Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA)
announced today that it has resolved its ongoing dispute with Amgen
over Teva’s generic cinacalcet HCl product. Teva and Amgen have
been involved in patent infringement litigation, and Teva recently
received approval for, and launched its generic product in the
US.
By virtue of the settlement, the litigation between the parties
will be ended and Teva has agreed to stop selling its generic
product until its license date in mid-year 2021, or earlier under
certain circumstances. Teva will pay Amgen an undisclosed amount as
part of the settlement. That amount and other terms of the
settlement remain confidential.
Cinacalcet is a calcium-sensing receptor agonist indicated for
secondary hyperparathyroidism (HPT) in adult patients with chronic
kidney disease on dialysis. It is also used for the treatment of
hypercalcemia in adult patients with parathyroid carcinoma and
severe hypercalcemia in adult patients with primary HPT who are
unable to undergo parathyroidectomy.
About Cinacalcet Hydrochloride Tablets
Cinacalcet hydrochloride tablets are indicated for the treatment
of secondary hyperparathyroidism (HPT) in adult patients with
chronic kidney disease (CKD) on dialysis. Important Limitations of
Use: cinacalcet hydrochloride tablets are NOT indicated for use in
patients with CKD who are not on dialysis because of an increased
risk of hypocalcemia.
Cinacalcet hydrochloride tablets are indicated for the treatment
of hypercalcemia in adult patients with Parathyroid Carcinoma.
Cinacalcet hydrochloride tablets are indicated for the treatment
of severe hypercalcemia in adult patients with primary HPT who are
unable to undergo parathyroidectomy.
IMPORTANT SAFETY
INFORMATION
Contraindications: Cinacalcet treatment initiation is
contraindicated if serum calcium is less than the lower limit of
the normal range.
Hypocalcemia: Cinacalcet lowers serum calcium and can
lead to hypocalcemia. Significant lowering of serum calcium can
cause paresthesias, myalgias, muscle spasms, tetany, seizures, QT
interval prolongation and ventricular arrhythmia. Life threatening
events and fatal outcomes associated with hypocalcemia have been
reported in patients treated with cinacalcet, including in
pediatric patients. The safety and effectiveness of cinacalcet have
not been established in pediatric patients.
Decreases in serum calcium can prolong the QT interval,
potentially resulting in ventricular arrhythmia. Cases of QT
prolongation and ventricular arrhythmia have been reported in
patients treated with cinacalcet. Patients with conditions that
predispose to QT interval prolongation and ventricular arrhythmia
may be at increased risk for QT interval prolongation and
ventricular arrhythmias if they develop hypocalcemia due to
cinacalcet. Closely monitor corrected serum calcium and QT interval
in patients, at risk, receiving cinacalcet.
In clinical studies, seizures were observed in
cinacalcet-treated patients. While the basis for the reported
seizure rate is not clear, the threshold for seizures is lowered by
significant reductions in serum calcium levels. Monitor serum
calcium levels in patients with seizure disorders receiving
cinacalcet.
Concurrent administration of cinacalcet with calcium-lowering
drugs including other calcium-sensing receptor agonists could
result in severe hypocalcemia. Closely monitor serum calcium in
patients receiving cinacalcet and concomitant therapies known to
lower serum calcium levels.
Patients with secondary HPT with CKD on
dialysis: Serum calcium and serum phosphorus should be
measured within 1 week and intact parathyroid hormone (iPTH) should
be measured 1 to 4 weeks after initiation or dose adjustment of
cinacalcet. Once the maintenance dose has been established, serum
calcium should be measured approximately monthly.
Patients with primary HPT or parathyroid
carcinoma: Serum calcium should be measured within 1 week
after initiation or dose adjustment of cinacalcet. Once maintenance
dose levels have been established, serum calcium should be measured
every 2 months.
Upper Gastrointestinal Bleeding: Cases of
gastrointestinal bleeding, mostly upper gastrointestinal bleeding,
have occurred in patients using calcimimetics, including
cinacalcet, from postmarketing and clinical trial sources. The
exact cause of GI bleeding in these patients is unknown.
Patients with risk factors for upper GI bleeding (such as known
gastritis, esophagitis, ulcers or severe vomiting) may be at
increased risk for GI bleeding when receiving cinacalcet treatment.
Monitor patients for worsening of common GI adverse reactions of
nausea and vomiting associated with cinacalcet and for signs and
symptoms of GI bleeding and ulcerations during cinacalcet therapy.
Promptly evaluate and treat any suspected GI bleeding.
Hypotension, Worsening Heart Failure and/or Arrhythmias:
In postmarketing safety surveillance, isolated, idiosyncratic cases
of hypotension, worsening heart failure, and/or arrhythmia have
been reported in patients with impaired cardiac function, in which
a causal relationship to cinacalcet could not be completely
excluded and which may be mediated by reductions in serum calcium
levels.
Adynamic Bone Disease: Adynamic bone disease may develop
if iPTH levels are suppressed below 100 pg/mL.
Drug Interactions with Strong CYP3A4 Inhibitors:
Cinacalcet is partially metabolized by CYP3A4. Dose adjustment of
cinacalcet may be required if a patient initiates or discontinues
therapy with a strong CYP3A4 inhibitor (e.g., ketoconazole,
itraconazole). The iPTH and serum calcium concentrations should be
closely monitored in these patients.
Drug Interactions with CYP2D6 Substrates: Cinacalcet is a
strong inhibitor of CYP2D6. Dose adjustments may be required for
concomitant medications that are predominantly metabolized by
CYP2D6 (e.g., desipramine, metoprolol, and carvedilol) and
particularly those with a narrow therapeutic index (e.g.,
flecainide and most tricyclic antidepressants).
Common Adverse Reactions: The most common adverse
reactions (i.e., incidence ≥25%) associated with cinacalcet were
nausea and vomiting.
Please see accompanying Full Prescribing
Information.
For more information, please see accompanying Full Prescribing
Information, including Boxed Warning. A copy may be requested from
Teva US Medical Information at 888-4-TEVA-USA (888-838-2872) or
druginfo@tevapharm.com, or Teva’s Public Relations or Investor
Relations contacts.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a
global leader in generic medicines, with innovative treatments in
select areas, including CNS, pain and respiratory. We deliver
high-quality generic products and medicines in nearly every
therapeutic area to address unmet patient needs. We have an
established presence in generics, specialty, OTC and API, building
on more than a century-old legacy, with a fully integrated R&D
function, strong operational base and global infrastructure and
scale. We strive to act in a socially and environmentally
responsible way. Headquartered in Israel, with production and
research facilities around the globe, we employ 45,000
professionals, committed to improving the lives of millions of
patients. Learn more at www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
regarding Teva's generic version of Sensipar®1, which are based on
management’s current beliefs and expectations and are subject to
substantial risks and uncertainties, both known and unknown, that
could cause our future results, performance or achievements to
differ significantly from that expressed or implied by such
forward-looking statements. Important factors that could cause or
contribute to such differences include risks relating to:
- The uncertainty of the commercial
success of our generic version of cinacalcet HCl.
- our ability to successfully compete in
the marketplace, including: that we are substantially dependent on
our generic products; competition for our specialty products,
especially COPAXONE®, our leading medicine, which faces competition
from existing and potential additional generic versions and
orally-administered alternatives; competition from companies with
greater resources and capabilities; efforts of pharmaceutical
companies to limit the use of generics including through
legislation and regulations; consolidation of our customer base and
commercial alliances among our customers; the increase in the
number of competitors targeting generic opportunities and seeking
U.S. market exclusivity for generic versions of significant
products; price erosion relating to our products, both from
competing products and increased regulation; delays in launches of
new products and our ability to achieve expected results from
investments in our product pipeline; our ability to take advantage
of high-value opportunities; the difficulty and expense of
obtaining licenses to proprietary technologies; and the
effectiveness of our patents and other measures to protect our
intellectual property rights;
- our substantially increased
indebtedness and significantly decreased cash on hand, which may
limit our ability to incur additional indebtedness, engage in
additional transactions or make new investments, and may result in
a further downgrade of our credit ratings; and our inability to
raise debt or borrow funds in amounts or on terms that are
favorable to us;
- our business and operations in general,
including: failure to effectively execute the restructuring plan
announced in December 2017; uncertainties related to, and failure
to achieve, the potential benefits and success of our new senior
management team and organizational structure; harm to our pipeline
of future products due to the ongoing review of our R&D
programs; our ability to develop and commercialize additional
pharmaceutical products; potential additional adverse consequences
following our resolution with the U.S. government of our FCPA
investigation; compliance with sanctions and other trade control
laws; manufacturing or quality control problems, which may damage
our reputation for quality production and require costly
remediation; interruptions in our supply chain; disruptions of our
or third party information technology systems or breaches of our
data security; the failure to recruit or retain key personnel;
variations in intellectual property laws that may adversely affect
our ability to manufacture our products; challenges associated with
conducting business globally, including adverse effects of
political or economic instability, major hostilities or terrorism;
significant sales to a limited number of customers in our U.S.
market; our ability to successfully bid for suitable acquisition
targets or licensing opportunities, or to consummate and integrate
acquisitions; and our prospects and opportunities for growth if we
sell assets;
- compliance, regulatory and litigation
matters, including: costs and delays resulting from the extensive
governmental regulation to which we are subject; the effects of
reforms in healthcare regulation and reductions in pharmaceutical
pricing, reimbursement and coverage; governmental investigations
into sales and marketing practices; potential liability for patent
infringement; product liability claims; increased government
scrutiny of our patent settlement agreements; failure to comply
with complex Medicare and Medicaid reporting and
payment obligations; and environmental risks;
- other financial and economic risks,
including: our exposure to currency fluctuations and restrictions
as well as credit risks; potential impairments of our intangible
assets; potential significant increases in tax liabilities; and 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;
- and other factors discussed in our
Annual Report on Form 10-K for the year ended December 31, 2017,
including in the section captioned “Risk Factors,” and in our other
filings with the U.S. Securities and Exchange Commission, which are
available at www.sec.gov and www.tevapharm.com. 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 contained herein, whether as a
result of new information, future events or otherwise. You are
cautioned not to put undue reliance on these forward-looking
statements.
1 Sensipar® is a registered trademark of Amgen, Inc.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190102005667/en/
IR ContactsUnited StatesKevin C. Mannix(215)
591-8912IsraelRan Meir(215) 591-3033PR
ContactsUnited StatesKelley Dougherty(973)
658-0237Elizabeth DeLuca(267) 468-4329IsraelYonatan Beker972
(54) 888 5898
Teva Pharmaceutical Indu... (NYSE:TEVA)
Historical Stock Chart
From Mar 2024 to Apr 2024
Teva Pharmaceutical Indu... (NYSE:TEVA)
Historical Stock Chart
From Apr 2023 to Apr 2024