SOURCE: Theravance, Inc.

January 03, 2007 08:30 ET

Theravance Initiates Phase 2 Clinical Program with Investigational Heterodimer Antibiotic

First Patient Dosed in Complicated Skin and Skin Structure Infection Study

SOUTH SAN FRANCISCO, CA -- (MARKET WIRE) -- January 3, 2007 --Theravance, Inc. (NASDAQ: THRX) announced today that the first patient was dosed in a Phase 2 clinical study of TD-1792, an investigational heterodimer antibiotic, for the treatment of complicated skin and skin structure infections (cSSSI) caused by Gram-positive bacteria, including resistant strains such as methicillin-resistant Staphylococcus aureus (MRSA). The goal of this program is to develop a next-generation antibiotic that is more efficacious than vancomycin, the current standard of care for the treatment of serious infections caused by MRSA, and which has an improved resistance profile relative to other available antibiotics.

TD-1792 is a unique heterodimer antibiotic discovered by Theravance that combines the antibacterial activities of a glycopeptide and a beta-lactam in one molecule. Theravance initiated the Phase 2 program based upon favorable data from preclinical studies and Phase 1 studies completed during 2006. In randomized, double-blind, placebo-controlled, single- and multiple-ascending dose Phase 1 studies, which enrolled a total of 51 healthy volunteers, TD-1792 was generally well tolerated and displayed linear pharmacokinetics and exposure profiles consistent with once-daily dosing. In preclinical in-vitro studies, TD-1792 demonstrated marked bactericidal activity and was approximately 30-fold more potent than vancomycin against MRSA and approximately 100-fold more potent than oxacillin against methicillin-sensitive Staphylococcus aureus (MSSA).

The Phase 2 randomized, double-blind, active-controlled study is designed to evaluate the safety and efficacy of TD-1792 in patients with cSSSI due to Gram-positive bacteria such as MRSA. Patients will be randomized to receive either TD-1792 dosed once daily or vancomycin dosed twice daily for up to 14 days. The Phase 2 study will be conducted in the United States with a goal of enrolling approximately 200 patients.

"We are excited about the potential of this compound as a next-generation treatment for serious Gram-positive infections, including those caused by MRSA," said Michael Kitt, MD, Senior Vice President of Development at Theravance. "MRSA is a worldwide health problem. We are striving to provide the best medicines to treat the increasing number of patients who are infected with MRSA."

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

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, 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 and statements concerning expectations for product candidates through development and commercialization. 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 delays or difficulties in commencing or completing clinical and preclinical studies, 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. 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.

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