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8-K Filing
Innoviva (INVA) 8-KRegulation FD Disclosure
Filed: 10 Sep 13, 12:00am
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the |
Date of Report: September 10, 2013 (Date of earliest event reported) | ||||
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 (IRS Employer Identification Number) | ||
901 Gateway Boulevard, South San Francisco, CA (Address of principal executive offices) | 94080 (Zip Code) | |||
650-808-6000 (Registrant's telephone number, including area code) | ||||
Not Applicable (Former Name or Former Address, if changed since last report) |
Item 7.01. Regulation FD Disclosure The information contained in this Item 7.01 and in the accompanying exhibit 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. On September 10, 2013 GlaxoSmithKline plc (GSK) and Theravance, Inc. issued a press release announcing the outcome of the meeting of the Pulmonary-Allergy Drugs Advisory Committee to the U.S. Food and Drug Administration regarding umeclidinium bromide and vilanterol dry powder for inhalation (proposed trade name ANORO(TM) ELLIPTA(TM)) 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 (LAMA) and vilanterol (VI), a long-acting beta2 agonist (LABA), administered using the ELLIPTA(TM) inhaler. UMEC/VI is in development under the LABA collaboration agreement between Glaxo Group Limited and Theravance, Inc. The press release is attached hereto as Exhibit 99.1 and incorporated herein by reference. Item 9.01. Financial Statements and Exhibits (d) Exhibits 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. |
Dated: September 10, 2013 | THERAVANCE, INC. By: /s/ Michael W. Aguiar |
Exhibit No. | Description |
99.1 | Press Release dated September 10, 2013 |