0001102624-13-001386.txt : 20131113 0001102624-13-001386.hdr.sgml : 20131113 20131113160124 ACCESSION NUMBER: 0001102624-13-001386 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20131113 ITEM INFORMATION: Regulation FD Disclosure FILED AS OF DATE: 20131113 DATE AS OF CHANGE: 20131113 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: 131214570 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 theravance8k.htm THERAVANCE, INC. 8-K theravance8k.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):  November 13, 2013
____________
 
THERAVANCE, INC.
(Exact Name of Registrant as Specified in its Charter)
____________

 
Delaware
(State or Other Jurisdiction of Incorporation)
000-30319
(Commission File Number)
94-3265960
(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 contained in this Item 7.01 shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Securities Exchange Act of 1934”), or incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.

Today Rick E Winningham, Chief Executive Officer of Theravance, Inc. (the "Company")  presented at the 2013 Credit Suisse Annual Health Care Conference in Scottsdale, Arizona.  During the slide presentation, Mr. Winningham announced that TD-9855 did not meet the primary efficacy endpoint of symptom reduction as measured by AISRS (Adult Investigator Symptom Rating Scale) total score versus placebo in the Phase 2 study in adult patients with Attention-Deficit/Hyperactivity Disorder (ADHD).  TD-9855 was generally well tolerated with no serious adverse events at either the 5 mg or 20 mg dose of TD-9855.  The most frequent adverse events observed in the study were headache, dizziness, decreased appetite, fatigue, and dry mouth.  Mr. Winningham announced that the Company will not be continuing its TD-9855 program in ADHD.  TD-9855 is currently being evaluated in an ongoing Phase 2 study in patients with fibromyalgia.  Results from the fibromyalgia Phase 2 study are anticipated during the first half of 2014.  TD-9855 is an investigational norepinephrine and serotonin reuptake inhibitor for the treatment of central nervous system conditions such as chronic pain.



 
 
 
 

 

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: November 13, 2013
  
By:
  
 /s/ Michael W. Aguiar                  
       
Michael W. Aguiar
       
Chief Financial Officer