TOKYO and SOUTH SAN FRANCISCO, CA -- 10/28/09 --
Astellas Pharma Inc.
(Astellas) and Theravance, Inc. (NASDAQ: THRX) announced today that
Astellas Pharma Europe B.V. submitted a Marketing Authorization Application
(MAA) to the European Medicines Agency (EMEA) for telavancin, a
bactericidal, once-daily injectable lipoglycopeptide antibiotic, for the
treatment of nosocomial pneumonia (NP), including ventilator-associated
pneumonia, and complicated skin and soft tissue infections (cSSTI) in
adults.
"We are extremely pleased that this critical step has now been completed,"
said Mr. Masao Yoshida, President and CEO of Astellas Pharma Europe Ltd.
"We look forward to working with the regulatory authorities and our
partner, Theravance, to efficiently progress telavancin through the
remaining steps to approval."
"The MAA submission represents an important step toward our goal of making
telavancin globally available to physicians and patients," said Rick E
Winningham, Chief Executive Officer at Theravance. "We will work closely
with our partner Astellas in seeking the approval of telavancin in the
European Union."
About Telavancin
Telavancin was discovered by Theravance in a research program dedicated to
finding new antibiotics for serious infections due to Staphylococcus aureus
and other Gram-positive bacteria, including MRSA. Telavancin is a
bactericidal, once-daily, injectable lipoglycopeptide antibiotic with a
dual mechanism of action whereby telavancin both inhibits bacterial cell
wall synthesis and disrupts bacterial cell membrane function. VIBATIV(TM)
(telavancin) is approved in the United States and in Canada for the
treatment of adult patients with complicated skin and skin structure
infections (cSSSI) caused by susceptible isolates of the following
Gram-positive microorganisms: Staphylococcus aureus (including
methicillin-susceptible and -resistant isolates), Streptococcus pyogenes,
Streptococcus agalactiae, Streptococcus anginosus group (includes S.
anginosus, S. intermedius and S. constellatus) and Enterococcus faecalis
(vancomycin-susceptible isolates only). The U.S. Food and Drug
Administration is currently reviewing the telavancin New Drug Application
for the treatment of nosocomial pneumonia.
About the Clinical Studies
The MAA is based on data from the ATLAS I and II and ATTAIN I and II
clinical studies in adult patients.
ATLAS I and ATLAS II were two large, multinational, double-blind,
randomized Phase III clinical studies, designed to compare the efficacy and
safety of telavancin (10 mg/kg IV once daily) versus vancomycin (1 gm IV q
12hr) in adult patients with complicated skin and skin structure infections
(cSSSI) caused by Gram-positive bacteria. A total of 1,867 patients were
enrolled and treated, 719 of whom had infections with MRSA. In both of
these studies, telavancin achieved its primary endpoint of non-inferiority
relative to the standard of care, vancomycin.
ATTAIN I and ATTAIN II were two large, multi-center, multinational,
double-blind, randomized Phase III clinical studies, in which 1,503
patients were enrolled and treated, 464 of whom were infected with MRSA.
Patients with NP suspected or proven to be caused by Gram-positive bacteria
were randomized (1:1) to receive either telavancin 10 mg/kg IV once daily
or vancomycin 1 g IV every 12hr (the protocols allowed vancomycin dosage to
be modified per site-specific guidelines). For patients with suspected or
proven polymicrobial infections involving Gram-negative and/or anaerobic
bacteria in addition to the Gram-positive organisms for which study
medication therapy was used, aztreonam, piperacillin-tazobactam, and/or
metronidazole were allowed. The objective of each study was non-inferiority
of telavancin versus vancomycin in clinical cure rate at the test-of-cure
visit. Determination of clinical cure was based upon physician-judged
resolution of clinical signs and symptoms of NP. In both studies,
telavancin achieved the objective of non-inferiority in the all-treated
(AT) and clinically evaluable (CE) patient populations.
About the Telavancin Collaboration
In November 2005, Theravance entered into a collaboration arrangement with
Astellas Pharma Inc. 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 is responsible for the development of and U.S.
FDA filings for telavancin for the treatment of (i) complicated skin and
skin structure infections and (ii) nosocomial pneumonia. Theravance is also
responsible for the manufacture of approximately six months of first
commercial sale stock for launch of telavancin in the United States.
Astellas is responsible for all other development, regulatory,
manufacturing, sales and marketing activities. Theravance will collaborate
with Astellas in marketing in the United States for the first three years
following approval.
About Astellas Pharma Europe Ltd.
Astellas Pharma Europe Ltd., located in the UK, is a European subsidiary 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 company by combining
outstanding R&D and marketing capabilities and continuing to grow in the
world pharmaceutical market. Astellas Pharma Europe is responsible for 20
affiliate offices located across Europe, the Middle East and Africa, two
R&D sites and three manufacturing plants with approximately 3,400 staff.
For more information, please visit the company's web site at
www.astellas.eu.
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. The company's key
programs include: VIBATIV(TM) (telavancin) with Astellas Pharma Inc. and
the Horizon program and Bifunctional Muscarinic Antagonist-Beta2 Agonist
(MABA) program with GlaxoSmithKline plc. By leveraging its proprietary
insight of multivalency toward drug discovery, Theravance is pursuing a
next generation strategy designed to discover superior medicines in areas
of significant unmet medical need. For more information, please visit the
company's web site at www.theravance.com.
THERAVANCE®, the Theravance logo, and MEDICINES THAT MAKE A DIFFERENCE®
are registered trademarks of Theravance, Inc.
VIBATIV is a trademark of Astellas Pharma 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 and timing of clinical studies and
product commercialization, statements regarding the potential benefits and
mechanisms of action of drug candidates, statements concerning the timing
of seeking regulatory approval of our product candidates, statements
concerning enabling capabilities of Theravance's approach to drug discovery
and its proprietary insights, statements regarding 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, delays or failure to
achieve regulatory approvals for, or to successfully launch, product
candidates, risks of relying on third-party manufacturers for the supply of
our product candidates 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 Theravance's
Quarterly Report on Form 10-Q filed with the Securities and Exchange
Commission (SEC) on August 5, 2009 and the risks discussed in our other
periodic 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 Europe Ltd.
Percival Barretto-Ko
Executive Director, Corporate Strategy & Communications
+44-779-510-6305
Email Contact
Theravance, Inc.
Michael W. Aguiar
Senior Vice President and Chief Financial Officer
650-808-4100
Email Contact
