DUBLIN, June 5, 2017 /PRNewswire/ -- Theravance
Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma" or the
"Company") today announced the presentation of positive new data
from multiple studies of VIBATIV® (telavancin),
the Company's proprietary FDA-approved antibiotic. Study results
highlighted greater in vitro potency for VIBATIV against
difficult-to-treat Staphylococcus aureus (S. aureus)
pathogens, including those considered to be multidrug resistant
(MDR), as compared to other commercialized antibiotics. These data
were presented at ASM Microbe 2017, the annual meeting of the
American Society for Microbiology (ASM), which is being held in
New Orleans, June 1-5, 2017.
Highlights from the VIBATIV presentations at ASM Microbe
include:
Activity Against S. aureus Clinical Isolates Causing Skin
Infections or Pneumonia with Concomitant Bacteremia
Researchers collected and analyzed S. aureus clinical
isolates causing skin and skin-structure infections (SSSI) or
pneumonia with concomitant bacteremia in US hospitals from
2012-2016. Results from the study demonstrated that VIBATIV
possessed potent in vitro activity against this broad range
of S. aureus clinical isolates, including those classified
as methicillin-resistant and methicillin-susceptible (MRSA and
MSSA). 100% of the evaluated S. aureus clinical isolates,
regardless of their type and including those considered to be MDR,
were susceptible to VIBATIV with an MIC90 of 0.06 μg/mL.
Minimum inhibitory concentrations (MICs) are a measure used to
express in vitro activity of an antibiotic against a
pathogen. MIC90 is the antibiotic concentration at which
90% of isolates are inhibited.
Importantly, the findings demonstrated greater in vitro
activity for VIBATIV as compared to other well-known antibiotics
such as vancomycin, daptomycin, ceftaroline and linezolid.
Against subsets of isolates classified as MRSA, the MICs for
VIBATIV were 8-fold lower than daptomycin, 16-fold lower than
ceftaroline and 16- to 32-fold lower than vancomycin and linezolid.
For those isolates classified as MDR, defined as displaying a
resistance to three or more drug classes, the MICs for VIBATIV were
8-fold lower than daptomycin, 16- to 32-fold lower than vancomycin
and linezolid, and 32-fold lower than ceftaroline.
Activity Against Cystic Fibrosis-Associated S. aureus,
Including Ceftaroline-Resistant MRSA
Researchers collected and analyzed MRSA and MSSA cystic fibrosis
(CF) clinical strains from three different CF centers in the
US. Results from the study demonstrated that VIBATIV
possessed potent in vitro activity against both MRSA and
MSSA CF clinical strains, including those resistant to
ceftaroline. When compared to daptomycin, ceftaroline and
vancomycin, VIBATV showed the greatest in vitro
potency. MICs for VIBATIV were 8-fold lower than for
ceftaroline and daptomycin and 25-fold lower than for vancomycin
against the CF-associated S. aureus isolates that were
evaluated.
MRSA has a significant clinical impact on individuals with CF,
resulting in worse survival as compared to CF patients who have
never had MRSA.1 As such, CF-associated MRSA represents
an area of significant medical need.
1 Dasenbrook EC, Checkley W, Merlo CA, Konstan MW,
Lechtzin N, Boyle MP. Association Between Respiratory Tract
Methicillin-Resistant Staphylococcus aureus and Survival in Cystic
Fibrosis. JAMA.2010;303(23):2386-2392.
doi:10.1001/jama.2010.791.
"We continue to work aggressively to generate compelling data to
differentiate VIBATIV from other available antibiotics in some of
the healthcare industry's most troubling and difficult-to-treat
infection types. To this end, these latest data add to the
impressive collection of research that demonstrates that VIBATIV
has greater in vitro potency against a variety of MRSA and
MDR infections than many well-known antibiotic products," said
Frank Pasqualone, Chief Commercial
Operations Officer at Theravance Biopharma. "In an environment
clouded by the challenges of antibiotic resistance, we believe that
the in vitro potency of VIBATIV, coupled with its
demonstrated bactericidal activity, provides clinicians an
important antibiotic treatment option for some of their most
challenging cases, where indicated."
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-Q filed with the Securities and Exchange
Commission (SEC) on May 9, 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.