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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
____________
FORM
8-K
____________
Current
Report Pursuant
to
Section 13 or 15(d) of the
Securities
Exchange Act of 1934
Date
of
Report (Date of earliest event Reported): July 9, 2007
____________
THERAVANCE,
INC.
(Exact
Name of Registrant as Specified in its Charter)
____________
|
Delaware
|
000-30319
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94-3265960
|
|
(State
or Other Jurisdiction of Incorporation)
|
(Commission
File Number)
|
(I.R.S.
Employer Identification Number)
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901
Gateway Boulevard
South
San Francisco, California 94080
(650)
808-6000
(Addresses,
including zip code, and telephone numbers, including area code, of principal
executive offices)
____________
Check
the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions (see General Instruction A.2. below):
|
o
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Written
communications pursuant to Rule 425 under the Securities Act (17
CFR
230.425)
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o
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
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o
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act
(17 CFR
240.14d-2(b))
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|
o
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act
(17 CFR
240.13e-4(c))
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Item
7.01.
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Regulation
FD Disclosure.
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The
information in this Current Report (including Exhibit 99.1) is being furnished
and shall not be deemed “filed” for the purposes of Section 18 of the Securities
Exchange Act of 1934, as amended, or otherwise subject to the liabilities
of
that Section. The information in this Current Report (including Exhibit 99.1)
shall not be incorporated by reference into any registration statement or
other
document pursuant to the Securities Act of 1933, as amended, except as shall
be
expressly set forth by specific reference in such filing.
On
July 9, 2007, Theravance, Inc.
issued a press release regarding results from its Phase 2 clinical study
of its
investigational antibiotic TD-1792. A copy of the press release is
furnished as Exhibit 99.1 to this Current Report.
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Item
9.01.
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Financial
Statements and Exhibits.
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(d)
Exhibits.
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99.1
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Press
Release of Theravance, Inc. dated July 9,
2007
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SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
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THERAVANCE,
INC.
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Date: July
9, 2007
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By:
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/s/
Rick E Winningham
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Rick
E Winningham
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Chief
Executive Officer
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EXHIBIT
INDEX
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Exhibit
No.
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Exhibit
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Press
Release of Theravance, Inc. dated July 9,
2007
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Theravance
Announces Positive Results From Phase 2 Clinical Study with Investigational
Antibiotic in Patients with Complicated Skin and Skin Structure
Infections
TD-1792
Achieves Primary Endpoint
SOUTH
SAN FRANCISCO, CA/July 9, 2007 –
Theravance, Inc. (NASDAQ: THRX) today announced results from its large Phase
2
clinical study evaluating the safety and efficacy of its investigational
antibiotic, TD-1792, in the treatment of complicated skin and skin structure
infections (cSSSI) caused by Gram-positive bacteria, including resistant strains
such as methicillin-resistant Staphylococcus aureus
(MRSA). The study met its primary endpoint of non-inferiority
compared to vancomycin, the standard of care for resistant Gram-positive
infections, in the clinically evaluable population, and also met key secondary
endpoints.
Clinical
cure rates in the clinically evaluable population were 91.7% for patients
treated with TD-1792 (77/84) and 90.7% for patients treated with vancomycin
(78/86). Clinical cure rates in the clinically evaluable population
for patients with confirmed MRSA infections were 94.7% for patients treated
with
TD-1792 (36/38) and 91.9% for patients treated with vancomycin
(34/37). In the all-treated population, clinical cure rates for
patients treated with TD-1792 and standard therapy, respectively, were 80.6%
(79/98) versus 82.8% (82/99). In the group of microbiologically
evaluable patients, eradication was achieved in 93.7% of the group treated
with
TD-1792 (59/63) versus 92.1% in the group receiving vancomycin
(58/63).
The
overall incidence and severity of adverse events were similar in the TD-1792
and
standard therapy groups. There were no serious adverse events
reported in the TD-1792 group compared with two in the vancomycin
group. Fewer patients receiving TD-1792 (n=2) discontinued treatment
due to an adverse event compared with vancomycin (n=5). The most
common adverse events in both treatment groups included headache, nausea, small
increases in liver enzymes (ALT, AST), and pruritus.
“We
are
extremely pleased with the results of our Phase 2 clinical study of this highly
potent compound,” said Michael Kitt, MD, Senior Vice President of Development at
Theravance. “In particular, the favorable tolerability trends of
TD-1792 confirm our decision to explore higher doses in our ongoing Phase 1
program. We believe that the results of this study allow us to pursue
more serious infections, such as bacteremia.”
About
the Study
The
study
was randomized, double-blind, active-controlled and conducted in the United
States comparing safety, efficacy, and tolerability of once-daily TD-1792 to
twice-daily vancomycin, the standard of care for resistant Gram-positive
infections, in patients with cSSSI caused by Gram-positive bacteria, including
resistant strains such as MRSA. One hundred and ninety-seven patients
were randomized and received study medication with either 2 mg/kg TD-1792 dosed
once daily or vancomycin dosed 1 gram twice daily for up to 14
days. Aztreonam and/or metronidazole was added for Gram-negative or
anaerobic coverage. A test-of cure-visit was conducted between 7 and
14 days following the last day of treatment. The primary endpoint was
clinical cure for the clinically evaluable population at the test-of-cure
visit.
Study
populations for the results cited above were described as follows:
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·
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All
Treated (AT): patients received at least one dose of study
medication
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·
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Clinically
Evaluable (CE): patients fulfilled all protocol criteria
(inclusion/exclusion criteria, duration of therapy &
evaluations)
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·
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Microbiologically
Evaluable (ME): Clinically Evaluable patients with
microbiological confirmation of
pathogen(s)
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About
TD-1792
TD-1792
is a highly potent, bactericidal, once-daily antibiotic discovered by Theravance
through the application of multivalency. The goal of the TD-1792
clinical program is to develop a next-generation antibiotic with a better
therapeutic index than vancomycin for the treatment of serious infections caused
by MRSA. In preclinical in vitro studies, TD-1792 demonstrated marked
bactericidal activity and was approximately 30-fold more potent than vancomycin
against MRSA and approximately 100-fold more potent than oxacillin against
methicillin-sensitive Staphylococcus aureus (MSSA).
Astellas
Option
Astellas
Pharma Inc. has an option to license TD-1792 for further development and
commercialization on substantially the same terms under which Astellas has
licensed telavancin. For additional information regarding the
collaboration agreement with Astellas, please refer to SEC filings on the
investor relations portion of Theravance's website at
www.theravance.com.
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. Of the five programs in development, four are
in late stage – its telavancin program focusing on treating serious
Gram-positive bacterial infections in collaboration with Astellas Pharma Inc.,
its Gastrointestinal Motility Dysfunction program, the Beyond Advair
collaboration with GlaxoSmithKline, and TD-1792 for the treatment of serious
Gram-positive infections. 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.
Conference
Call and Webcast Information
Theravance
has scheduled a conference call to discuss this announcement today at 5:00
p.m.
Eastern Daylight Time. To participate in the live call, please dial
888-802-2266 from the U.S. and Canada, or 913-312-1270 for international
callers. The live webcast can be accessed from Theravance's web site
at www.theravance.com. 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 and webcast will be available on the company's web site
for 30 days through Wednesday, August 8, 2007. An audio replay will
also be available through 11:59 p.m. Eastern Daylight Time on July 23, 2007
by
dialing 888-203-1112 from the U.S., or 719-457-0820 for international callers,
and entering passcode 1043658.
THERAVANCE®,
the Theravance logo, and MEDICINES THAT MAKE A DIFFERENCE® are registered
trademarks of Theravance, Inc.
This
press release contains and the conference call will contain 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 and 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, 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 the conference call 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 May 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:
Allison
Parker, Director, Investor Relations
650-808-4100
investor.relations@theravance.com
David
Brinkley, Senior Vice President, Commercial Development
650-808-3784
dbrinkley@thervance.com