currently approved for the once-daily treatment of the symptoms of chronic obstructive pulmonary disease (COPD). It is being jointly developed by GlaxoSmithKline (GSK +0.7%) and Theravance (THRX +0.2%).
  • Dec. 1, 2014, 9:05 AM
    • The Australian Pharmaceutical Benefits Scheme (PBS) approves the reimbursement of GlaxoSmithKline (NYSE:GSK) and Theravance's (NASDAQ:THRX) Anoro Ellipta (umeclidinium/vilantrol) for the maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). Reimbursement will begin December 1, 2014.
    • COPD afflicts ~530K Australians.
    • Previously: Anoro Ellipta cleared in Australia
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  • Nov. 24, 2014, 8:02 AM
    • The European Commission approves AstraZeneca's (NYSE:AZN) Duaklir Genuair (aclidium bromide/formoterol fumarate 340/12 mcg) for the maintenance bronchodilator treatment in adults with chronic obstructive pulmonary disease (COPD).
    • The product is a fixed dose combination of two approved long-acting bronchodilators with different mechanisms of action. Aclidium bromide is an anticholinergic or long-acting muscarinic antagonist that produces bronchodilation by inhibiting the muscarinic M3 receptor in the airway smooth muscle. Formoterol fumarate is a long-acting beta-agonist that stimulates the B2-receptors in the bronchial smooth muscle resulting in bronchodilation. Both are currently approved as stand-alone therapies for the maintenance treatment of COPD in the U.S. and Europe.
    • Genuair is a multi-dose pre-loaded dry powder inhaler that utilizes optical and acoustic signals to inform the patient that the correct dose has been delivered.
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  • Nov. 19, 2014, 8:32 AM
    • GlaxoSmithKline (NYSE:GSK) has finished recruiting 2,800 people with Chronic Obstructive Pulmonary Disease (COPD) living in Salford, England to participate in a one-year Phase 3 open-label study to explore the effectiveness of Relvar Ellipta (fluticasone furoate "FF"/vilanterol "VI" 100/25 mcg) compared to other COPD treatments when used in a broad group of people living and managing their COPD on a daily basis.
    • The Salford Lung Study is the first "real-world" study of its kind in the world for a medicine prior to approval, conducted in one geographic location and run by GSK in collaboration with local healthcare providers.
    • Traditionally, drugs are evaluated in carefully-controlled randomized controlled trials on specific patient populations. Frequently, these trials exclude patients with additional conditions, or co-morbidities, that could influence the outcome. There is a need for additional information to complement the results from randomized trials in order to better understand a drug's potential when used in under real world circumstances. The Salford Lung Study is designed to provide this information.
    • The primary endpoint of the Salford trial is the mean annual rate of moderate and severe exacerbations. The study should finish in late 2015 with the first results expected in 2016.
    • Related ticker: (NASDAQ:THRX)
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Company Description
Theravance Inc provides is a royalty management company engaged in maximizing the potential value of the respiratory assets.
Sector: Healthcare
Industry: Biotechnology
Country: United States