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August 22, 2006
Theravance Announces Positive Results in Phase 3 Telavancin Complicated Skin and Skin Structure Infection Program
Founded by Roy Vagelos and George Whitesides, Theravance
is developing drugs for different clinical problems, including
respiratory disease, bacterial infections, and gastrointestinal
motility dysfunction. Its development programs include
the antibiotic telavancin, which is in Phase III trials.
We believe that telavancin represents a major new antibiotic
for gram positive bacteria, including methicillin-resistant
Staphylococcus aureus (MRSA). Below, Theravance reports
meeting its primary endpoint in two Phase III trials.
The company has a collaboration arrangement with Astellas
Pharma, Inc. for the development and commercialization
of telavancin worldwide which is worth $221 million in
milestone payments in addition to a significant royalty
on global sales.
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Theravance, Inc. (NASDAQ: THRX) 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 III 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).
"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.
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