<SEC-DOCUMENT>0001102624-12-001007.txt : 20121218
<SEC-HEADER>0001102624-12-001007.hdr.sgml : 20121218
<ACCEPTANCE-DATETIME>20121218075140
ACCESSION NUMBER:		0001102624-12-001007
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20121218
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20121218
DATE AS OF CHANGE:		20121218

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:		121270021

	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
<SEQUENCE>1
<FILENAME>theravanceinc8k.htm
<DESCRIPTION>THERAVANCE, INC. 8-K
<TEXT>
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<B>UNITED STATES</B><br>
<B>SECURITIES AND EXCHANGE COMMISSION</B><br>
Washington, D.C. 20549<p>
<hr size=1>
<p><b>FORM 8-K<p>
CURRENT REPORT
<p>
Pursuant to Section 13 or 15(d) of the<br>Securities Exchange Act of 1934
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<b>Date of Report: December  18, 2012</b><br>
(Date of earliest event reported)<br><br>
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<b>Theravance, Inc.</b><br>
(Exact name of registrant as specified in its charter)
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<b>Delaware</b><br>
(State or other jurisdiction <br>of incorporation)
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<b>000-30319</b><br>
(Commission File Number)
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<b>94-3265960</b><br>
(IRS Employer <br>Identification Number)
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<b>901 Gateway Boulevard, South San Francisco, CA</b><br>
(Address of principal executive offices)
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<td>&nbsp;</td>
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<b>94080</b><br>
(Zip Code)
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<b>650-808-6000</b><br>(Registrant's telephone number, including area code)
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<b>Not Applicable</b><br>(Former Name or Former Address, if changed since last report)<br>
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</b>
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:<br>
<dl>
 <dd><font face="wingdings">o</font> Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)<br>
 <dd><font face="wingdings">o</font> Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)<br>
 <dd><font face="wingdings">o</font> Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

  <br>
 <dd><font face="wingdings">o</font> Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

  <br>
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<b>Item 8.01. Other Events</b></b><br>
<br>
On December 18, 2012, GlaxoSmithKline plc (GSK) and Theravance, Inc. (the "Company") issued a press release announcing that a New Drug Application (NDA) for UMEC/VI with the proposed proprietary name ANORO ELLIPTA(TM) has been submitted to the U.S. Food and Drug Administration (FDA), for the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.  UMEC/VI is a combination of two investigational bronchodilator molecules - GSK573719 or umeclidinium bromide (UMEC), a long-acting muscarinic antagonist and vilanterol (VI), a long-acting beta2 agonist (LABA), administered using the ELLIPTA(TM) inhaler.  UMEC/VI is currently in development under the LABA collaboration between GSK and the Company.   A copy of the press release is filed as Exhibit 99.1 to this report and is incorporated herein by reference.
<p>
<b>Item 9.01. Financial Statements and Exhibits</b></b><br />
<br>

<p>
<b>(d) Exhibits</b><br>
&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;  99.1 &nbsp; &nbsp; &nbsp; <a href="theravanceinc.htm">Press Release of Theravance, Inc. dated December  18, 2012</a></b>
<br>
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<b><center>SIGNATURE</center></b>
<p>
&nbsp; &nbsp; &nbsp; Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be
              signed on its behalf by the undersigned hereunto duly authorized.<p>
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Dated: December  18, 2012<br>
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<b>THERAVANCE, INC.</b>
<p>
By: <u>&nbsp;/s/ Michael W. Aguiar &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; </u> <br>
&nbsp; &nbsp; &nbsp;Michael W. Aguiar<br>
&nbsp; &nbsp; &nbsp;<i>Chief Financial Officer </i><br>
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<center><b>Exhibit Index</b></center>
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<td width=50% align=center><b><u>Exhibit No.</u></b></td>
<td width=50% align=center><b><u>Description</u></b></td>
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<td align=center>99.1</td>
<td align=center>Press Release of Theravance, Inc. dated December  18, 2012</td>
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<DOCUMENT>
<TYPE>EX-99
<SEQUENCE>2
<FILENAME>theravanceinc.htm
<DESCRIPTION>THERAVANCE, INC. PRESS RELEASE
<TEXT>

<p></p>
<b>GSK and Theravance Announce Regulatory Submission for UMEC/VI (LAMA/LABA) in the US </b>
<p>ANORO ELLIPTA(TM) Proposed Proprietary Name for UMEC/VI</p>
<p>LONDON and SOUTH SAN FRANCISCO, CA -- (Marketwire - December  18, 2012) -  GlaxoSmithKline plc (GSK) and Theravance, Inc. (NASDAQ: THRX) today announced the submission of a regulatory application in the US for the investigational once-daily LAMA/LABA combination medicine, UMEC/VI, for patients with chronic obstructive pulmonary disease (COPD).
</p>
<p>
UMEC/VI is a combination of two investigational bronchodilator molecules -- GSK573719 or umeclidinium bromide (UMEC), a long-acting muscarinic antagonist (LAMA) and vilanterol (VI), a long-acting beta2 agonist (LABA), administered using the ELLIPTA&#8482; inhaler.
</p>
<p>
<b>US Submission:<br>
</b>A New Drug Application (NDA) for UMEC/VI (62.5/25mcg and 125/25mcg doses) with the proposed proprietary name ANORO ELLIPTA&#8482; has been submitted to the US Food and Drug Administration (FDA), for the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema.
</p>
<p>
<b>Future Regulatory Submissions: <br>
</b>Regulatory filings for UMEC/VI are planned in the European Union imminently and in other countries during the course of 2013. In addition, GSK intends to commence global regulatory submissions for UMEC monotherapy in the ELLIPTA&#8482; inhaler for COPD patients in 2013.
</p>
<p>
<b>Other Respiratory Development Programmes:<br>
</b>UMEC/VI is one of several late-stage assets in the GSK respiratory development portfolio, which includes fluticasone furoate/vilanterol (FF/VI, with proposed brand names RELVAR&#8482; and BREO&#8482;), VI monotherapy and MABA (GSK961081), developed in collaboration with Theravance, as well as GSK's investigational medicines FF monotherapy, UMEC monotherapy and anti-IL5 MAb (mepolizumab). These investigational medicines are not currently approved anywhere in the world.
</p>
<p>
ANORO&#8482;, RELVAR&#8482;, BREO&#8482; and ELLIPTA&#8482; are trademarks of the GlaxoSmithKline group of companies. The use of these brand names is not approved by any regulatory authority.
</p>
<p>
<b>GlaxoSmithKline</b> -- one of the world's leading research-based pharmaceutical and healthcare companies -- is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.
</p>
<p>
<b>Theravance</b> -- 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&#8482; or BREO&#8482; (FF/VI), ANORO&#8482; (UMEC/VI) and MABA (Bifunctional Muscarinic Antagonist-Beta2 Agonist), each partnered with GlaxoSmithKline plc, and its oral Peripheral Mu Opioid Receptor Antagonist program. 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's web site at www.theravance.com.
</p>
<p>
THERAVANCE&#174;, the Theravance logo, and MEDICINES THAT MAKE A DIFFERENCE&#174; are registered trademarks of Theravance, Inc.
</p>
<p>
<b>GlaxoSmithKline cautionary statement regarding forward-looking statements<br>
</b>Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, 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 'Risk factors' in the 'Financial review &amp; risk' section in the company's Annual Report 2011 included as exhibit 15.2 to the company's Annual Report on Form 20-F for 2011.
</p>
<p>
<b>Theravance forward-looking statements<br>
</b>This press release contains certain "forward-looking" statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives and future events. Theravance intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements relating to statements regarding the potential benefits and mechanisms of action of drug candidates, statements concerning the timing of seeking regulatory approval of our product candidates, statements concerning the enabling capabilities of Theravance's approach to drug discovery and its proprietary insights and statements concerning expectations for product candidates through development and commercialization. These statements are based on the current estimates and assumptions of the management of Theravance as of the date of this press release and are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Theravance to be materially different from those reflected in its forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, the potential that results of clinical or non-clinical studies indicate product candidates are unsafe or ineffective, delays or failure to achieve regulatory approvals for product candidates, risks of relying on third-party manufacturers for the supply of our product and product candidates and risks of collaborating with third parties to develop and commercialize products. These and other risks are described in greater detail under the heading "Risk Factors" contained in Theravance's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on October 31, 2012 and the risks discussed in our other period filings with SEC. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Theravance assumes no obligation to update its forward-looking statements.

</p>
<pre>
<b>GlaxoSmithKline Enquiries:</b>

UK Media enquiries:
David Mawdsley
+44 (0) 20 8047 5502
(London)

Sarah Spencer
+44 (0) 20 8047 5502
(London)

David Daley
+44 (0) 20 8047 5502
(London)

Catherine Hartley
+44 (0) 20 8047 5502
(London)

Alex Harrison
+44 (0) 20 8047 5502
(London)

US Media enquiries:
Stephen Rea
+1 215 751 4394
(Philadelphia)

Mary Rhyne
+1 919 483 0492
(North Carolina)

Sarah Alspach
+1 202 715 1048
(Washington, DC)

Analyst/Investor enquiries:
Sally Ferguson
+44 (0) 20 8047 5543
(London)

Lucy Budd
+44 (0) 20 8047 2248
(London)

Tom Curry
+1 215 751 5419
(Philadelphia)

Gary Davies
+44 (0) 20 8047 5503
(London)

James Dodwell
+44 (0) 20 8047 2406
(London)

Jeff McLaughlin
+1 215 751 7002
(Philadelphia)

Ziba Shamsi
+ 44 (0) 20 8047 3289
(London)

<b>Theravance, Inc. Enquiries:
</b>Michael W. Aguiar
+1 650 808 4100
Investor.relations@theravance.com</a>
(San Francisco)


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