SOURCE: Theravance, Inc.

February 20, 2007 17:00 ET

Theravance Announces FDA Acceptance of Telavancin NDA

NDA Filing Triggers Milestone Payment of $31 Million

SOUTH SAN FRANCISCO, CA -- (MARKET WIRE) -- February 20, 2007 -- Theravance, Inc. (NASDAQ: THRX) announced today that the U.S. Food & Drug Administration (FDA) has accepted the New Drug Application (NDA) for its investigational antibiotic telavancin for the treatment of complicated skin and skin structure infections (cSSSI) caused by Gram-positive organisms, including methicillin-resistant Staphylococcus aureus (MRSA). The FDA has established a goal of a standard ten-month review of the telavancin NDA. The NDA filing triggers a milestone payment of $31 million from Theravance's partner, Astellas Pharma Inc.

The NDA submission is based on data from two, large, multinational, double-blind, randomized Phase 3 clinical studies. In both of these studies (ATLAS 1 and ATLAS 2), which enrolled and treated 1,867 patients in total, 719 of whom were infected with MRSA, telavancin achieved its primary endpoint of non-inferiority to vancomycin. Telavancin compared favorably to standard therapy in clinical cure, microbiological eradication, and overall therapeutic response rates. The safety profile of telavancin in these studies was compatible with treatment of patients with serious infections due to resistant bacteria.

"We are very pleased that the FDA has accepted our NDA," said Rick E Winningham, Theravance's Chief Executive Officer. "With the data included in our NDA, telavancin has the opportunity to become an important new medicine for the treatment of serious Gram-positive infections, especially MRSA. We will continue to work closely with the FDA to facilitate its review of our NDA."

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. Of the five programs in development, two are in late stage -- its telavancin program focusing on treating serious Gram-positive bacterial infections with Astellas Pharma Inc. and the Beyond Advair collaboration with GlaxoSmithKline. By leveraging its proprietary insight of multivalency to drug discovery focused on validated targets, Theravance is pursuing a next generation drug discovery strategy designed to discover superior medicines in large markets. For more information, please visit the Company's web site at www.theravance.com.

About Telavancin Collaboration

In November 2005, Theravance entered into a collaboration arrangement with Astellas Pharma Inc. (Astellas) for the development and commercialization of telavancin worldwide except Japan. In July 2006, Theravance and Astellas expanded the collaboration to include Japan. Under the terms of the collaboration, Theravance will lead the development of telavancin for the treatment of cSSSI and hospital-acquired pneumonia, 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.

About Astellas

Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. The organization is committed to becoming a global pharmaceutical company by combining outstanding R&D and marketing capabilities and continuing to grow in the world pharmaceutical market. Astellas Pharma US, Inc., located in Deerfield, Illinois, is a US affiliate of Tokyo-based Astellas Pharma Inc. For more information about Astellas Pharma US, Inc., please visit its website at www.astellas.com/us.

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 studies and regulatory review, statements regarding the potential benefits and mechanisms of action of drug candidates, 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, delays or failure to achieve regulatory approvals, 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 Item 1A of Theravance's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 6, 2006 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.

Contact Information

  • Contact Information:

    Investors
    Theravance, Inc.
    Allison Parker
    Director, Investor Relations
    650-808-4100
    Email Contact

    Media
    Theravance, Inc.
    David Brinkley
    Senior Vice President, Commercial Development
    650-808-3784
    Email Contact