VibativTreatment for Complicated Skin and Skin Structure Infections (cSSSI), Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP)
Update: Vibativ (telavancin) Now FDA Approved - September 11, 2009
Theravance Receives Notice of Possible Telavancin Review by FDA Advisory Committee
SOUTH SAN FRANCISCO, CA/ December 27, 2007 – Theravance, Inc. today announced that it has received notice from the U.S. Food and Drug Administration (FDA) that the agency's Anti-Infective Drugs Advisory Committee may soon meet to review the NDA for telavancin, a novel, bactericidal, once-daily injectable antibiotic proposed to treat complicated skin and skin structure infections (cSSSI) caused by Gram-positive bacteria, including resistant pathogens such as methicillin-resistant Staphylococcus aureus (MRSA). Further details will be provided by Theravance upon receipt of additional information from FDA.
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 six programs in development, four are in late stage – its telavancin program focusing on treating serious Gram-positive bacterial infections with Astellas Pharma Inc., the Gastrointestinal Motility Dysfunction program, the Beyond Advair collaboration with GlaxoSmithKline plc, and TD-1792 for the treatment of serious Gram-positive bacterial infections. By leveraging its proprietary insight of multivalency toward drug discovery focused on validated targets, Theravance is pursuing a next generation strategy designed to discover superior medicines in areas of significant unmet medical need. For more information, please visit the company's web site at www.theravance.com.
About Telavancin Collaboration
Theravance and Astellas Pharma Inc. (Astellas) have a collaboration arrangement for the development and commercialization of telavancin worldwide. Under the terms of the collaboration, Theravance will lead the development of and U.S. regulatory process for telavancin for the treatment of cSSSI and hospital-acquired pneumonia (HAP), and will collaborate substantially with Astellas in marketing in the United States for the first three years. Astellas will lead all other development, regulatory, manufacturing, sales and marketing activities.
THERAVANCE, the Theravance logo, and MEDICINES THAT MAKE A DIFFERENCE are registered trademarks of Theravance, Inc.
This press release contains 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, statements regarding the potential benefits and mechanisms of action of drug candidates, statements concerning the goals and timing of seeking regulatory approval of our product candidates (including with respect to telavancin statements regarding any expectation that we will be able to respond fully or adequately to FDA's requests using currently existing clinical data, any expectation that the third-party manufacturer will successfully address the cGMP issues the FDA has noted, and any expectation that the FDA will approve the telavancin NDA on the basis of existing preclinical and clinical data or at all), 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 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, the potential that results of clinical or preclinical studies indicate product candidates are unsafe, ineffective, inferior or not superior, and delays or failure to achieve regulatory approvals, risks of collaborating with third parties to develop and commercialize products and risks of relying on third-party manufacturers for the supply of our product candidates. 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 November 7, 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.
Director, Investor Relations
Posted: January 2008
- FDA Approves Vibativ for Hospitalized Patients with Bacterial Pneumonia - June 21, 2013
- Theravance and Astellas Announce FDA Approval of Vibativ (telavancin) for the Treatment of Complicated Skin and Skin Structure Infections - September 13, 2009
- FDA Accepts for Review Theravance's Complete Response Submission for Telavancin for the Treatment of Complicated Skin and Skin Structure Infections - April 25, 2009
- Theravance Announces FDA Acceptance of Telavancin NDA for the Treatment of Hospital-Acquired Pneumonia - April 7, 2009
- Theravance Receives Complete Response Letter on the Telavancin New Drug Application for the Treatment of cSSSI - February 27, 2009
- Theravance Submits U.S. NDA for Telavancin for the Treatment of Hospital-Acquired Pneumonia - January 27, 2009
- Theravance Reports Favorable Outcome of FDA Advisory Committee Meeting on Telavancin for the Treatment of Complicated Skin and Skin Structure Infections - November 20, 2008
- FDA Accepts for Review Theravance's Complete Response to Approvable Letter for Telavancin for the Treatment of Complicated Skin and Skin Structure Infections - March 6, 2008