Vibativ® is a life-saving
antibiotic for pneumonia and serious skin infections
Approval in China paves the way for launch in world's
second-largest market
NASHVILLE, Tenn. and SHANGHAI, Feb. 18,
2025 /PRNewswire/ -- Specialty pharmaceutical
companies Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) and
SciClone Pharmaceuticals (Holdings) Limited ("SciClone
Pharmaceuticals" or "SciClone") today announced the NMPA (National
Medical Products Administration) approval of Cumberland's Vibativ® (telavancin)
injection in China. The
announcement follows an agreement between the companies
providing SciClone the exclusive rights to register, promote
and distribute the product to patients in that country. The
NMPA is the Chinese pharmaceutical regulatory authority there,
equivalent to the United States'
Food and Drug Administration (FDA).
Vibativ is a potent, FDA-approved injectable anti-infective that
serves as a potentially life-saving treatment in patients with
hospital-acquired and ventilator-associated pneumonia resulting
from a range of Gram-positive bacterial pathogens, including those
that are considered difficult-to-treat and are multidrug-resistant.
Vibativ is also used for the treatment of complicated skin and skin
structure infections, such as MRSA. As a once-daily dosed
antibiotic, it does not require therapeutic drug monitoring,
decreasing health care professionals' exposure to the patient.
While many recently introduced antibiotics are quickly losing
the battle to fight the bacteria they were designed to kill because
those bacteria have become drug-resistant, Vibativ was specifically
designed to kill drug-resistant bacteria. Two published studies –
one that tested over 24,000 clinical isolates and one that tested
over 15,000 – show that Vibativ is just as potent today against
difficult-to-treat and multidrug-resistant bacteria as it was when
it was introduced over 10 years ago.
"Vibativ's life-saving potential for patients with certain
difficult-to-treat infections makes it an important addition to our
portfolio and supports our mission to provide quality medical
products that improve patient care," said Zhao Hong, Executive Director, President and CEO
of SciClone Pharmaceuticals. "We strongly believe in this product
and look forward to providing it to patients in China."
"SciClone has a strong distribution network throughout
China, and we are proud to partner
with them to introduce Vibativ for the benefit of patients in their
market," said A.J. Kazimi, CEO of Cumberland Pharmaceuticals. "We
are confident they will ensure the product reaches as many patients
within the country as possible."
SciClone and Cumberland plan to
launch Vibativ in China later this
year.
About Vibativ®
Vibativ® (telavancin) injection was discovered 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. It is a
once-daily, injectable lipoglycopeptide antibiotic with in
vitro potency, bactericidal activity within six hours and
penetration into patients' target infection sites.
The drug is approved in the U.S., China and Middle
East 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 for the treatment of adult
patients with complicated skin and skin structure infections
(cSSSI) caused by susceptible isolates of Gram-positive bacteria,
including S. aureus and both methicillin-susceptible (MSSA)
and methicillin-resistant (MRSA) strains.
The product labeling also describes the use of Vibativ in
treating patients whose pneumonia or skin infection is complicated
by concurrent bacteremia.
The product'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.
Importantly, these studies demonstrated significantly higher
cure rates for Vibativ as compared to vancomycin in HABP/VABP due
to any single Gram-positive pathogen or S. aureus with
vancomycin MIC ≥1 µg/mL.
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.
In October 2023, Cumberland announced a new publication in
Antimicrobial Agents and Chemotherapy detailing the results
of the first clinical study investigating the safety and
pharmacokinetics of Vibativ in children 2 to 17 years of age. The
results of the study suggest that a single dose of Vibativ is safe
in children and they experience reduced exposure to Vibativ,
compared with the same body weight-based dosing in adults.
For full prescribing information, including important safety
information visit www.vibativ.com.
About SciClone Pharmaceuticals
SciClone Pharmaceuticals (Holdings) Limited ("SciClone
Pharmaceuticals") is a global biopharmaceutical company with an
integrated platform for the development and commercialization of
innovative therapies for cancer and severe infection.
With an innovation-driven strategic transformation, SciClone
Pharmaceuticals has established a product portfolio with
differentiated advantages, including a number of first-in-class and
best-in-class potential products / pipelines. Staying true to its
original aspiration of "SciClone gives life hope," SciClone
Pharmaceuticals is dedicated to improving patients' health by
providing top-tier health care products and services with global
standards of care.
For more information regarding SciClone Pharmaceuticals, please
visit: www.sciclone.com.
About Cumberland Pharmaceuticals
Cumberland Pharmaceuticals Inc. is the largest
biopharmaceutical company founded and headquartered in Tennessee and is focused on providing unique
products that improve the quality of patient care. The company
develops, acquires, and commercializes products for the hospital
acute care, gastroenterology and oncology market segments.
Cumberland's portfolio
comprises six FDA-approved brands. The company also has a series of
Phase II clinical programs underway evaluating its ifetroban
product candidate in patients with cardiomyopathy associated with
Duchenne muscular dystrophy, Systemic Sclerosis and Idiopathic
Pulmonary Fibrosis.
For more information on Cumberland's approved products, including full
prescribing information, please visit links to the individual
product websites, which can be found on the company's website at
www.cumberlandpharma.com.
Forward-Looking Statements
This press release contains forward-looking statements, which
are subject to certain risks and reflect Cumberland's current views on future events
based on what it believes are reasonable assumptions. No assurance
can be given that these events will occur. As with any business,
all phases of Cumberland's
operations are subject to factors outside of its control, and any
one or combination of these factors could materially affect
Cumberland's results of
operations. These factors include market conditions, competition,
an inability of manufacturers to produce Cumberland's products on a timely basis,
failure of manufacturers to comply with regulations applicable to
pharmaceutical manufacturers, maintaining an effective sales and
marketing infrastructure, natural disasters, public health
epidemics, and other events beyond its control as more fully
discussed in the company's most recent Form 10-K and any additional
updates filed with the SEC. There can be no assurance that results
anticipated by the company will be realized or that they will have
the expected effects. Readers are cautioned not to place undue
reliance on forward-looking statements, which speak only as of the
date hereof. The company does not undertake any obligation to
publicly revise these statements to reflect events after the date
hereof.
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SOURCE Cumberland Pharmaceuticals Inc.
