Teva Pharmaceutical Industries Ltd., (NYSE and TASE:TEVA) today
announced the launch of an authorized generic of Cubicin®1
(daptomycin for injection) 500 mg per vial in the United
States.
Daptomycin for injection is an antibacterial drug indicated in
adults for the treatment of complicated skin and skin structure
infections (cSSSI) caused by susceptible isolates of the following
Gram-positive bacteria: Staphylococcus aureus (including
methicillin-resistant isolates), Streptococcus pyogenes,
Streptococcus agalactiae, Streptococcus dysgalactiae subspecies
equisimilis, and Enterococcus faecalis (vancomycin-susceptible
isolates only).
Daptomycin for injection is indicated in adults for the
treatment of Staphylococcus aureus bloodstream infections
(bacteremia), including those with right-sided infective
endocarditis, caused by methicillin-susceptible and
methicillin-resistant isolates.
Daptomycin for injection is not indicated for the treatment of
pneumonia. Daptomycin for injection is not indicated for the
treatment of left-sided infective endocarditis (LIE) due to S.
aureus. Daptomycin for injection has not been studied in patients
with prosthetic valve endocarditis.
To reduce the development of drug-resistant bacteria and
maintain the effectiveness of daptomycin for injection and other
antibacterial drugs, daptomycin for injection should be used only
to treat infections that are proven or strongly suspected to be
caused by susceptible bacteria. When culture and susceptibility
information is available, it should be considered in selecting or
modifying antibacterial therapy. In the absence of such data, local
epidemiology and susceptibility patterns may contribute to the
empiric selection of therapy. Empiric therapy may be initiated
while awaiting test results.
Teva remains committed to strengthening its generic injectable
business globally with continued investment in newer, higher-value
generic injectable products. Teva currently has 338 product
registrations pending FDA approval and holds the leading position
in first-to-file opportunities, with over 100 pending
first-to-files in the U.S. Currently, 1-in-5 generic prescriptions
dispensed in the U.S. is filled with a Teva generic product.
Daptomycin for injection had annual sales of approximately $1.2
billion in the United States, according to IMS data as of July
2016.
Selected Important Safety Information
Anaphylaxis/hypersensitivity reactions, which may be
life-threatening, have been reported with daptomycin for injection
use. If an allergic reaction occurs, discontinue daptomycin for
injection and treat appropriately.
Myopathy and rhabdomyolysis have been reported with
daptomycin for injection use. Monitor for muscle pain or weakness,
particularly of the distal extremities. Monitor creatine
phosphokinase (CPK) levels weekly and more frequently in patients
with CPK elevations while on daptomycin for injection treatment and
in those who received recent prior or concomitant HMG-CoA reductase
inhibitors. In patients with renal impairment, monitor renal
function and CPK levels more than once weekly. Discontinue
daptomycin for injection in patients with unexplained signs and
symptoms of myopathy with CPK levels >1,000 U/L (~5× ULN), and
in patients without symptoms and CPK levels >2,000 U/L (≥10×
ULN). In addition, consider temporarily suspending agents
associated with rhabdomyolysis, such as HMG-CoA reductase
inhibitors.
Eosinophilic pneumonia has been reported with daptomycin
for injection use. Promptly evaluate patients who develop fever,
dyspnea with hypoxic respiratory insufficiency, and diffuse
pulmonary infiltrates and discontinue daptomycin for injection
immediately. Treatment with systemic steroids is recommended.
Recurrence of eosinophilic pneumonia upon re-exposure has been
reported.
Peripheral neuropathy has been reported with daptomycin
for injection use. Monitor for signs and symptoms of peripheral
neuropathy.
Potential nervous and/or muscular system effects in patients
younger than 12 months: Avoid use of daptomycin for injection
in patients younger than 12 months due to the risk of potential
effects on muscular, neuromuscular, and/or nervous systems (either
peripheral and/or central) observed in neonatal dogs.
Clostridium difficile-associated diarrhea (CDAD),
ranging from mild diarrhea to fatal colitis, has been reported with
nearly all systemic antibacterial agents, including daptomycin for
injection. Evaluate all patients who present with diarrhea
following antibacterial use. Careful medical history is necessary
because CDAD has been reported to occur more than two months after
the administration of antibacterial agents. If CDAD is suspected or
confirmed, antibacterial use not directed against C. difficile
should be discontinued, if possible.
Patients with persisting or relapsing S. aureus
bacteremia/endocarditis, possibly due to reduced daptomycin
susceptibility, or poor clinical response should have repeat blood
cultures. Appropriate surgical intervention and/or change in
antibacterial regimen may be required. Failure of treatment due to
persisting or relapsing S. aureus bacteremia/endocarditis may be
due to reduced daptomycin susceptibility.
In the cSSSI and S. aureus bacteremia/endocarditis trials,
decreased efficacy was observed in daptomycin for injection-treated
patients with moderate baseline renal impairment (CrCL
<50 mL/min).
Adverse Reactions: The most clinically significant
adverse reactions observed with daptomycin for injection 4 mg/kg
(cSSSI trials) and 6 mg/kg (S. aureus bacteremia/endocarditis
trial) were abnormal liver function tests, elevated CPK, and
dyspnea.
CrCL=creatinine clearance;
HMG-CoA=3-hydroxy-3-methylglutaryl-coenzyme A;
ULN=upper limit of normal.
For more information, please see the accompanying Full
Prescribing Information.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a
leading global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions used by millions of patients
every day. Headquartered in Israel, Teva is the world’s largest
generic medicines producer, leveraging its portfolio of more than
1,800 molecules to produce a wide range of generic products in
nearly every therapeutic area. In specialty medicines, Teva has a
world-leading position in innovative treatments for disorders of
the central nervous system, including pain, as well as a strong
portfolio of respiratory products. Teva integrates its generics and
specialty capabilities in its global research and development
division to create new ways of addressing unmet patient needs by
combining drug development capabilities with devices, services and
technologies. Teva's net revenues in 2015 amounted to $19.7
billion. For more information, visit www.tevapharm.com.
Teva's Safe Harbor Statement under the U. S. Private
Securities Litigation Reform Act of 1995:
This release contains forward-looking statements, which are
based on management’s current beliefs and expectations and involve
a number of known and unknown risks and uncertainties that could
cause our future results, performance or achievements to differ
significantly from the results, performance or achievements
expressed or implied by such forward-looking statements. Important
factors that could cause or contribute to such differences include
risks relating to: our ability to develop and commercialize
additional pharmaceutical products; competition for our specialty
products, especially Copaxone® (which faces competition from
orally-administered alternatives and a generic version); our
ability to integrate Allergan plc’s worldwide generic
pharmaceuticals business (“Actavis Generics”) and to realize the
anticipated benefits of the acquisition (and the timing of
realizing such benefits); the fact that following the consummation
of the Actavis Generics acquisition, we are dependent to a much
larger extent than previously on our generic pharmaceutical
business; potential restrictions on our ability to engage in
additional transactions or incur additional indebtedness as a
result of the substantial amount of debt incurred to finance the
Actavis Generics acquisition; the fact that for a period of time
following the Actavis Generics acquisition, we will have
significantly less cash on hand than previously, which could
adversely affect our ability to grow; the possibility of material
fines, penalties and other sanctions and other adverse consequences
arising out of our ongoing FCPA investigations and related matters;
our ability to achieve expected results from investments in our
pipeline of specialty and other products; our ability to identify
and successfully bid for suitable acquisition targets or licensing
opportunities, or to consummate and integrate acquisitions; the
extent to which any manufacturing or quality control problems
damage our reputation for quality production and require costly
remediation; increased government scrutiny in both the U.S. and
Europe of our patent settlement agreements; our exposure to
currency fluctuations and restrictions as well as credit risks; the
effectiveness of our patents, confidentiality agreements and other
measures to protect the intellectual property rights of our
specialty medicines; the effects of reforms in healthcare
regulation and pharmaceutical pricing, reimbursement and coverage;
competition for our generic products, both from other
pharmaceutical companies and as a result of increased governmental
pricing pressures; governmental investigations into sales and
marketing practices, particularly for our specialty pharmaceutical
products; adverse effects of political or economic instability,
major hostilities or acts of terrorism on our significant worldwide
operations; interruptions in our supply chain or problems with
internal or third-party information technology systems that
adversely affect our complex manufacturing processes; significant
disruptions of our information technology systems or breaches of
our data security; competition for our specialty pharmaceutical
businesses from companies with greater resources and capabilities;
the impact of continuing consolidation of our distributors and
customers; decreased opportunities to obtain U.S. market
exclusivity for significant new generic products; potential
liability in the U.S., Europe and other markets for sales of
generic products prior to a final resolution of outstanding patent
litigation; our potential exposure to product liability claims that
are not covered by insurance; any failure to recruit or retain key
personnel, or to attract additional executive and managerial
talent; any failures to comply with complex Medicare and Medicaid
reporting and payment obligations; significant impairment charges
relating to intangible assets, goodwill and property, plant and
equipment; the effects of increased leverage and our resulting
reliance on access to the capital markets; potentially significant
increases in tax liabilities; the effect on our overall effective
tax rate of the termination or expiration of governmental programs
or tax benefits, or of a change in our business; variations in
patent laws that may adversely affect our ability to manufacture
our products in the most efficient manner; environmental risks; and
other factors that are discussed in our Annual Report on Form 20-F
for the year ended December 31, 2015 and in our other filings with
the U.S. Securities and Exchange Commission (the "SEC").
Forward-looking statements speak only as of the date on which they
are made and we assume no obligation to update or revise any
forward-looking statements or other information, whether as a
result of new information, future events or otherwise.
1 Cubicin® is a registered trademark of Merck Sharp & Dohme
Corp.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160915005532/en/
Teva Pharmaceutical Industries Ltd.IR:United StatesKevin C.
Mannix, 215-591-8912orRan Meir,
215-591-3033orIsraelTomer Amitai, 972 (3)
926-7656orPR:IsraelIris Beck Codner, 972 (3)
926-7687orUnited StatesDenise Bradley, 215-591-8974
Teva Pharmaceutical Indu... (NYSE:TEVA)
Graphique Historique de l'Action
De Juin 2024 à Juil 2024
Teva Pharmaceutical Indu... (NYSE:TEVA)
Graphique Historique de l'Action
De Juil 2023 à Juil 2024