Theravance Announces FDA Approval of VIBATIV(R) (telavancin) for the Treatment of Hospital-Acquired and Ventilator-Associated

Theravance Announces FDA Approval of VIBATIV(R) (telavancin) for the Treatment 
of Hospital-Acquired and Ventilator-Associated Bacterial
Pneumonia 
SOUTH SAN FRANCISCO, CA -- (Marketwired) -- 06/21/13 --   Theravance,
Inc. (NASDAQ: THRX) today announced that the U.S. Food and Drug
Administration (FDA) has approved VIBATIV(R) (telavancin) for the
treatment of adult patients with hospital-acquired and
ventilator-associated bacterial pneumonia (HABP/VABP) caused by
susceptible isolates of Staphylococcus aureus when alternative
treatments are not suitable. VIBATIV(R), discovered and developed by
Theravance, 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. In 2009, VIBATIV(R) was approved in
the U.S. for the treatment of complicated skin and skin structure
infections (cSSSI) caused by susceptible isolates of Gram-positive
bacteria, including Staphylococcus aureus, both
methicillin-susceptible (MSSA) and methicillin-resistant (MRSA)
strains. 
"We are excited about the approval of VIBATIV(R) for this additional
indication, as it provides an important option for doctors in the
treatment of patients with life-threatening hospital-acquired
pneumonia caused by Staph. aureus, including MRSA," said Rick E
Winningham, Theravance's Chief Executive Officer. "Theravance plans
to make VIBATIV(R) available for purchase through wholesalers in the
third quarter of 2013 and is continuing to evaluate commercialization
alternatives for the U.S. market. I would like to thank the
Theravance team and the many external medical experts for their
dedication in bringing this important medicine back to market." 
"VIBATIV(R) will be a welcome addition for physicians treating
hospital-acquired bacterial pneumonia," said Ralph Corey, M.D.,
Professor of Medicine at the Duke University Medical Center and a
Principal Investigator for the studies that evaluated the safety and
efficacy of VIBATIV(R) in HABP/VABP. "Pneumonia is associated with
one of the highest mortality rates among hospital-acquired infections
and increases hospital stay and costs of care. MRSA pneumonia, in
particular, is an increasingly challenging infection as there are f
ew
approved treatments available today and resistance to current
antibiotics remains a problem. VIBATIV(R) offers effectiveness in
these difficult to treat infections when alternative therapies are
not suitable."  
About VIBATIV(R) (telavancin) 
VIBATIV(R) 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. VIBATIV(R) 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(R) is approved in the U.S.
for the treatment of adult patients with HABP/VABP when alternative
treatments are not suitable and cSSSI caused by susceptible isolates
of Gram-positive bacteria, including Staphylococcus aureus, both
methicillin-susceptible (MSSA) and methicillin-resistant (MRSA)
strains.  
About the Hospital-Acquired Bacterial Pneumonia Clinical Studies 
ATTAIN I and ATTAIN II were two large, multi-center, multinational,
double-blind, randomized Phase 3 clinical studies, in which 1,503
adult patients were enrolled and treated, 464 of whom were infected
with MRSA. Patients with HABP 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 gram IV every 12
hours. The objective of each study was non-inferiority of VIBATIV(R)
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 HABP.  
VIBATIV(R) Important Safety Information (U.S.) 
Mortality
 Patients
with pre-existing moderate/severe renal impairment (CrCl ≤50
mL/min) who were treated with VIBATIV(R) for hospital-acquired
bacterial pneumonia/ventilator-associated bacterial pneumonia had
increased mortality observed versus vancomycin. Use of VIBATIV(R) in
patients with pre-existing moderate/severe renal impairment (CrCl
≤50 mL/min) should be considered only when the anticipated
benefit to the patient outweighs the potential risk. 
Nephrotoxicity 
 New onset or worsening renal impairment occurred in
patients who received VIBATIV(R). Renal adverse events were more
likely to occur in patients with baseline comorbidities known to
predispose patients to kidney dysfunction and in patients who
received concomitant medications known to affect kidney function.  
Monitor renal function in all patients receiving VIBATIV(R) prior to
initiation of treatment, during treatment, and at the end of therapy.
If renal function decreases, the benefit of continuing VIBATIV(R)
versus discontinuing and initiating therapy with an alternative agent
should be assessed.  
Fetal Risk 
 Women of childbearing potential should have a serum
pregnancy test prior to administration of VIBATIV(R). Avoid use of
VIBATIV(R) during pregnancy unless the potential benefit to the
patient outweighs the potential risk to the fetus. Adverse
developmental outcomes observed in three animal species at clinically
relevant doses raise concerns about potential adverse developmental
outcomes in humans. If not already pregnant, women of childbearing
potential should use effective contraception during VIBATIV(R)
treatment.  
Contraindication
 VIBATIV(R) is contraindicated in
patients with a known hypersensitivity to the drug. 
Hypersensitivity Reactions
 Serious and potentially fatal
hypersensitivity reactions, including anaphylactic reactions, may
occur after first or subsequent doses. VIBATIV(R) should be used with
caution in patients with known hypersensitivity to vancomycin. 
Geriatric Use 
 Telavancin is substantially excreted by the kidney,
and the risk of adverse reactions may be greater in patients with
impaired renal function. Because elderly patients are more likely to
have decreased renal function, care should be taken in dose selection
in this age group.  
Infusion Related Reactions 
 VIBATIV(R) is a lipoglycopeptide
antibacterial agent and should be administered over a period of 60
minutes to reduce the risk of infusion-related reactions. Rapid
intravenous infusions of the glycopeptide class of antimicrobial
agents can cause "Red-man Syndrome" like reactions including:
flushing of the upper body, urticaria, pruritus, or rash.  
QTc Prolongation 
 Caution is warranted when prescribing VIBATIV(R)
to patients taking drugs known to prolong the QT interval. In a study
involving healthy volunteers, VIBATIV(R) prolonged the QTc interval.
Use of VIBATIV(R) should be avoided in patients with congenital long
QT syndrome, known prolongation of the QTc interval, uncompensated
heart failure, or severe left ventricular hypertrophy.  
Most Common Adverse Reactions 
 The most common adverse reactions
(greater than or equal to 10% of patients treated with VIBATIV(R))
were diarrhea, taste disturbance, nausea, vomiting, and foamy urine.  
Full Prescribing Information, including Boxed Warning and Medication
Guide in the U.S., will be available soon at www.VIBATIV.com. 
About Theravance 
Theravance is a biopharmaceutical company with a pipeline of
internally discovered pro
duct candidates and strategic collaborations
with pharmaceutical companies. 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 central nervous system (CNS)/pain.
Theravance's key programs include: RELVAR(TM) ELLIPTA(TM) or BREO(TM)
ELLIPTA(TM) (FF/VI), ANORO(TM) ELLIPTA(TM) (UMEC/VI) and MABA
(Bifunctional Muscarinic Antagonist-Beta2 Agonist), each partnered
with GlaxoSmithKline plc, and its oral Peripheral Mu Opioid Receptor
Antagonist program. By leveraging its proprietary insight of
multivalency to drug discovery, Theravance is pursuing a
best-in-class strategy designed to discover superior medicines in
areas of significant unmet medical need. For more information, please
visit Theravance's web site at www.theravance.com. 
THERAVANCE(R), the Theravance logo, and MEDICINES THAT MAKE A
DIFFERENCE(R) are registered trademarks of Theravance, Inc.  
VIBATIV(R) is a registered trademark of Theravance, Inc. 
RELVAR(TM), BREO(TM), ANORO(TM) and ELLIPTA(TM) are trademarks of the
GlaxoSmithKline group of companies. The use of the brand names
ANORO(TM) and RELVAR(TM) has not yet been approved by any regulatory
authority. 
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 Securities Exchange Act of 1934 and the Private Securities
Litigation Reform Act of 1995. Examples of such statements include
statements relating to: the status and timing of clinical studies,
data analysis and communication of results, the potential benefits
and mechanisms of action of product candidates, the enabling
capabilities of Theravance's approach to drug discovery and its
proprietary insights, expectations for product candidates through
development and commercialization, and the timing of seeking
regulatory approval of product candidates. 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 the 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: the potential
that results from clinical or non-clinical studies indicate product
candidates are unsafe or ineffective, our dependence on third parties
to conduct our clinical studies, delays or failure to achieve
regulatory approvals for product candidates, and risks of
collaborating with third parties to discover, develop and
commercialize products. Other risks affecting Theravance are
described under the heading "Risk Factors" contained in Theravance's
Quarterly Report on Form 10-Q filed with the Securities and Exchange
Commission (SEC) on May 1, 2013 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. 
(THRX-G) 
Contact Information: 
Michael W. Aguiar
Senior Vice President and Chief Financial Officer
650-808-4100 
investor.relations@theravance.com 
 
 
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