-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, MERm4/wvqM37R9nI0ATyxjjhNg54PljeHuuOBPMGb1lfgxaFtijt9Kh82fx/MPun ZaBHnYg/KFCR0l/QiatTQQ== 0001140361-07-013885.txt : 20070709 0001140361-07-013885.hdr.sgml : 20070709 20070709173029 ACCESSION NUMBER: 0001140361-07-013885 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20070709 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070709 DATE AS OF CHANGE: 20070709 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: 07970309 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 8-K 1 form8k.htm THERAVANCE 8-K 7-9-2007 form8k.htm


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC  20549
____________
 
FORM 8-K
____________

Current Report Pursuant
to Section 13 or 15(d) of the
Securities Exchange Act of 1934
 
Date of Report (Date of earliest event Reported):  July 9, 2007
____________
 
THERAVANCE, INC.
(Exact Name of Registrant as Specified in its Charter)
____________
 
Delaware
000-30319
94-3265960
(State or Other Jurisdiction of Incorporation)
(Commission File Number)
 (I.R.S. Employer Identification Number)

901 Gateway Boulevard
South San Francisco, California 94080
(650) 808-6000
(Addresses, including zip code, and telephone numbers, including area code, of principal executive offices)
____________

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 (see General Instruction A.2. below):
 
o
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
o
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
o
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
o
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 




Item 7.01.
Regulation FD Disclosure.

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.

On July 9, 2007, Theravance, Inc. issued a press release regarding results from its Phase 2 clinical study of its investigational antibiotic TD-1792.  A copy of the press release is furnished as Exhibit 99.1 to this Current Report.
 
Item 9.01.
Financial Statements and Exhibits.
 
(d) Exhibits.
 
 
99.1
Press Release of Theravance, Inc. dated July 9, 2007
 


SIGNATURE
 
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.
 
   
 
THERAVANCE, INC.
     
     
Date:  July 9, 2007
By:
 /s/ Rick E Winningham
 
 
Rick E Winningham
 
 
Chief Executive Officer



EXHIBIT INDEX
 
 
Exhibit No.
 
Exhibit
 
Press Release of Theravance, Inc. dated July 9, 2007
 
 
 

EX-99.1 2 ex99_1.htm EXHIBIT 99.1 ex99_1.htm

 
Theravance Announces Positive Results From Phase 2 Clinical Study with Investigational Antibiotic in Patients with Complicated Skin and Skin Structure Infections

TD-1792 Achieves Primary Endpoint
 
 
SOUTH SAN FRANCISCO, CA/July 9, 2007 Theravance, Inc. (NASDAQ: THRX) today announced results from its large Phase 2 clinical study evaluating the safety and efficacy of its investigational antibiotic, TD-1792, in the treatment of complicated skin and skin structure infections (cSSSI) caused by Gram-positive bacteria, including resistant strains such as methicillin-resistant Staphylococcus aureus (MRSA).  The study met its primary endpoint of non-inferiority compared to vancomycin, the standard of care for resistant Gram-positive infections, in the clinically evaluable population, and also met key secondary endpoints.

Clinical cure rates in the clinically evaluable population were 91.7% for patients treated with TD-1792 (77/84) and 90.7% for patients treated with vancomycin (78/86).  Clinical cure rates in the clinically evaluable population for patients with confirmed MRSA infections were 94.7% for patients treated with TD-1792 (36/38) and 91.9% for patients treated with vancomycin (34/37).  In the all-treated population, clinical cure rates for patients treated with TD-1792 and standard therapy, respectively, were 80.6% (79/98) versus 82.8% (82/99).  In the group of microbiologically evaluable patients, eradication was achieved in 93.7% of the group treated with TD-1792 (59/63) versus 92.1% in the group receiving vancomycin (58/63).

The overall incidence and severity of adverse events were similar in the TD-1792 and standard therapy groups.  There were no serious adverse events reported in the TD-1792 group compared with two in the vancomycin group.  Fewer patients receiving TD-1792 (n=2) discontinued treatment due to an adverse event compared with vancomycin (n=5).  The most common adverse events in both treatment groups included headache, nausea, small increases in liver enzymes (ALT, AST), and pruritus.
   
“We are extremely pleased with the results of our Phase 2 clinical study of this highly potent compound,” said Michael Kitt, MD, Senior Vice President of Development at Theravance.  “In particular, the favorable tolerability trends of TD-1792 confirm our decision to explore higher doses in our ongoing Phase 1 program.  We believe that the results of this study allow us to pursue more serious infections, such as bacteremia.”

About the Study
 
The study was randomized, double-blind, active-controlled and conducted in the United States comparing safety, efficacy, and tolerability of once-daily TD-1792 to twice-daily vancomycin, the standard of care for resistant Gram-positive infections, in patients with cSSSI caused by Gram-positive bacteria, including resistant strains such as MRSA.  One hundred and ninety-seven patients were randomized and received study medication with either 2 mg/kg TD-1792 dosed once daily or vancomycin dosed 1 gram twice daily for up to 14 days.  Aztreonam and/or metronidazole was added for Gram-negative or anaerobic coverage.  A test-of cure-visit was conducted between 7 and 14 days following the last day of treatment.  The primary endpoint was clinical cure for the clinically evaluable population at the test-of-cure visit.
 


Study populations for the results cited above were described as follows:

 
·
All Treated (AT):  patients received at least one dose of study medication
 
·
Clinically Evaluable (CE):  patients fulfilled all protocol criteria (inclusion/exclusion criteria, duration of therapy & evaluations)
 
·
Microbiologically Evaluable (ME):  Clinically Evaluable patients with microbiological confirmation of pathogen(s)

About TD-1792
 
TD-1792 is a highly potent, bactericidal, once-daily antibiotic discovered by Theravance through the application of multivalency.  The goal of the TD-1792 clinical program is to develop a next-generation antibiotic with a better therapeutic index than vancomycin for the treatment of serious infections caused by MRSA.  In preclinical in vitro studies, TD-1792 demonstrated marked bactericidal activity and was approximately 30-fold more potent than vancomycin against MRSA and approximately 100-fold more potent than oxacillin against methicillin-sensitive Staphylococcus aureus (MSSA).
 
Astellas Option
 
Astellas Pharma Inc. has an option to license TD-1792 for further development and commercialization on substantially the same terms under which Astellas has licensed telavancin.  For additional information regarding the collaboration agreement with Astellas, please refer to SEC filings on the investor relations portion of Theravance's website at www.theravance.com.
 
About Theravance
 
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.  Of the five programs in development, four are in late stage – its telavancin program focusing on treating serious Gram-positive bacterial infections in collaboration with Astellas Pharma Inc., its Gastrointestinal Motility Dysfunction program, the Beyond Advair collaboration with GlaxoSmithKline, and TD-1792 for the treatment of serious Gram-positive infections.  By leveraging its proprietary insight of multivalency to drug discovery focused on validated targets, Theravance is pursuing a next generation drug discovery strategy designed to discover superior medicines in large markets. For more information, please visit the company's web site at www.theravance.com.
 

 
Conference Call and Webcast Information
 
Theravance has scheduled a conference call to discuss this announcement today at 5:00 p.m. Eastern Daylight Time.  To participate in the live call, please dial 888-802-2266 from the U.S. and Canada, or 913-312-1270 for international callers.  The live webcast can be accessed from Theravance's web site at www.theravance.com.  Please go to the web site 15 minutes prior to its start to register, download, and install any necessary audio software.
 
A replay of the conference call and webcast will be available on the company's web site for 30 days through Wednesday, August 8, 2007.  An audio replay will also be available through 11:59 p.m. Eastern Daylight Time on July 23, 2007 by dialing 888-203-1112 from the U.S., or 719-457-0820 for international callers, and entering passcode 1043658.
 
 
THERAVANCE®, the Theravance logo, and MEDICINES THAT MAKE A DIFFERENCE® are registered trademarks of Theravance, Inc.

This press release contains and the conference call will contain 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 relating to the goals, timing and expected results of clinical and preclinical studies and regulatory review, statements regarding the potential benefits and mechanisms of action of drug candidates, the enabling capabilities of Theravance's approach to drug discovery and its proprietary insights, statements concerning expectations for product candidates through development and commercialization and projections of revenue and other financial items.  These statements are based on the current estimates and assumptions of the management of Theravance as of the date of this press release and the conference call 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 delays or difficulties in commencing or completing clinical and preclinical studies, the potential that results of clinical or preclinical studies indicate product candidates are unsafe, ineffective, inferior or not superior, delays or failure to achieve regulatory approvals, 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 May 8, 2007 and the risks discussed in our other 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.


 
Contact Information:
 
 
Allison Parker, Director, Investor Relations
650-808-4100
investor.relations@theravance.com
 
David Brinkley, Senior Vice President, Commercial Development
650-808-3784
dbrinkley@thervance.com
 
 



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