DUBLIN, April 18, 2017 /PRNewswire/ -- Theravance
Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma" or the
"Company") today announced that data from new studies of
VIBATIV® (telavancin) will be presented at the
27th European Congress of Clinical Microbiology and Infectious
Diseases (ECCMID) in Vienna,
Austria, April 22 – 25, 2017.
Researchers will present preliminary data on clinical response
rates for patients enrolled in the ongoing Telavancin Observational
Use Registry (TOUR™) study. TOUR is designed to report
how telavancin is being used by healthcare practitioners to treat
patients in real-world clinical settings.
Additional presentations will include data from studies
evaluating the in vitro and in vivo potency of
VIBATIV against several challenging Staphylococcus aureus (S.
aureus) pathogens as compared to other commercialized
antibiotics. Pathogens examined in these studies include
difficult-to-treat methicillin-resistant and
methicillin-susceptible S. aureus (MRSA and MSSA) strains.
Researchers will also present findings from a study evaluating the
pharmacokinetics of VIBATIV in obese subjects.
Details of the VIBATIV poster presentations at
27th ECCMID are as follows:
Poster
#P1803:
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Complicated Skin and
Skin Structure Infections Treated in the Telavancin
Observational Use Registry (TOUR)
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Tuesday, April 25,
2017, 12:30 p.m. (local time)
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Session: Skin and
Soft Tissue Infections
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Poster
#P1814:
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Clinical Experience
with Telavancin for the Treatment of Patients
with Bone and Joint Infections: Preliminary Results from the
Telavancin
Observational Use Registry (TOUR)
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Tuesday, April 25,
2017, 12:30 p.m. (local time)
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Session: Progress in
Joint and Bone Infections
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Poster
#P0060:
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Lower Respiratory
Tract Infections in the Telavancin Observational Use
Registry (TOUR)
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Saturday, April 22,
2017, 3:30 p.m. (local time)
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Session:
Community-acquired Respiratory Infections
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Poster
#P1356:
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Telavancin Activity
Against a Global Collection of Staphylococcus aureus
Clinical Isolates (2013-2015)
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Monday, April 24,
2017, 12:30 p.m. (local time)
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Session: Drugs
Against Gram-positives – More Data
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Poster
#EP0948:
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Comparative
Pharmacokinetics/Pharmacodynamics (PK/PD) of Telavancin
and Vancomycin in the Murine Thigh and Lung Infection Models
Against Staphylococcus aureus (SA)
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Tuesday, April 25,
2017, 12:35 p.m. (local time)
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Session: Recent
Advances in PK/PD: Efficacy and Toxicity
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Poster
#EP0348:
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Pharmacokinetics of
Fixed Dose Telavancin in Obese and Non-Obese Adult
Subjects
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Sunday, April 23,
2017, 12:30 p.m. (local time)
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Session: Tissue
Penetration and Optimized Dosing in Special Patient
Populations
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About VIBATIV®
(telavancin)
VIBATIV® was discovered internally in a
research program dedicated to finding new antibiotics for serious
infections due to Staphylococcus aureus (S. aureus)
and other Gram-positive bacteria, including MRSA and MSSA. VIBATIV
is a once-daily, injectable lipoglycopeptide antibiotic with in
vitro potency, bactericidal activity within six hours, and
penetration into target infection sites. The drug's proven efficacy
against difficult-to-treat Gram-positive infections has been
demonstrated in several large, multinational registrational
studies, which involved one of the largest cohorts of patients with
S. aureus infections studied to date. Additionally, there is
extensive and well-documented evidence of the drug's in
vitro potency and in vivo activity against a broad
collection of Gram-positive bacterial pathogens, including those
that are considered difficult-to-treat and multidrug-resistant.
VIBATIV is approved in the U.S. for the treatment of
adult patients with hospital-acquired and ventilator-associated
bacterial pneumonia (HABP/VABP) caused by susceptible isolates of
S. aureus when alternative treatments are not suitable. In
addition, VIBATIV is approved in the U.S. for the treatment of
adult patients with complicated skin & skin structure
infections (cSSSI) caused by susceptible isolates of Gram-positive
bacteria, including S. aureus, both methicillin-susceptible
(MSSA) and methicillin-resistant (MRSA) strains. The product
labeling also describes the use of VIBATIV in treating
patients with concurrent bacteremia (in addition to either skin
infection or pneumonia).
VIBATIV is also approved for marketing in Europe, Canada and Russia. Theravance Biopharma plans to market
VIBATIV outside the U.S. through a network of partners. To
date, the company has secured partners for VIBATIV in the following
geographies – Canada, Middle East, North
Africa, Israel,
Russia, China and India.
VIBATIV® Important Safety
Information
Mortality
Patients with pre-existing moderate/severe renal impairment (CrCl
≤50 mL/min) who were treated with VIBATIV® for
hospital-acquired bacterial pneumonia/ventilator-associated
bacterial pneumonia had increased mortality observed versus
vancomycin. Use of VIBATIV 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. 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 prior to initiation of treatment,
during treatment, and at the end of therapy. If renal function
decreases, the benefit of continuing VIBATIV 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. Avoid use of VIBATIV 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 treatment.
Contraindication
Intravenous unfractionated heparin sodium is contraindicated with
VIBATIV administration due to artificially prolonged activated
partial thromboplastin time (aPTT) test results for up to 18 hours
after VIBATIV administration.
VIBATIV 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 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 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 to patients taking
drugs known to prolong the QT interval. In a study involving
healthy volunteers, VIBATIV prolonged the QTc interval. Use of
VIBATIV 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) were diarrhea, taste disturbance,
nausea, vomiting, and foamy urine.
Full Prescribing Information, including Boxed Warning and
Medication Guide in the U.S., is available at
www.VIBATIV.com.
About Theravance Biopharma
Theravance Biopharma is a diversified biopharmaceutical company
with the core purpose of creating medicines that help improve the
lives of patients suffering from serious illness.
Our pipeline of internally discovered product candidates
includes potential best-in-class medicines to address the unmet
needs of patients being treated for serious conditions primarily in
the acute care setting. VIBATIV® (telavancin), our first commercial
product, is a once-daily dual-mechanism antibiotic approved in the
U.S., Europe and certain other
countries for certain difficult-to-treat infections. Revefenacin
(TD-4208) is a long-acting muscarinic antagonist (LAMA) being
developed as a potential once-daily, nebulized treatment for
chronic obstructive pulmonary disease (COPD). Our neprilysin (NEP)
inhibitor program is designed to develop selective NEP inhibitors
for the treatment of a range of major cardiovascular and renal
diseases, including acute and chronic heart failure, hypertension
and chronic kidney diseases, such as diabetic nephropathy. Our
research efforts are focused in the areas of inflammation and
immunology, with the goal of designing medicines that provide
targeted drug delivery to tissues in the lung and gastrointestinal
tract in order to maximize patient benefit and minimize risk. The
first program to emerge from this research is designed to develop
intestinally restricted-targeted pan-Janus kinase (JAK) inhibitors
for the treatment of a range of inflammatory intestinal
diseases.
In addition, we have an economic interest in future payments
that may be made by Glaxo Group Limited or one of its affiliates
(GSK) pursuant to its agreements with Innoviva, Inc. relating to
certain drug development programs, including the Closed Triple (the
combination of fluticasone furoate, umeclidinium, and vilanterol),
currently in development for the treatment of COPD and asthma.
For more information, please visit www.theravance.com.
THERAVANCE®, the Cross/Star logo, and VIBATIV® are registered
trademarks of the Theravance Biopharma group of companies.
Trademarks, trade names or service marks of other companies
appearing on this press release are the property of their
respective owners.
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, expectations and
future events. Theravance Biopharma 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 Company's strategies, plans and
objectives, the Company's regulatory strategies and timing of
clinical studies, the potential benefits and mechanisms of action
of the Company's product and product candidates, the Company's
expectations for product candidates through development, potential
regulatory approval and commercialization (including their
potential as components of combination therapies) and the Company's
expectations for product sales. These statements are based on the
current estimates and assumptions of the management of Theravance
Biopharma as of the date of the press release and are subject to
risks, uncertainties, changes in circumstances, assumptions and
other factors that may cause the actual results of Theravance
Biopharma 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:
delays or difficulties in commencing or completing clinical
studies, the potential that results from clinical or non-clinical
studies indicate the Company's product candidates are unsafe or
ineffective (including when our product candidates are studied in
combination with other compounds),the feasibility of undertaking
future clinical trials for our product candidates based on FDA
policies and feedback, dependence on third parties to conduct
clinical studies, delays or failure to achieve and maintain
regulatory approvals for product candidates, risks of collaborating
with or relying on third parties to discover, develop and
commercialize products, risks associated with establishing and
maintaining sales, marketing and distribution capabilities with
appropriate technical expertise and supporting infrastructure and
risks of developing an institutional customer mix for
VIBATIV® (telavancin) that meet the Company's plan for
the product. Other risks affecting Theravance Biopharma are
described under the heading "Risk Factors" contained in Theravance
Biopharma's Form 10-K filed with the Securities and Exchange
Commission (SEC) on March 1, 2017
and Theravance Biopharma's other filings with the SEC. In
addition to the risks described above and in Theravance Biopharma's
filings with the SEC, other unknown or unpredictable factors also
could affect Theravance Biopharma's results. No forward-looking
statements can be guaranteed and actual results may differ
materially from such statements. Given these uncertainties,
you should not place undue reliance on these forward-looking
statements. Theravance Biopharma assumes no obligation to update
its forward-looking statements on account of new
information, future events or otherwise, except as required by
law.
Contact Information:
Alexander Dobbin
Head of Investor Relations
650-808-4045
investor.relations@theravance.com
Tim Brons
Vida Strategic Partners (Media)
646-319-8981
tbrons@vidasp.com
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SOURCE Theravance Biopharma, Inc.