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): May 9, 2013
THERAVANCE, INC.
(Exact Name of Registrant as Specified in its Charter)
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Delaware (State or Other Jurisdiction of |
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000-30319 (Commission File Number) |
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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 in this Current Report (including Exhibits 99.1, 99.2 and 99.3) is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Securities Exchange Act of 1934”), or otherwise subject to the liabilities of that Section. The information in this Current Report (including Exhibits 99.1, 99.2 and 99.3) 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 May 9, 2013 at the 32nd Annual Scientific Meeting of the American Pain Society, New Orleans, Louisiana, posters presenting information from Theravance, Inc.’s Study 76 and Study 84 of the Phase 2b program with TD-1211 in patients with opioid-induced constipation were made available for viewing. TD-1211 is an investigational once-daily, orally administered, peripherally selective, multivalent inhibitor of the mu opioid receptor designed with a goal of alleviating gastrointestinal side effects of opioid therapy without affecting analgesia. Copies of the posters are furnished as Exhibits 99.1, 99.2 and 99.3 to this report and are incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
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Exhibit |
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Description |
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Exhibit 99.1 |
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TD-1211 Demonstrates Tolerability and Clinical Activity Following Multiple Treatment Administration Strategies in Patients with Opioid-Induced Constipation |
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Exhibit 99.2 |
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TD-1211 Demonstrates a Durable Increase in Bowel Movement Frequency and Return Toward Normal Bowel Function in a 5-Week Phase 2b Opioid-Induced Constipation Study |
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Exhibit 99.3 |
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No Evidence of Analgesic Interference or CNS Opioid Withdrawal for TD-1211 in a Phase 2b Study in Opioid-Induced Constipation |
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.
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THERAVANCE, INC. | |
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Date: May 9, 2013 |
By: |
/s/ Michael W. Aguiar |
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Michael W. Aguiar |
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Chief Financial Officer |
EXHIBIT INDEX
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Exhibit No. |
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Description |
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Exhibit 99.1 |
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TD-1211 Demonstrates Tolerability and Clinical Activity Following Multiple Treatment Administration Strategies in Patients with Opioid-Induced Constipation |
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Exhibit 99.2 |
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TD-1211 Demonstrates a Durable Increase in Bowel Movement Frequency and Return Toward Normal Bowel Function in a 5-Week Phase 2b Opioid-Induced Constipation Study |
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Exhibit 99.3 |
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No Evidence of Analgesic Interference or CNS Opioid Withdrawal for TD-1211 in a Phase 2b Study in Opioid-Induced Constipation |