Key Developments: Theravance Inc (THRX.O)

THRX.O on Nasdaq

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31 Oct 2014
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Latest Key Developments (Source: Significant Developments)

Theravance Inc announces data published on Anoro Ellipta demonstrate improved lung function compared to Tiotropium
Friday, 17 Oct 2014 05:05am EDT 

Theravance Inc:Says it has published positive results from third lung function study comparing efficacy & safety of Anoro Ellipta (umeclidinium /vilanterol, UMEC/VI), combination long-acting muscarinic antagonist/ long-acting beta2-adrenergic agonist, with LAMA tiotropium, administered in HandiHaler inhaler.Says in this study UMEC/VI 62.5/25 mcg showed a statistically significant improvement of 112mL compared with tiotropium 18mcg for the primary endpoint measurement of lung function using trough forced expiratory volume in one second (FEV1) at the end of the treatment period (day 169).Says for the secondary endpoint measurement of lung function using weighted mean FEV1 0 - 6 hour, at the end of the treatment period (day 168) UMEC/VI 62.5/25mcg showed a statistically significant improvement of 105mL, (95% confidence interval (CI) 71, 140, p < 0.001) compared to tiotropium 18 mcg.Says this study was a 24-week, blinded, parallel group, multicenter study to assess the efficacy and safety of UMEC/VI 62.5/25mcg inhalation powder administered once-daily in the dry powder inhaler, Ellipta, compared to tiotropium 18mcg administered once-daily in the HandiHaler inhaler.  Full Article

Theravance Inc appoints Eric d'Esparbes as Senior Vice President and Chief Financial Officer
Thursday, 9 Oct 2014 04:05pm EDT 

Theravance Inc:Announced the appointment of Eric d'Esparbes as Senior Vice President and Chief Financial Officer.  Full Article

Theravance Inc declares dividend for third quarter
Wednesday, 6 Aug 2014 04:08pm EDT 

Theravance Inc:Declares $0.25 per share dividend for third quarter of 2014.Dividend will be paid on Sept. 18, 2014 to all stockholders of record as of close of business on Aug. 28, 2014.  Full Article

Theravance Inc appoints Michael W. Aguiar as president and chief executive officer
Wednesday, 6 Aug 2014 04:05pm EDT 

Theravance Inc:Appoints Michael W. Aguiar as President and Chief Executive Officer of the company effective Aug. 15, 2014 and as a member of the Board of Directors effective immediately.  Full Article

Theravance Inc and GlaxoSmithKline plc announce initiation of Phase III programme
Wednesday, 16 Jul 2014 02:25am EDT 

Theravance Inc and GlaxoSmithKline plc:Says the start of a global phase III study, known as IMPACT, to evaluate the efficacy and safety of the 'closed' triple combination of FF/UMEC/VI in patients with chronic obstructive pulmonary disease (COPD).IMPACT is a pivotal phase III study to evaluate a once-daily closed triple combination treatment of an inhaled corticosteroid (ICS) a long-acting muscarinic antagonist (LAMA); and a long-acting beta2-adrenergic agonist (LABA) in patients with COPD.  Full Article

GlaxoSmithKline plc and Theravance Inc announces Anoro Ellipta (Umeclidinium/Vilanterol) Gains Approval in Japan for treatment of COPD
Monday, 7 Jul 2014 08:00am EDT 

GlaxoSmithKline plc and Theravance Inc:Says Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Anoro Ellipta (umeclidinium/vilanterol) for relief of various symptoms due to airway obstruction with chronic obstructive pulmonary diseases (chronic bronchitis, pulmonary emphysema).Says in case where concurrent use of long-acting inhaled muscarinic antagonist and long-acting inhaled beta2 agonist is required.Says Anoro is once-daily combination treatment comprised of two bronchodilators, umeclidinium (UMEC), a long-acting muscarinic antagonist (LAMA), and vilanterol (VI), a long-acting beta2 agonist (LABA), in a single inhaler, the Ellipta.Approved dose in Japan is UMEC/VI 62.5/25mcg delivered once daily.Under the terms of the 2002 LABA collaboration agreement, Theravance is obligated to make payment of $10 mln to GSK following MHLW approval of UMEC/VI in Japan.  Full Article

GlaxoSmithKline Plc and Theravance Inc announces submission to US Regulatory Authorities for Fluticasone Furoate/Vilanterol in Asthma
Monday, 30 Jun 2014 08:07am EDT 

GlaxoSmithKline Plc and Theravance Inc:Announces submission of supplemental New Drug Application (sNDA) to US Food and Drug Administration (FDA).Says for fixed dose combination of the inhaled corticosteroid, fluticasone furoate and the long-acting beta2 agonist, vilanterol (FF/VI) as once-daily treatment for asthma in patients aged 12 years and older, with brand name of Breo Ellipta.SNDA is seeking approval for two dose regimens, 100/25mcg and 200/25mcg, administered once daily using the Ellipta dry powder inhaler.Filing is based upon data generated from the comprehensive clinical development programme for FF/VI in asthma.Says clinical development programme comprised 48 clinical pharmacology studies in 1,328 subjects and 23 clinical studies in 12,051 patients with asthma, including the Phase III efficacy and safety study of FF/VI reported in Dec. 2013.  Full Article

GlaxoSmithKline Plc and Theravance Inc announces positive results from two phase III studies
Wednesday, 11 Jun 2014 07:30am EDT 

GlaxoSmithKline Plc and Theravance Inc:Positive results from two phase III studies, which showed that patients with chronic obstructive pulmonary disease (COPD) who received the anticholinergic, Incruse(tm) Ellipta (umeclidinium (UMEC) 62.5mcg), or umeclidinium 125mcg (an unlicensed dose).Says in addition to Relvar/Breo Ellipta an inhaled corticosteroid / long-acting beta2-agonist combination.Says achieved an additional improvement in lung function (FEV1) compared to patients receiving FF/VI plus placebo.Studies showed that for the primary endpoint of trough FEV1 at Day 85, the addition of UMEC 62.5mcg or UMEC 125mcg to FF/VI 100/25mcg resulted in a statistically improvement in lung function when compared with FF/VI 100/25mcg plus placebo in patients with COPD.  Full Article

Theravance Inc and Theravance Biopharma Inc announce completion of separation of late-stage partnered respiratory assets from biopharmaceutical operations
Monday, 2 Jun 2014 08:05pm EDT 

Theravance Inc and Theravance Biopharma Inc:Say completion of separation of Theravance Biopharma Inc, research and development-based biopharmaceutical business, from Theravance Inc to form two, independent, publicly traded companies with differing business objectives and opportunities.Separation is achieved via a dividend distribution of Theravance Biopharma shares to Theravance stockholders.  Full Article

Glaxosmithkline Plc and Theravance Inc announce Anoro (Umeclidinium/Vilanterol) gains marketing authorisation in Europe for the treatment of COPD
Thursday, 8 May 2014 11:12am EDT 

Glaxosmithkline Plc and Theravance Inc:Says the European Commission has granted marketing authorisation for Anoro (umeclidinium/vilanterol) as a once-daily, maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).Under the terms of the 2002 LABA collaboration agreement, Theravance is obligated to make a milestone payment to GSK of $15 mln following marketing authorisation for UMEC/VI by the European Commission.A further $15 mln payment to GSK will follow the launch of UMEC/VI in Europe.First launch is expected to take place in Europe in Q2-3 2014 with additional launches to follow thereafter.  Full Article

BRIEF-GSK and Theravance says gains approval in Japan for Anoro Ellipta

* Press_release:anoro ellipta(umeclidinium/vilant erol) gains approval in Japan for the treatment of COPD

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