<SEC-DOCUMENT>0001102624-14-000607.txt : 20140422
<SEC-HEADER>0001102624-14-000607.hdr.sgml : 20140422
<ACCEPTANCE-DATETIME>20140422060501
ACCESSION NUMBER:		0001102624-14-000607
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		4
CONFORMED PERIOD OF REPORT:	20140422
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20140422
DATE AS OF CHANGE:		20140422

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			THERAVANCE INC
		CENTRAL INDEX KEY:			0001080014
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				943265960
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	000-30319
		FILM NUMBER:		14775193

	BUSINESS ADDRESS:	
		STREET 1:		901 GATEWAY BLVD
		CITY:			SOUTH SAN FRANCISCO
		STATE:			CA
		ZIP:			94080
		BUSINESS PHONE:		6508086000

	MAIL ADDRESS:	
		STREET 1:		901 GATEWAY BLVD
		CITY:			S. SAN FRANCISCO
		STATE:			CA
		ZIP:			94080

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	ADVANCED MEDICINE INC
		DATE OF NAME CHANGE:	20000302
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
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<FILENAME>theravance8k.htm
<DESCRIPTION>COVER SHEET
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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Date of Report (Date of earliest event Reported):&#160;&#160;April 22, 2014</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">On April 22, 2014, GlaxoSmithKline plc and Theravance, Inc. issued a press release announcing that the Therapeutic Goods Administration (TGA) has approved BREO&#8482; ELLIPTA<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top">&#174;</font> (fluticasone furoate/vilanterol trifenatate) for the treatment of patients with asthma or chronic obstructive pulmonary disease (COPD) in Australia.&#160;&#160;BREO&#8482; ELLIPTA<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top">&#174; </font>is a combination of the inhaled corticosteroid, fluticasone furoate (FF), and the long-acting beta<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: sub">2</font>-agonist (LABA), vilanterol (VI). Two strengths of BREO&#8482; ELLIPTA<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top">&#174;</font> have been licensed for the treatment of asthma (100/25 mcg and 200/25 mcg) and one strength has been licensed for the treatment of COPD (100/25 mcg).&#160;&#160;Both strengths will be administered once-daily using the new ELLIPTA<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top">&#174;</font> dry powder inhaler.&#160;&#160;FF/VI has been developed under the 2002 LABA collaboration between Glaxo Group Limited and Theravance, Inc.&#160;&#160;The press release is filed as Exhibit 99.1 to this report and is incorporated herein by reference.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 19.05pt" align="center"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 12pt"><font style="DISPLAY: inline; FONT-WEIGHT: bold">Breo</font><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top; FONT-WEIGHT: bold">&#8482;</font><font style="DISPLAY: inline; FONT-WEIGHT: bold">Ellipta</font><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top; FONT-WEIGHT: bold">&#174; </font><font style="DISPLAY: inline; FONT-WEIGHT: bold">(fluticasone furoate/vilanterol trifenatate)</font><font style="DISPLAY: inline; FONT-SIZE: 10pt">&#160;</font><font style="DISPLAY: inline; FONT-WEIGHT: bold">approved in Australia for Asthma and Chronic Obstructive Pulmonary Disease</font></font></font></div>

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<div align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt"><font style="DISPLAY: inline; FONT-WEIGHT: bold">Fir</font><font style="DISPLAY: inline; FONT-WEIGHT: bold">s</font><font style="DISPLAY: inline; FONT-WEIGHT: bold">t combination of an inhaled corticosteroid and a long-acting beta</font><font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: sub; FONT-WEIGHT: bold">2</font><font style="DISPLAY: inline; FONT-WEIGHT: bold">-agonist administered once daily</font><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top; FONT-WEIGHT: bold">1</font></font></div>
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<div align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt"><font style="DISPLAY: inline; FONT-WEIGHT: bold">Administered using a new dry powder inhaler called Ellipta</font><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top; FONT-WEIGHT: bold">1</font></font></div>
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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 9pt; MARGIN-RIGHT: 19.9pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold"><font style="DISPLAY: inline; FONT-FAMILY: times new roman; FONT-SIZE: 10pt; FONT-WEIGHT: normal">GSK Australia and Theravance, Inc. (NASDAQ:&#160;&#160;THRX) announced today that the Therapeutic Goods Administration (TGA) has approved Breo Ellipta for the treatment of patients with asthma or chronic obstructive pulmonary disease (COPD) in Australia<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top; FONT-WEIGHT: normal">1</font>.</font></font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 9pt; MARGIN-RIGHT: 19.9pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold"><font style="DISPLAY: inline; FONT-FAMILY: times new roman; FONT-SIZE: 10pt; FONT-WEIGHT: normal">Breo Ellipta is a combination of the inhaled corticosteroid (ICS), fluticasone furoate (FF), and the long-acting beta<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: sub; FONT-WEIGHT: normal">2</font>-agonist (LABA), vilanterol (VI). Two strengths of Breo Ellipta have been licensed for the treatment of asthma (100/25 mcg and 200/25 mcg) and one strength has been licensed for the treatment of COPD (100/25 mcg)<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top; FONT-WEIGHT: normal">1</font>.</font></font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 9pt; MARGIN-RIGHT: 19.9pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt"><font style="FONT-WEIGHT: normal">Both strengths will be administered once-daily using the new Ellipta dry powder inhaler<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top; FONT-WEIGHT: normal">1</font><font style="DISPLAY: inline; FONT-FAMILY: times new roman; FONT-WEIGHT: normal">.</font></font></font></font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 9pt; MARGIN-RIGHT: 19.9pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold"><font style="DISPLAY: inline; FONT-FAMILY: times new roman; FONT-SIZE: 10pt; FONT-WEIGHT: normal">Respiratory specialist Professor Grant Waterer welcomed the new registration saying the availability of a once-daily corticosteroid with a once-daily long acting beta-agonist in the same inhaler is an exciting development for patients and their doctors.</font></font></div>

<div style="TEXT-INDENT: 0pt; DISPLAY: block"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold">&#160;</font></div>

<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 9pt; MARGIN-RIGHT: 19.9pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold"><font style="DISPLAY: inline; FONT-FAMILY: times new roman; FONT-SIZE: 10pt; FONT-WEIGHT: normal">&#8220;In both COPD and asthma there is significant potential to improve patient outcomes especially where compliance with twice daily regimens has been problematic,&#8221; said Professor Waterer.</font></font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 9pt; MARGIN-RIGHT: 19.9pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold"><font style="DISPLAY: inline; FONT-FAMILY: times new roman; FONT-SIZE: 10pt; FONT-WEIGHT: normal">GSK Medical Director Dr Andrew Yeates says the company had been focused for many years on the development of new treatments for patients with asthma or COPD.</font></font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 9pt; MARGIN-RIGHT: 19.9pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold"><font style="DISPLAY: inline; FONT-FAMILY: times new roman; FONT-SIZE: 10pt; FONT-WEIGHT: normal">&#8220;We are delighted that Breo Ellipta is now approved in Australia. GSK is committed to supporting innovation in respiratory medicine and has a strong pipeline of products which will help us to deliver this to our Australian patients. We are proud that healthcare professionals in Australia will<font style="DISPLAY: inline; FONT-FAMILY: times new roman; FONT-WEIGHT: normal">,</font> for the first time, have the option of prescribing an effective once daily ICS/LABA combination which is delivered in our new Ellipta inhaler device,<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top; FONT-WEIGHT: normal">1</font>&#8221; said Dr Yeates.</font></font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 9pt; MARGIN-RIGHT: 19.9pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold"><font style="DISPLAY: inline; FONT-FAMILY: times new roman; FONT-SIZE: 10pt; FONT-WEIGHT: normal">&#8220;The Australian approval of Breo Ellipta is yet another important achievement and is testament to our successful partnership with GSK in respiratory disease,&#8221; said Rick E Winningham, Chief Executive Officer of Theravance. &#8220;We are delighted that the TGA has approved Breo Ellipta for the treatment of asthma and COPD and look forward to seeing the benefits of this effective once-daily treatment option in these patient populations.&#8221;</font></font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 9pt; MARGIN-RIGHT: 19.9pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold"><font style="DISPLAY: inline; FONT-FAMILY: times new roman; FONT-SIZE: 10pt; FONT-WEIGHT: normal">It is estimated that approximately 10% of Australians have asthma<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top; FONT-WEIGHT: normal">2</font>.</font></font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 9pt; MARGIN-RIGHT: 19.9pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold">About Breo Ellipta<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top">1</font></font></font></div>

<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 9pt; MARGIN-RIGHT: 19.9pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt"><font style="FONT-WEIGHT: normal">Breo Ellipta is registered for use in the regular treatment of moderate to severe asthma and in the symptomatic treatment of COPD where the FEV<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: sub; FONT-WEIGHT: normal">1</font> &lt;70% predicted normal (post-bronchodilator) and there is a history of exacerbations despite regular bronchodilator therapy.<font style="DISPLAY: inline; FONT-FAMILY: times new roman; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top; FONT-WEIGHT: normal">1</font></font></font></font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 9pt; MARGIN-RIGHT: 19.9pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold"><font style="DISPLAY: inline; FONT-FAMILY: times new roman; FONT-SIZE: 10pt; FONT-WEIGHT: normal">Following TGA registration GSK&#8217;s next focus is to make Breo Ellipta available to prescribers.</font></font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 9pt; MARGIN-RIGHT: 19.9pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt"><font style="FONT-WEIGHT: normal">Breo Ellipta was well tolerated in clinical trials.&#160;&#160;As with all ICS therapy, patients should rinse their mouth with water after use to minimise the local adverse effects.&#160;&#160;To minimise adverse reactions, ICS should be used at the lowest dose that maintains symptom control.<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top; FONT-WEIGHT: normal">1</font></font></font></font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 9pt; MARGIN-RIGHT: 19.9pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt"><font style="FONT-WEIGHT: normal">Adverse events included; headache, nasopharyngitis, URTI, bronchitis, oropharyngeal, pain, cough, sinusitis, back pain, influenza, pharyngitis, dysphonia, rhinitis allergic, abdominal pain upper pyrexia, oral candidiasis, extrasystoles, nasopharyngitis, fractures.&#160;&#160;Pneumonia has been reported in patients with COPD.<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top; FONT-WEIGHT: normal">1</font></font></font></font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 9pt; MARGIN-RIGHT: 19.9pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold"><font style="DISPLAY: inline; FONT-FAMILY: times new roman; FONT-SIZE: 10pt; FONT-WEIGHT: normal">Professor Grant Waterer has served on advisory boards and been involved in clinical trials sponsored by GSK for which compensation was received. In relation to this GSK media announcement, no compensation was provided to Professor Grant Waterer, and the opinions expressed are their own. Dr Grant Waterer has been briefed by GSK on the approved use of this product.</font></font></div>

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<div style="TEXT-INDENT: 0pt; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Breo<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top">&#8482;</font> Ellipta<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top">&#174;</font> Product information, 17 April 2014</font></div>
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<div style="TEXT-INDENT: 0pt; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">National Health survey 2007-8; adults. Prevalence in adults stable (AIHW: Asthma in Australia 2011; COPD in Australia&#160;&#160;p14; p164)</font></div>
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<div style="TEXT-ALIGN: center"><font size="2" style="FONT-WEIGHT: bold">PBS Information &#8211; This product is not listed on the PBS</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt"><font style="DISPLAY: inline; FONT-WEIGHT: bold">Indications:</font><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman"> <font style="FONT-WEIGHT: normal">Asthma: Regular treatment of moderate to severe asthma in patients requiring medium to high dose inhaled corticosteroid combined with long acting &#946;</font></font><font style="FONT-WEIGHT: normal"><font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: sub; FONT-WEIGHT: normal">2</font>-agonist.&#160;&#160;COPD: symptomatic treatment of patients with COPD with a FEV<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: sub; FONT-WEIGHT: normal">1</font> &lt;70% predicted normal (post-bronchodilator) in patients with an exacerbation history despite regular bronchodilator therapy. Breo<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top; FONT-WEIGHT: normal">&#8482;</font> Ellipta<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top; FONT-WEIGHT: normal">&#174;</font><font style="DISPLAY: inline; FONT-WEIGHT: normal">&#160;</font>is not indicated for the initiation of bronchodilator therapy in COPD.</font></font></font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt"><font style="DISPLAY: inline; FONT-WEIGHT: bold">Dosage:</font> <font style="FONT-WEIGHT: normal">Prescribers should be aware that 100 mcg of fluticasone furoate is a medium dose of inhaled corticosteroid and 200 mcg of fluticasone furoate is a high dose of inhaled corticosteroid.&#160;&#160;&#160;Asthma: (Adults and Adolescents &#8805; 12 years): 1 inhalation once daily (100/25mcg or 200/25mcg). In patients whose asthma is well controlled and stable the Breo<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top; FONT-WEIGHT: normal">&#8482;</font> Ellipta<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top; FONT-WEIGHT: normal">&#174;</font> dose may carefully be down-titrated to the lowest strength of Breo<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top; FONT-WEIGHT: normal">&#8482;</font> Ellipta<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top; FONT-WEIGHT: normal">&#174;</font>.&#160;&#160;The next step should consider the cessation of Breo<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top; FONT-WEIGHT: normal">&#8482;</font> Ellipta<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top; FONT-WEIGHT: normal">&#174;</font> and transfer to an appropriate inhaled corticosteroid containing regimen. COPD: 1 inhalation once daily (100/25mcg only).&#160;&#160;&#160;Breo<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top; FONT-WEIGHT: normal">&#8482;</font> Ellipta<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top; FONT-WEIGHT: normal">&#174;</font> 200/25 mcg is not indicated for patients with COPD<font style="DISPLAY: inline; FONT-WEIGHT: normal">. </font>&#160;&#160;Specific patient population: Elderly patients: due to limited data in patients with asthma aged 75 years and older, Breo<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top; FONT-WEIGHT: normal">&#8482;</font> Ellipta<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top; FONT-WEIGHT: normal">&#174;</font> 200/25mcg is not recommended.&#160;&#160;&#160;Moderate to Severe Hepatic Impairment: once daily maximum dose of 100/25mcg.</font></font></font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 7.95pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt"><font style="DISPLAY: inline; FONT-WEIGHT: bold">Theravance </font>&#8211; <font style="FONT-WEIGHT: normal">is a biopharmaceutical company with a pipeline of internally discovered product candidates and strategic collaborations with pharmaceutical companies. Theravance is focused on the discovery, development and commercialization of small molecule medicines across a number of therapeutic areas including respiratory disease, bacterial infections, and central nervous system (CNS)/pain. Theravance's key programs include: RELVAR<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top; FONT-WEIGHT: normal">&#174;</font>/BREO<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top; FONT-WEIGHT: normal">&#174;</font> ELLIPTA<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top; FONT-WEIGHT: normal">&#174;</font> (FF/VI), ANORO&#8482; ELLIPTA&#8482; (UMEC/VI) and MABA (Bifunctional Muscarinic Antagonist-Beta<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: sub; FONT-WEIGHT: normal">2</font> Agonist) GSK961081, each partnered with GlaxoSmithKline plc (GSK), and its Long-Acting Muscarinic Antagonist program.&#160;&#160;By leveraging its proprietary insight of multivalency to drug discovery, Theravance is pursuing a best-in-class strategy designed to discover superior medicines in areas of significant unmet medical need. For more information, please visit Theravance&#8217;s web site at www.theravance.com.</font></font></font></div>

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