Theravance Announces Posting of Briefing Documents for FDA

Theravance Announces Posting of Briefing Documents for FDA
Anti-Infective Drugs Advisory Committee Meeting on VIBATIV(R)
(telavancin) 
SOUTH SAN FRANCISCO, CA -- (Marketwire) -- 11/27/12 --  Theravance,
Inc. (NASDAQ: THRX) today announced that the US Food and Drug
Administration (FDA) has posted on its website briefing documents for
the November 29, 2012 Anti-Infective Drugs Advisory Committee (AIDAC)
meeting. The AIDAC will be asked to review and discuss Theravance's
New Drug Application (NDA) for VIBATIV(R) (telavancin), a
bactericidal, once-daily injectable antibiotic, for the proposed
indication of nosocomial pneumonia (pneumonia contracted by
hospitalized patients), including ventilator-associated pneumonia,
caused by susceptible isolates of the following Gram-positive
bacteria: Staphylococcus aureus (including methicillin-susceptible
and -resistant isolates) or Streptococcus pneumonia (penicillin
susceptible strains). 
The Theravance Briefing Document and the FDA Briefing Document are
now available at
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Anti-InfectiveDrugsAdvisoryCommittee/ucm329476.htm. 
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
methicillin-resistant Staphylococcus aureus (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 United States for the treatment of
adult patients with complicated skin and skin structure infections
(cSSSI) caused by susceptible isolates of Gram-positive bacteria,
including Staphylococcus aureus, both MRSA and
methicillin-susceptible (MSSA) strains.  
VIBATIV(R) Important Safety Information (US) 
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 clin
ically 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. 
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. Clinical cure rates in telavancin-treated patients were
lower in patients with baseline CrCl ≤50 mL/min compared to
those with CrCl >50 mL/min. Consider these data when selecting
antibacterial therapy for use in patients with baseline
moderate/severe renal impairment.  
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.  
Clostridium difficile-Associated Diarrhea  
Clostridium difficile-associated diarrhea (CDAD) has been reported
with nearly all antibacterial agents and may range in severity from
mild diarrhea to fatal colitis. CDAD must be considered in all
patients who present with diarrhea following antibiotic use. 
Development of Drug-Resistant Bacteria 
Prescribing VIBATIV(R) in the absence of a proven or strongly
suspected bacterial infection is unlikely to provide benefit to the
patient and increases the risk of the development of drug-resistant
bacteria. As with other antibacterial drugs, use of VIBATIV(R) may
result in overgrowth of nonsusceptible organisms, including fungi.  
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. 
Coagulation Test Interference 
VIBATIV(R) does not interfere with coagulation, but does interfere
with certain tests used to monitor coagulation such as prothrombin
time, international normalized ratio, activated partial
thromboplastin time, activated clotting time, and coagulation based
factor Xa tests. Blood samples for these coagulation tests should be
collected as close as possible prior to a patient's next dose of
VIBATIV(R).  
Adverse Reactions 
The most common adverse reactions (≥10% of patients treated
with VIBATIV(R)) observed in the Phase 3 cSSSI clinical trials were
taste disturbance, nausea, vomiting, and foamy urine.  
In the Phase 3 cSSSI clinical trials, serious adverse events were
reported in 7% of patients treated with VIBATIV(R) and most commonly
included renal, respiratory, or cardiac events. Serious adverse
events were reported in 5% of vancomycin-treated patients, and most
commonly included cardiac, respiratory, or infectious events. 
For full Prescribing Information, including Boxed Warning and
Medication Guide in the U.S., please visit www.VIBATIV.com. 
About Theravance 
Theravance is a biopharmaceutical company with a pipeline of
internally discovered product 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) or Breo(TM) (FF/VI),
umeclidinium bromide/vilanterol (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.  
Relvar(TM) or Breo(TM) (FF/VI) is an investigational medicine and is
not currently approved anywhere in the world. Relvar(TM) and Breo(TM)
are trademarks of the GlaxoSmithKline group of companies. The
 use of
these brand names has not yet been approved by any regulatory
authority. 
VIBATIV(R) is a registered trademark of Theravance, 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 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, statements regarding the
potential benefits and mechanisms of action of drug candidates,
statements concerning the timing of seeking regulatory approval of
our product candidates, (including with respect to VIBATIV(R)
statements regarding any expectation that we will be able to respond
fully or adequately to FDA's requests using currently existing
clinical data and any expectation that the FDA will approve the
VIBATIV(R) NDA on the basis of existing preclinical and clinical data
or at all), statements concerning the enabling capabilities of
Theravance's approach to drug discovery and its proprietary insights,
statements concerning 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, risks related to delays or
difficulties in commencing or completing clinical studies, the
potential that results of clinical or non-clinical studies indicate
product candidates are unsafe or ineffective, our dependence on third
parties in the conduct of our clinical studies, delays or failure to
achieve regulatory approvals for product candidates, risks of relying
on third-party manufacturers for the supply of our product and
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 October 31, 2012 and
the risks discussed in our other period filings with 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: 
Michael W. Aguiar 
Senior Vice President and Chief Financial Officer
650-808-4100
investor.relations@theravance.com