Healthcare Industry News: Theravance
News Release - May 16, 2006
Theravance Announces Enrollment of Last Patient in Phase 3 Complicated Skin and Skin Structure Infections Clinical Program With Investigational Antibiotic, TelavancinSOUTH SAN FRANCISCO, CA--(Healthcare Sales & Marketing Network)--May 16, 2006 -- Theravance, Inc. (NasdaqNM:THRX ) announced today that it has enrolled the last patient in its first Phase 3 clinical program with the investigational antibiotic telavancin in patients with complicated skin and skin structure infections (cSSSI) due to Gram-positive bacteria, including resistant strains such as methicillin-resistant Staphylococcus aureus (MRSA).
"Completion of enrollment in the first Phase 3 program is an important step in the development of telavancin. We believe this is the largest clinical program ever conducted in patients with cSSSI caused by MRSA," said Michael Kitt, MD, Senior Vice President, Development at Theravance. "We have enrolled more than 1,800 patients overall and expect to have more than one-third with confirmed MRSA infections at baseline. 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 MRSA infections, if such superiority exists."
Telavancin is a rapidly bactericidal, injectable antibiotic with multiple mechanisms of action discovered at Theravance 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 integrity. We believe the additive mechanisms of action seen with telavancin speed bacterial killing while also reducing the risks of inducing resistance to telavancin or cross-resistance with other antibiotics. Telavancin is also in Phase 3 clinical studies for the treatment of patients with hospital-acquired pneumonia (HAP).
In November 2005, Theravance entered into a collaboration arrangement with Astellas Pharma Inc. (Astellas) for the development and commercialization of telavancin worldwide, except Japan. Under the terms of the collaboration, Theravance will lead the development of telavancin for the treatment of cSSSI and 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. The last clinical visit (test-of-cure visit) by the last patient in the cSSSI Phase 3 program will trigger a $25 million milestone payment from Astellas.
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.
Astellas Pharma US, Inc., located in Deerfield, Illinois, is a US affiliate of Tokyo-based Astellas Pharma Inc. 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. For more information about Astellas Pharma US, Inc., please visit our 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 and preclinical 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, 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, and 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, 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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