Delaware
(State or Other Jurisdiction of Incorporation)
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000-30319
(Commission File Number)
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94-3265960
(I.R.S. Employer Identification Number)
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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(d)
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Exhibits.
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Exhibit
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Description
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Press Release dated January 9, 2014
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THERAVANCE, INC.
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Date: January 9, 2014
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By:
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/s/ Michael W. Aguiar
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Michael W. Aguiar
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Chief Financial Officer
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PRESS
RELEASE
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PRESS
RELEASE
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For the relief of acute deterioration of COPD.
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For the treatment of asthma.
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Patients with severe hypersensitivity to milk proteins.
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For the treatment of acute episodes of bronchospasm, i.e., as rescue therapy.
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ANORO™ ELLIPTA™ is not indicated for the treatment of acute episodes of bronchospasm (i.e., as rescue therapy).
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ANORO™ ELLIPTA ™ should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of COPD. Patients should be instructed to discontinue regular use of short-acting bronchodilators and to use them only for acute respiratory symptoms.
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Exacerbations may occur during treatment.
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ANORO™ ELLIPTA™ should not be used in conjunction with other medicines containing a LABA or a long-acting muscarinic antagonist (LAMA).
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There have been no studies investigating the effect of ANORO™ ELLIPTA™ on the ability to perform tasks that require judgement, motor or cognitive skills.
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Anticholinergic Effects: Use with caution in patients with narrow-angle glaucoma or urinary retention.
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Cardiovascular effects: ANORO™ ELLIPTA™ should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, acute myocardial infarction, cardiac arrhythmias, and hypertension. Cardiovascular effects such as cardiac arrhythmias, may be seen after the administration of ANORO™ ELLIPTA™. Treatment may need to be discontinued. ANORO™ ELLIPTA™ was associated with a dose-dependent increase in heart rate and QTcF prolongation in healthy subjects receiving steady-state treatment.
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Endocrine and Metabolism: Use with caution in patients with convulsive disorders, thyrotoxicosis and patients who are unusually responsive to sympathomimetic amines. Use with caution in patients predisposed to low levels of serum potassium and diabetic patients.
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Respiratory: Treatment should be discontinued if paradoxical bronchospasm occurs and alternative therapy instituted if necessary.
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Hypersensitivity: As with all medications, immediate hypersensitivity reactions may occur after administration of ANORO™ ELLIPTA™.
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PRESS
RELEASE
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The use of ANORO™ ELLIPTA™ is not indicated for use in patients under 18 years of age.
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Use during pregnancy, labour and in breastfeeding women should only occur if the potential benefit justifies the potential risk.
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Drug interactions: Caution should be exercised when considering coadministration with inhibitors of cytochrome P450 3A4; sympathomimetic agents; beta-blocking agents; non potassium sparing diuretics; drugs known to prolong the QTc interval; monoamine oxidase inhibitors and tricyclic antidepressants; xanthine derivatives; oral corticosteroids. Avoid coadministration with other anticholinergics.
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The recommended dose is one inhalation of ANORO™ ELLIPTA™ 62.5/25 mcg once daily.
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No dosage adjustment is required in patients over 65 years of age, in patients with renal impairment, or in patients with mild or moderate hepatic impairment. ANORO™ ELLIPTA™ has not been studied in patients with severe hepatic impairment.
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PRESS
RELEASE
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GSK Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2012.
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