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<SEC-DOCUMENT>0001102624-08-000324.txt : 20081119
<SEC-HEADER>0001102624-08-000324.hdr.sgml : 20081119
<ACCEPTANCE-DATETIME>20081119150240
ACCESSION NUMBER:		0001102624-08-000324
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20081119
ITEM INFORMATION:		Regulation FD Disclosure
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20081119
DATE AS OF CHANGE:		20081119

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:		081200764

	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>theravance8k.htm
<DESCRIPTION>THERAVANCE, INC. 8-K
<TEXT>
<table cellpadding="3" border="0" cellspacing="0" width="100%">
<tr><td>
</td></tr>
</table>
<center>
<table border=0 cellpadding=3 cellspacing=0>
<tr><td align="center"><br><br>
<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.
</td>
</tr>
</table>
<p>
<b>
<table border=0 cellpadding=0 cellspacing=0>
<tr><td colspan=5 align=center>
<b>Date of Report: November  19, 2008</b><br>
(Date of earliest event reported)<br><br>
</td></tr>
<tr><td colspan=5 align=center>
<b>Theravance, Inc.</b><br>
(Exact name of registrant as specified in its charter)
</td></tr>
<tr><td colspan=5><br></td></tr>
<tr>
<td align=center colspan=2 width="40%" valign="top">
<b>Delaware</b><br>
(State or other jurisdiction <br>of incorporation)
</td>
<td align=center width="20%" valign="top">
<b>000-30319</b><br>
(Commission File Number)
</td>
<td align=center colspan=2 width="40%" valign="top">
<b>94-3265960</b><br>
(IRS Employer <br>Identification Number)
</td>
</tr>
<tr><td colspan=5><br></td></tr>
<tr>
<td align="center" colspan=2>
<b>901 Gateway Boulevard, South San Francisco, CA</b><br>
(Address of principal executive offices)
</td>
<td>&nbsp;</td>
<td align="center" colspan=2>
<b>94080</b><br>
(Zip Code)
</td>
</tr>
<tr><td colspan=5 align=center><br>
<b>650-808-6000</b><br>(Registrant's telephone number, including area code)
</td></tr>
<tr><td colspan=5><br></td></tr>
<tr><td colspan=5 align=center>
<b>Not Applicable</b><br>(Former Name or Former Address, if changed since last report)<br>
</td></tr>
</table>
</center>
<br><br>
</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>
</dl>
<hr size=1>
<table width=100%>
<tr><td width="100%">
<b>Item 7.01. Regulation FD Disclosure</b></b><br>
<br>
The information in this Current Report (including Exhibit 99.1) is being furnished and shall not be deemed "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section. The information in this Current Report (including Exhibit 99.1) shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.
<br>
<br>Today Theravance, Inc. issued a press release announcing the outcome of the meeting of the Anti-Infective Drugs Advisory Committee to the U.S. Food and Drug Administration regarding telavancin for the treatment of complicated skin and skin structure infections.  The press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
<br>
<p>
<b>Item 9.01. Financial Statements and Exhibits</b></b><br>
<br><b>
<b>(d) Exhibits</b><br>
<br>

<p>
&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;  99.1 &nbsp; &nbsp; &nbsp; <a href="theravanceinc8k4542.htm">Press Release of Theravance, Inc. dated November  19, 2008</a></b>
<p>
<p>
<hr size=1>
<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>
</td></tr>
</table>
<br>
<table>
<tr>
<td width="50%" valign=top>
Dated: November  19, 2008<br>
</td>
<td>
<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>
</td></tr>
</table>
<hr>
<center>
<table border=0 width="100%">
<tr><td colspan=2>
<center><b>Exhibit Index</b></center>
</td>
</tr>
<tr>
<td width=50% align=center><b><u>Exhibit No.</u></b></td>
<td width=50% align=center><b><u>Description</u></b></td>
</tr>
<tr>
<td align=center>99.1</td>
<td align=center>Press Release of Theravance, Inc. dated November  19, 2008</td>
</tr>
</table>
</TEXT>
</DOCUMENT>
<DOCUMENT>
<TYPE>EX-99
<SEQUENCE>2
<FILENAME>theravanceinc8k4542.htm
<DESCRIPTION>THERAVANCE, INC. PRESS RELEASE
<TEXT>

<p></p>
<b>Theravance Reports Favorable Outcome of FDA Advisory Committee Meeting on Telavancin for the Treatment of Complicated Skin and Skin Structure Infections</b>
<p>SOUTH SAN FRANCISCO, CA -- 11/19/2008 --  Theravance, Inc. (NASDAQ: THRX)
announced today that telavancin received a favorable recommendation from
the Anti-Infective Drugs Advisory Committee (AIDAC) of the U.S. Food and
Drug Administration (FDA) for the proposed indication to treat complicated
skin and skin structure infections (cSSSIs) caused by Gram-positive
bacteria, including resistant pathogens such as methicillin-resistant
Staphylococcus aureus (MRSA).  The Committee voted 21 to 5 that the data
presented demonstrate the safety and effectiveness of telavancin for
treatment of cSSSIs.  The Committee also voted 18 to 5 (with 3 abstentions)
that there are specific clinical situations in which the benefits of
telavancin use in pregnant women with cSSSI would outweigh the risks, and
25 to 1 that a risk management strategy is needed to prevent unintended use
of telavancin in pregnant women or women of child-bearing potential.
Telavancin is a novel, bactericidal, once-daily injectable investigational
antibiotic discovered by Theravance.
</p>
<p>
"Today's positive outcome is a significant milestone for telavancin, an
important potential weapon against serious bacterial infections," said Rick
E Winningham, Chief Executive Officer of Theravance.  "We will continue to
work closely with the FDA as they complete their review of the telavancin
NDA."
</p>
<p>
"We are very pleased that Anti-Infective Drugs Advisory Committee members
acknowledged the critical need for new anti-infectives to treat complicated
skin and skin structure infections," said William E Fitzsimmons, Pharm.D.,
Senior Vice President, Research and Development, at Astellas Pharma US,
Inc.  "We look forward to the opportunity to introduce this important new
option for physicians and patients battling these serious drug-resistant
infections."
</p>
<p>
Although it is not binding, the Committee's recommendation will be
considered by the FDA as it completes its review of the cSSSI NDA for
telavancin.  The FDA has not yet established a revised Prescription Drugs
User Fee Act (PDUFA) action date for the telavancin NDA.
</p>
<p>
About Telavancin
</p>
<p>
Telavancin is a bactericidal, once-daily injectable investigational
antibiotic with a multifunctional mechanism of action. Telavancin was
discovered by Theravance in a research program dedicated to finding new
antibiotics for serious infections due to Staphylococcus aureus and other
Gram-positive bacteria, including MRSA. Telavancin inhibits the formation
of the bacterial cell wall and disrupts bacterial cell membrane function.
Theravance believes the additive mechanisms of action seen with telavancin
speed bacterial killing while also reducing the risks of inducing
resistance to telavancin or cross-resistance with other antibiotics. If
approved, telavancin will be a new treatment option for serious
Gram-positive cSSSIs. In addition, two Phase 3 studies of telavancin have
been completed for the treatment of hospital-acquired pneumonia bacterial
infections.
</p>
<p>
About ATLAS 1 and ATLAS 2 Clinical Studies
</p>
<p>
The telavancin NDA is based on data from two large, multinational,
double-blind, randomized Phase 3 clinical studies designed to compare the
efficacy and safety of telavancin (10 mg/kg IV once daily) versus
vancomycin (1 gm IV q 12hr) in the treatment of cSSSIs caused by
Gram-positive bacteria. In both of these studies (ATLAS 1 and ATLAS 2),
which enrolled and treated 1,867 patients in total, 719 of whom had
infections with MRSA, telavancin achieved its primary endpoint of
non-inferiority relative to the standard of care, vancomycin. The safety
profile of telavancin in these studies was compatible with treatment of
patients with serious infections.
</p>
<p>
About the Telavancin Collaboration
</p>
<p>
In November 2005, Theravance entered into a collaboration arrangement with
Astellas Pharma Inc. for the development and commercialization of
telavancin worldwide except Japan. In July 2006, Theravance and Astellas
expanded the collaboration to include Japan. Under the terms of the
collaboration, Theravance will lead the development of and U.S. regulatory
activities for telavancin for the treatment of cSSSIs and hospital-acquired
pneumonia, and will collaborate substantially with Astellas in marketing in
the United States for the first three years. Astellas will lead all other
development, regulatory, manufacturing, sales and marketing activities.
</p>
<p>
About Theravance
</p>
<p>
Theravance is a biopharmaceutical company with a pipeline of internally
discovered product candidates. 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 gastrointestinal motility dysfunction. The company's key
programs include: telavancin for the treatment of serious Gram-positive
bacterial infections with Astellas Pharma Inc., the Horizon program and
Bifunctional Muscarinic Antagonist-Beta2 Agonist (MABA) program with
GlaxoSmithKline plc, and the Gastrointestinal Motility Dysfunction program.
By leveraging its proprietary insight of multivalency toward drug discovery
focused primarily on validated targets, Theravance is pursuing a next
generation strategy designed to discover superior medicines in areas of
significant unmet medical need. For more information, please visit the
company'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>
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 Exchange Act and the Private
Securities Litigation Reform Act of 1995. Examples of such statements
include statements regarding the potential benefits and mechanisms of
action of drug candidates, statements concerning the timing of seeking
regulatory approval of our product candidates (including with respect to
telavancin statements regarding any expectation that regulatory authorities
will approve telavancin on the basis of existing preclinical and clinical
data or at all) and the enabling capabilities of Theravance's approach to
drug discovery and its proprietary insights. 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, risks related to the
potential that results of clinical or preclinical studies indicate product
candidates are unsafe or ineffective, delays or failure to achieve
regulatory approvals, risks of relying on third-party manufacturers for the
supply of our 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
Item 1A of Theravance's Quarterly Report on Form 10-Q filed with the
Securities and Exchange Commission (SEC) on November 6, 2008 and the risks
discussed in our other periodic filings with the 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>
Contact Information:

Theravance, Inc.
Michael W. Aguiar
Senior Vice President and CFO
650-808-4100
investor.relations@theravance.com</a>

Sam Brown Inc. (Media)
Mike Beyer
773-463-4211
beyer@sambrown.com</a>


</pre>
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
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