Teva Launches Authorized Generic of Cubicin®

JERUSALEM–(BUSINESS WIRE)–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.