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8-K Filing
Innoviva (INVA) 8-KOther Events
Filed: 7 Jul 14, 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: July 07, 2014 (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) | ||
951 Gateway Boulevard, South San Francisco, CA (Address of principal executive offices) | 94080 (Zip Code) | |||
650-238-9600 (Registrant's telephone number, including area code) | ||||
Not Applicable (Former Name or Former Address, if changed since last report) |
Item 8.01. Other Events On July 7, 2014, GlaxoSmithKline plc (GSK) and Theravance, Inc. issued a press release announcing that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved ANORO(R) ELLIPTA(R) (umeclidinium/vilanterol) for the relief of various symptoms due to airway obstruction with chronic obstructive pulmonary diseases (chronic bronchitis, pulmonary emphysema) (in the case where concurrent use of long-acting inhaled muscarinic antagonist and long-acting inhaled beta2 agonist is required). ANORO(R) is a once-daily combination treatment comprised of two bronchodilators, umeclidinium (UMEC), a long-acting muscarinic antagonist (LAMA), and vilanterol (VI), a long-acting beta2 agonist (LABA), in a single inhaler, the ELLIPTA(R). The approved dose in Japan is UMEC/VI 62.5/25mcg delivered once daily. Under the terms of the 2002 LABA collaboration agreement, Theravance is obligated to make a milestone payment of $10 million (USD) to GSK following MHLW approval of UMEC/VI in Japan. UMEC/VI has been developed under the LABA collaboration agreement between Glaxo Group Limited and Theravance, Inc. A copy of the press release is filed as Exhibit 99.1 to this report and is 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: July 07, 2014 | THERAVANCE, INC. By: /s/ Michael W. Aguiar |
Exhibit No. | Description |
99.1 | Press Release dated July 07, 2014 |