Theravance study results confirm in vitro potency of VIBATIV

by | May 10, 2014 | COPD in the News | 0 comments

News Breaks
May 9, 2014
18:05 EDT THRX Theravance study results confirm in vitro potency of VIBATIV
Theravance announced new data from multiple studies of VIBATIV. These study results, which offer new insight into the product’s in vitro potency, efficacy and safety, will be the focus of multiple presentations over the next several days at the 24th European Congress of Clinical Microbiology and Infectious Diseases in Barcelona, Spain. Combined, the data presentations confirm the in vitro potency of VIBATIV and its efficacy in patients with complicated skin and skin structure infections including methicillin-resistant Staphylococcus aureus.

News For THRX From The Last 14 Days

Check below for free stories on THRX the last two weeks.
May 9, 2014
18:05 EDT THRX Theravance study results confirm in vitro potency of VIBATIV
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May 8, 2014
11:21 EDT THRX Glaxo, Theravance granted marketing authorization for Anoro in COPD in Europe
GlaxoSmithKline (GSK) and Theravance (THRX) announced that the European Commission has granted marketing authorization for Anoro as a once-daily, maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease, or COPD. Anoro is a once-daily combination treatment comprising two bronchodilators, umeclidinium, a long-acting muscarinic antagonist, and vilanterol, a long-acting beta2 agonist, in a single inhaler, the Ellipta. The licensed strength in Europe is UMEC/VI 55mcg / 22mcg. Under the terms of the 2002 LABA collaboration agreement, Theravance is obligated to make a milestone payment to GSK of $15M following marketing authorization for UMEC/VI by the European Commission. A further $15M payment to GSK will follow the launch of UMEC/VI in Europe. The first launch is expected to take place in Europe in Q2-Q3, with additional launches to follow thereafter.
May 6, 2014
16:45 EDT THRX Theravance announces May 15 record date, June 2 share issue date for separation
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April 30, 2014
16:50 EDT THRX Theravance announces positive results from a Phase 2 study of TD-9855
Theravance announced positive results from a Phase 2 study of TD-9855, an investigational norepinephrine and serotonin reuptake inhibitor, or NSRI, in patients with fibromyalgia, or FM. The study demonstrated statistically significant and clinically meaningful improvements in the primary and secondary endpoints at the 20 mg dose of TD-9855 compared to placebo. The 5 mg dose did not meet statistical significance for the primary endpoint. Both doses were generally well tolerated. The primary efficacy endpoint of the Phase 2 study was the average of the daily pain score during the last week of the 6-week treatment period, using an 11-point Numerical Rating Scale. Pre-specified secondary endpoints were the Fibromyalgia Impact Questionnaire and the Patient Global Impression of Change scale measured on Day 43. Three hundred ninety-two patients were randomized to one of three treatment groups: placebo, 5 mg and 20 mg TD-9855. Both doses of TD-9855 were generally well tolerated in the study. The discontinuation rate in this trial was 20.2%, and was similar across treatment groups. The five most common treatment-emergent adverse events reported were headache, nausea, dizziness, insomnia and constipation. Changes in heart rate and blood pressure with TD-9855 were within the range of those seen in approved drugs in this class. Two serious adverse events were reported in TD-9855 treatment groups, with one assessed as possibly treatment related in the 5 mg group.
April 28, 2014
08:17 EDT THRX GSK, Theravance announce Anoro Ellipta available in U.S. for treatment of COPD
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