Theravance Announces Positive Results in Phase 3 Telavancin Complicated Skin and Skin Structure Infection Program
Tuesday August 22, 5:00 pm ET
SOUTH SAN FRANCISCO, CA--(MARKET WIRE)--Aug 22, 2006 -- Theravance, Inc. (NASDAQ:THRX - News) today announced results from the ATLAS I and ATLAS II trials assessing the safety and efficacy of telavancin, a rapidly bactericidal injectable antibiotic, for the treatment of complicated skin and skin structure infections (cSSSI) caused by Gram-positive bacteria. ATLAS I and ATLAS II were two large, multi-center, multinational, double-blind, randomized Phase 3 clinical studies that enrolled and treated 1,867 patients in total, 719 of whom were infected with methicillin-resistant Staphylococcus aureus (MRSA). In each study, telavancin achieved its primary endpoint of non-inferiority. In both the all-treated and clinically evaluable populations, telavancin achieved a numerically better clinical cure rate versus vancomycin in cSSSI caused by Gram-positive bacteria.
In the clinically evaluable population of patients combined from ATLAS I and ATLAS II with cSSSI caused by MRSA:
-- telavancin showed a numerically better clinical cure rate than
vancomycin (telavancin 90.6% versus vancomycin 86.4%, p=0.060) and
-- telavancin achieved a numerically better microbiological eradication
rate than vancomycin (telavancin 89.9% versus vancomycin 85.4%, p=0.053).
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"This positive outcome represents a landmark event for our company and the team that helped make it happen," said Rick E Winningham, Chief Executive Officer at Theravance. "Telavancin is a Theravance-discovered medicine, and these data demonstrate that our innovative approach to drug discovery works and can have an impact on combating serious infections. With the data from this program, telavancin has the opportunity to become an important new medicine for the treatment of serious Gram-positive infections."
"This was the largest double-blind randomized clinical program ever conducted in the treatment of patients with complicated skin and skin structure infections, and included the most patients infected with MRSA evaluated in an anti-infective clinical research program to date," said Michael Kitt, MD, Senior Vice President of Development at Theravance. "I am extremely pleased we met our primary endpoint and observed a strong trend toward an improved clinical cure rate versus vancomycin for the treatment of patients infected with MRSA in this program. I would like to thank the physicians, study coordinators, nurses, pharmacists, and patients who participated in this program. We look forward to presenting our data for scientific review and submitting our new drug application to the U.S. Food & Drug Administration."
"With the incidence of methicillin-resistant Staphylococcus aureus infections on the rise, it is imperative that clinicians have effective alternatives in the treatment of these difficult infections," stated Sef Kurstjens, MD, PhD, Senior Vice President, Research and Development at Astellas Pharma US, Inc., an affiliate of Astellas Pharma Inc., the worldwide business partner for the development and commercialization of telavancin. "We are excited about the results of the ATLAS I and ATLAS II studies and look forward to working with Theravance in bringing this potential new treatment to physicians."
The safety profile of telavancin was consistent with that observed in prior clinical studies. 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.
Program Design
The cSSSI program consisted of two double-blind, randomized studies, ATLAS I and ATLAS II, designed to compare the efficacy and safety of telavancin versus vancomycin in the treatment of cSSSI caused by Gram-positive bacteria. The primary endpoint of each study was non-inferiority of telavancin in clinical cure rate versus vancomycin. The cSSSI program also included an endpoint of superiority in clinical cure rate of telavancin versus vancomycin in the pooled subset of patients from ATLAS I and ATLAS II with MRSA infections. Clinical cure was determined based upon physician-judged resolution of clinical signs and symptoms of cSSSI.
Conference Call and Webcast Information
The Company has scheduled a conference call to discuss this announcement beginning at 8:00 a.m. Eastern Daylight Time on August 23, 2006. To participate in the live call by telephone, please dial 800-289-0572 from the U.S., or 913-981-5543 for international callers. Those interested in listening to the conference call live via the internet may do so by visiting the company's web site at www.theravance.com. To listen to the live call, please go to the web site 15 minutes prior to its start to register, download, and install any necessary audio software.
A replay of the conference call will be available on the Company's web site for 30 days through September 22, 2006. An audio replay will also be available through 11:59 p.m. Eastern Daylight Time on September 6, 2006 by dialing 888-203-1112 from the U.S., or 719-457-0820 for international callers, and entering confirmation code 1254423. |
