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Theravance Announces Enrollment of Last Patient in Phase 3 Hospital-Acquired Pneumonia Clinical Program With Investigational Antibiotic, Telavancin

Posted on: Wednesday, 20 June 2007, 18:00 CDT

Theravance, Inc. (NASDAQ: THRX) announced today that it has enrolled the last patient in its Phase 3 clinical program with the investigational antibiotic telavancin in patients with hospital-acquired pneumonia (HAP) due to Gram-positive bacteria, including resistant strains such as methicillin-resistant Staphylococcus aureus (MRSA). Telavancin is currently under regulatory review in both the United States and Europe for the treatment of complicated skin and skin structure infections (cSSSI) caused by Gram-positive bacteria.

"Completing enrollment in the HAP Phase 3 program is an important milestone for Theravance in the development of telavancin," said Rick E Winningham, Chief Executive Officer at Theravance. "There is a significant unmet medical need for patients with hospital-acquired pneumonia due to the high mortality rates associated with this disease. We believe that telavancin has the potential to be an important new medicine in the treatment of these life-threatening infections."

"This program consisted of two studies with identical protocols in which we enrolled more than 1,500 patients in total," said Michael Kitt, MD, Senior Vice President, Development at Theravance. "The design of the Phase 3 program gives us the opportunity to detect clinical superiority of telavancin over vancomycin, in the treatment of patients with HAP caused by MRSA, if such superiority exists. We currently expect to have results from these studies toward the end of the year."

Telavancin is a rapidly bactericidal, injectable antibiotic with a multifunctional mechanism of action. Theravance discovered telavancin in a research program dedicated to finding new antibiotics for serious infections due to Staphylococcus aureus and other Gram-positive bacteria. Telavancin inhibits the formation of the bacterial cell wall and disrupts bacterial cell membrane function.

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 leads the development of telavancin for the treatment of cSSSI and HAP, and will collaborate substantially with Astellas in marketing for the first three years in the United States. Astellas leads all other development, regulatory, manufacturing, sales and marketing activities. The last clinical visit (test-of-cure visit) by the last patient in the HAP Phase 3 program triggers a $25 million milestone payment from Astellas.

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 Astellas

Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. Astellas has approximately 13,900 employees worldwide. The organization is committed to becoming a global category leader by rapidly establishing a business model in Urology, Immunology and Inflammatory, Diabetes, CNS/Pain, Infectious diseases (virus), and Cancer. We have discovered an over-active bladder (OAB) medication, Vesicare(R) and an immunosuppressive agent, Prograf(R) (tacrolimus), which have enabled us to become an established leader in both Urology and Immunology. 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(R), the Theravance logo, and MEDICINES THAT MAKE A DIFFERENCE(R) 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 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, 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, 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 May 8, 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.

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

SOURCE: Theravance, Inc.

Source: MARKET WIRE

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