Astellas and Theravance Report Additional Telavancin Data at 47th Annual ICAACResults from Preclinical and Clinical Studies Demonstrate Activity of Investigational Agent against Gram-Positive Bacteria
CHICAGO, September 18, 2007 /PRNewswire/ -- Astellas Pharma US, Inc. and Theravance, Inc. announced today results with the investigational compound telavancin from the largest subset of surgical-site-associated complicated skin and skin structure infections (cSSSIs) from a controlled Phase 3 clinical program in patients with complicated Gram-positive cSSSIs, and results from preclinical and surveillance studies were recently presented at the 47th annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) meeting in Chicago, Illinois.
Telavancin is a novel lipoglycopeptide injectable antibiotic discovered by Theravance that was engineered to have a unique, multifunctional mechanism of action; it inhibits the formation of the bacterial cell wall and disrupts bacterial cell membrane function. Telavancin is currently being evaluated by regulatory authorities in the United States and Europe for its safety and efficacy in the treatment of complicated skin and skin structure infections and is in Phase 3 studies for the treatment of hospital-acquired pneumonia.
The following clinical activity of telavancin was reported at ICAAC. New data from an analysis of a subset of nearly 200 patients with surgical-site-associated complicated skin and skin structure infections (cSSSIs) suggest that once-daily telavancin is clinically active in surgical-site-associated cSSSIs due to Staphylococcus aureus, including methicillin-resistant Staphylococcus aureus (MRSA). These data are from the ATLAS (Assessment of TeLAvancin in complicated Skin and skin structure infections) studies and represent the largest subset of surgical-site-associated cSSSIs from controlled clinical trials. In these studies, investigators compared clinical and microbiological responses from treatment with telavancin and vancomycin. In this subset, clinical cure, bacterial eradication and overall response rates were typically higher for telavancin.
Staphylococcus aureus is a common cause of surgical-site infections. Physicians report an increased proportion of these infections due to MRSA, a serious, potentially life-threatening infection that is becoming increasingly resistant to current treatments.
"Surgical site infections are a significant cause of death following surgery, and while vancomycin is a mainstay for treatment of these infections caused by MRSA, its decreasing effectiveness highlights the need for new antibiotics," said Samuel E. Wilson, MD, Professor of Surgery, University of California Irvine School of Medicine. "We are hopeful that telavancin will be a safe and useful treatment for serious and life-threatening complicated skin and skin structure infections."
Multiple Studies Support Telavancin
In addition to the analysis of a subset of patients with surgical site infections, 13 other telavancin abstracts were accepted at this year's ICAAC meeting. These data from multiple studies, taken in their entirety, provide insight into the potential benefits of telavancin. Abstracts included:
-- Comparative Use of Telavancin and Daptomycin Against MRSA in the Neutropenic Murine Thigh Model In this study, mice thigh tissue was injected with MRSA and dosed with telavancin or daptomycin three or eight hours later. At three hours following MRSA injection, reduction in bacteria concentrations were comparable between the two treatments. However, at eight hours, telavancin reduced bacteria concentrations to a greater degree than daptomycin. -- Antimicrobial Activity of Telavancin against Contemporary Enterococci and Streptococci: Initial results from a Global Surveillance Program This study was designed to examine the activity of telavancin against both enterococci and streptococci pathogens versus the commonly used drugs vancomycin, levofloxacin, daptomycin, linezolid and quinupristin/dalfopristin. In the more than 2,700 clinical isolates tested, telavancin was one of the most potent agents. When evaluated in light of other data on bactericidal effect in staphylococci infections, the totality of data suggest clinical activity across the range of Gram-positive bacteria.
The ATLAS studies were two separate but identical, randomized, double-blind trials to evaluate the efficacy and safety of telavancin versus vancomycin in patients with cSSSIs, especially those due to MRSA. In the ATLAS studies, telavancin contained the largest subset of patients over 18 years old with surgical-site associated cSSSIs of any randomized, double-blind study to date. The most common adverse events reported in patients receiving telavancin were mild to moderate taste disturbance and nausea. In addition, consistent with previous studies, small percentages of telavancin-treated patients experienced renal adverse events or increases in the QTc interval. In ATLAS, the most commonly reported (>10%) adverse events in patients treated with telavancin were taste disturbance, nausea, vomiting, headache, and foamy urine.
MRSA: A Growing Global Epidemic
An estimated 1.2 million hospitalized patients in the United States may be infected with MRSA, a type of bacteria that is resistant to antibiotics commonly used to treat staphylococci infections. In the healthcare setting, the proportion of resistant infections has grown. In 2004, according to the Centers for Disease Control (CDC), MRSA infections accounted for approximately 63 percent of the total number of staphylococci infections. Over the last five years, MRSA infections have increased nearly ten-fold and currently represent more than 50 percent of emergency department cSSSIs. Data from a 2003 CDC study suggests that about 12 percent of clinical MRSA infections are community-associated.
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.
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, four are in late stage -- its telavancin program focusing on treating serious Gram-positive bacterial infections with Astellas Pharma Inc., the Gastrointestinal Motility Dysfunction program, the Beyond Advair collaboration with GlaxoSmithKline plc and TD-1792 for the treatment of serious Gram-positive infections. By leveraging its proprietary insight of multivalency toward drug discovery focused on validated targets, Theravance is pursuing a next generation strategy designed to discover superior medicines in large markets. For more information, please visit the company's web site at http://www.theravance.com.
About Astellas Pharma US, Inc.
Astellas Pharma US, Inc., located in Deerfield, Illinois, is a U.S. 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 category leader in focused areas by combining outstanding R&D and marketing capabilities. In the U.S., Astellas markets products in the areas of immunology, urology, anti- infectives, cardiovascular and dermatology.
Trademarks listed belong to their respective owners.
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 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, 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, 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 August 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: Astellas Pharma US Inc. Corporate Communications Maribeth Landwehr 847-317-8988 Theravance, Inc. Investors/Media Allison Parker Director, Investor Relations firstname.lastname@example.org email@example.com
CONTACT: Maribeth Landwehr, Corporate Communications of Astellas Pharma USInc., +1-847-317-8988, ; or investors andmedia, Allison Parker, Director, Investor Relations of Theravance, Inc.,+1-650-808-4100, firstname.lastname@example.org email@example.com
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Posted: September 2007