SOURCE: Theravance, Inc.

Theravance, Inc.

September 13, 2010 08:00 ET

Theravance Announces Data From the RELOVAIR™ Program to Be Presented at the European Respiratory Society Annual Congress

GSK Will Be Presenting a Total of 13 Preclinical and Clinical Abstracts for RELOVAIR™ and Its Individual Components in COPD and Asthma

SOUTH SAN FRANCISCO, CA--(Marketwire - September 13, 2010) - Theravance, Inc. (NASDAQ: THRX) today announced that data from the RELOVAIR™ program will be presented by GlaxoSmithKline (GSK) at the European Respiratory Society (ERS) Annual Congress, September 18-22, 2010 in Barcelona, Spain. RELOVAIR™ is being developed as a once-daily treatment combination of a long-acting beta agonist, vilanterol trifenatate (VI), and an inhaled corticosteroid, fluticasone furoate (FF) for patients with chronic obstructive pulmonary disorder (COPD) or asthma.

A total of 13 preclinical and clinical abstracts for RELOVAIR™ and its individual components in COPD and asthma were accepted by ERS for presentation, of which eight highlight results of Phase 2 and Phase 2b studies.

September 19, 2010: Posters

  1. A Woodcock, ER Bleecker, ED Bateman, W Busse, J Lötvall, N Snowise, R Forth, L Jacques, B Haumann. Fluticasone furoate (FF), a novel inhaled corticosteroid (ICS), demonstrates once-daily (OD) efficacy in asthma when dosed in the evening.

  2. Bateman E, Bleecker E, Busse W, Lötvall J, Woodcock A, Forth R, Medley H, Jacques L, Haumann B. Fluticasone Furoate (FF) a once daily inhaled corticosteroid (ICS) demonstrates dose-response efficacy in subjects symptomatic on non-steroidal asthma therapy.

  3. E Bleecker, E Bateman, W Busse, J Lotvall, A Woodcock, R Forth, K House. Fluticasone Furoate (FF) a novel once daily inhaled corticosteroid (ICS) demonstrates efficacy in subjects symptomatic on low doses of ICS asthma therapy.

  4. W Busse, E Bleecker, E Bateman, J Lotvall, A Woodcock, R Forth, A M Davis. Fluticasone Furoate (FF) a novel once daily inhaled corticosteroid (ICS) demonstrates efficacy in subjects symptomatic on moderate doses of ICS asthma therapy.

  5. N Hanania, G Feldman, J J Shim, W Zachgo, F Barnhart, C Crim, L Sanford, S Lettis. Safety of vilanterol trifenatate (VI) in a COPD dose-ranging study.

  6. Hanania N, Feldman G, Zachgo W, Shim J, Crim C, Sanford L, Lettis S, Barnhart F, Haumann B. Dose-related efficacy of vilanterol trifenatate (VI) in COPD.

The ERS embargo for these posters will be lifted at the end of the session at 14:40 CEST on September 19, 2010.

September 22, 2010: Oral Presentations

  1. J Lotvall, P Bakke, L Bjermer, S Steinshamn, C Crim, L Sanford, C Scott-Wilson, B Haumann. Safety and efficacy of fluticasone furoate/vilanterol trifenatate (FFVI) in COPD patients.

  2. J Lotvall, ED Bateman, ER Bleecker, W Busse, A Woodcock, R Follows, J Lim, S Stone, L Jacques, B Haumann. Dose-related efficacy of vilanterol trifenatate (VI), a long-acting beta2 agonist (LABA) with inherent 24-hour activity, in patients with persistent asthma.

The ERS embargo for these presentations will be lifted at the end of the session at 12:45 CEST on September 19, 2010.

The full abstracts are now available online at the ERS website (http://erscongress2010.org). 

About Theravance

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. The company's key programs include: VIBATIV™ (telavancin) with Astellas Pharma Inc. and the RELOVAIR™ program and Bifunctional Muscarinic Antagonist-Beta2 Agonist (MABA) program with GlaxoSmithKline plc. By leveraging its proprietary insight of multivalency toward drug discovery, Theravance is pursuing a best-in-class 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.

THERAVANCE®, the Theravance logo, and MEDICINES THAT MAKE A DIFFERENCE® are registered trademarks of Theravance, Inc.

VIBATIV is a trademark of Astellas Pharma Inc.

RELOVAIR is a trademark of Glaxo Group Limited. Mark is intended for U.S. and subject to FDA approval.

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 regarding the potential benefits of drug candidates and statements concerning enabling capabilities of Theravance's approach to drug discovery and its proprietary insights. 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, risks related to the potential that results of clinical or preclinical studies indicate product candidates are unsafe or ineffective and risks of collaborating with third parties to develop and commercialize products. These and other risks are described in greater detail under the heading "Risk Factors" contained in Theravance's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 4, 2010 and the risks discussed in our other period filings with 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.

Contact Information

  • Contact Information:

    Michael W. Aguiar
    Senior Vice President and Chief Financial Officer
    650-808-4100
    Email Contact