DUBLIN, Jan. 23, 2017 /PRNewswire/ -- Theravance
Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma" or the
"Company") today reported new interim data from the Company's
ongoing Telavancin Observational Use Registry (TOUR™)
study in an oral presentation at the Society of Critical Care
Medicine's (SCCM) 46th Critical Care Congress. TOUR is
designed to assess how VIBATIV® (telavancin) is being
used by healthcare practitioners to treat patients in real-world
clinical settings. The presented findings, which focused on a
subset of registry patients with diagnoses of bacteremia or
infective endocarditis (IE) (n=45), demonstrated positive clinical
responses in 64.4% of patients, with 6.7% of patients failing
treatment and 28.9% considered non-evaluable. Positive
clinical response was defined as cure or improvement leading to
step-down oral therapy. The SCCM 46th Critical Care
Congress is being held in Honolulu,
HI on January 20-25,
2017.
As of September 30, 2016, 593
patients had been enrolled in the TOUR study, with 45 of those
having diagnoses of bacteremia or IE. In addition to clinical
response results for these 45 patients, researchers reported that
the pathogens causing bacteremia or IE in TOUR patients included
methicillin-resistant Staphylococcus aureus (S.
aureus) or MRSA (53% of patients), methicillin-susceptible
S. aureus or MSSA (13%), coagulase negative staphylococci
(9%), and enterococcus (7%), among others. For these
patients, the median VIBATIV daily dose and duration of treatment
were 750 mg and 14 days, respectively. VIBATIV was generally
well tolerated in these patients with adverse event type and
frequency similar to those reported in previous clinical
trials.
"We are pleased to see positive clinical response rates of
approximately 65% in these patients with bacteremia and infective
endocarditis. Based on these results, we believe that VIBATIV may
represent an alternative treatment option for these patients," said
Kerry Cleveland, M.D., Professor of
Medicine, University of Tennessee
Health Science Center and one of the presentation's
co-authors. "While the totality of data from TOUR will be
extremely valuable in understanding how VIBATIV is being or can be
used therapeutically, equally important will be the subsets of
results that we compile for specific patient and infection types,
such as those presented at SCCM."
"It is not surprising to see that a majority of the bacteremia
and infective endocarditis patients in TOUR had their infections
caused by S. aureus, which is the leading cause of
bacteremia and can result in serious secondary infections such as
IE. Importantly, S. aureus bacteremia represents a
significant unmet medical need and treatment failure is common with
the only two currently approved antibiotics," said Bruce Friedman, M.D., Critical Care and
Co-Director JM Still Burn Center, Professor of Medicine,
Anesthesiology and Perioperative at Medicine Medical College of Georgia and the presentation's
first author. "The latest data from TOUR on clinical response rates
adds to the large and growing collection of data that demonstrates
the activity of VIBATIV against S. aureus, including both
MRSA and MSSA strains. This provides support for the belief
that patients with infections caused by S. aureus are
potentially appropriate targets for VIBATIV treatment."
"The results reported at SCCM build upon the initial interim
TOUR data that were recently presented at IDWeek, which showed
comparable clinical response rates in bone and joint infections and
bacteremia, as well as the product's labeled indications.
Furthermore, in bacteremia patients, these latest TOUR findings are
in line with the data that was recently added to the VIBATIV label
for concurrent bacteremia in the drug's approved indications," said
Frank Pasqualone, Senior Vice
President and Global Head, Acute Care Business at Theravance
Biopharma. "TOUR continues to progress on schedule with more
than 900 patients enrolled to date and we look forward to
additional presentations of data from the study at future
scientific conferences."
TOUR is a multi-center, observational study designed to enroll
and report the treatment course of approximately 1,000 patients
from about 50 sites in the US. As a non-interventional study,
all treatment decisions are at the discretion of the patient's
healthcare provider. Study patients may have treatment
initiated in either hospital-based settings and out-patient
infusion sites. In order to qualify for enrollment in TOUR,
patients must have received at least one dose of VIBATIV and meet
specified inclusion criteria. By broadly collecting and
examining real-world data related to VIBATIV treatment patterns,
clinical effectiveness and safety outcomes in medical practice,
Theravance Biopharma aims to create an expansive knowledge base to
guide optimal clinical use and future development of the drug. More
than 900 of the 1,000 target patients have been enrolled to date.
Theravance Biopharma believes that results from TOUR may serve
several important objectives including:
- Assisting in optimizing use in patients currently being treated
with VIBATIV;
- Potentially highlighting subsets of patients that may be most
appropriate for treatment with VIBATIV; and
- Illustrating current healthcare practitioner's patterns of
VIBATIV use .
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 bactericidal, once-daily, injectable lipoglycopeptide
antibiotic with in vitro potency and a dual mechanism of
action that both inhibits bacterial cell wall synthesis and
disrupts bacterial cell membrane function. 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/or
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 (aPTTwq) 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 make a difference
in 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
GI-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
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, MEDICINES THAT MAKE
A DIFFERENCE® and VIBATIV® are registered
trademarks of the Theravance Biopharma group of companies.
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 and
results of clinical studies, the potential benefits and mechanisms
of action of the Company's product and product candidates and the
Company's expectations for product candidates through development,
potential regulatory approval and commercialization. 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, 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.
Other risks affecting Theravance Biopharma are described under the
heading "Risk Factors" contained in Theravance Biopharma's
Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission (SEC) on November 9,
2016. In addition to the risks described above and in
Theravance Biopharma's other 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:
Renee Gala
Chief Financial Officer
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.