Teva Announces the Launch of a Generic Version of ALOXI® in the United States
March 23 2018 - 1:27PM
Business Wire
Teva Pharmaceutical Industries Ltd., (NYSE: TEVA) today
announced the launch of a generic version of ALOXI®1 (palonosetron
HCI) injection, 0.25 mg/5 mL, in the United States.
Palonosetron hydrochloride injection—in a class of medications
called 5-HT3 receptor antagonists—is used in adults to prevent
nausea and vomiting that may occur as a result of receiving cancer
chemotherapy with a moderate or high risk of causing nausea and
vomiting. It is also given to prevent nausea and vomiting up to 24
hours after surgery.
“The shared-exclusive launch of palonosetron HCI injection marks
the eleventh injectable launch over the past year for our generics
business,” said Brendan O’Grady, Executive Vice President and head
of North America Commercial at Teva. “More importantly, we can now
provide an affordable treatment option for cancer patients faced
with challenging post-chemotherapy side effects.”
Teva has been committed to strengthening the generic injectable
business globally with continued investment in newer, higher-value
generic injectable products. With nearly 600 generic medicines
available, Teva has the largest portfolio of FDA-approved generic
products on the market and holds the leading position in
first-to-file opportunities, with over 100 pending first-to-files
in the U.S. Currently, one in seven generic prescriptions dispensed
in the U.S. is filled with a Teva generic product.
ALOXI® (palonosetron HCI) injection had annual sales of
approximately $459 million in the United States, according to IMS
data as of November 2017.
About Palonosetron Hydrochloride Injection
Palonosetron hydrochloride injection is indicated in adults
for:
- Moderately emetogenic cancer
chemotherapy -- prevention of acute and delayed nausea and vomiting
associated with initial and repeat courses.
- Highly emetogenic cancer chemotherapy
-- prevention of acute nausea and vomiting associated with initial
and repeat courses.
- Prevention of postoperative nausea and
vomiting (PONV) for up to 24 hours following surgery. Efficacy
beyond 24 hours has not been demonstrated.
As with other antiemetics, routine prophylaxis is not
recommended in patients in whom there is little expectation that
nausea and/or vomiting will occur postoperatively. In patients
where nausea and vomiting must be avoided during the postoperative
period, palonosetron hydrochloride injection is recommended even
where the incidence of postoperative nausea and/or vomiting is
low.
Important Safety Information
Palonosetron hydrochloride injection is contraindicated in
patients known to have hypersensitivity to the drug or any of its
components. Hypersensitivity reactions, including anaphylaxis, have
been reported with or without known hypersensitivity to other 5-HT3
receptor antagonists. Serotonin syndrome has been reported with
5-HT3 receptor antagonists. Most reports have been associated with
concomitant use of serotonergic drugs. Some of the reported cases
were fatal. Serotonin syndrome occurring with overdose of another
5-HT3 receptor antagonist alone has also been reported. The
majority of reports of serotonin syndrome related to 5-HT3 receptor
antagonist use occurred in a post-anesthesia care unit or an
infusion center.
In clinical trials, the most common adverse reactions in
chemotherapy-induced nausea and vomiting in adults (incidence ≥ 5%)
were headache and constipation. The most common adverse reactions
in postoperative nausea and vomiting (incidence ≥ 2%) were QT
prolongation, bradycardia, headache, and constipation.
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 2017 were $22.4 billion. For
more information, visit 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 the launch and potential benefits of Teva's generic
version of ALOXI®, 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:
- commercial success of Teva's generic
version of palonosetron HCI injection, including due to a potential
launch of an Authorized Generic version;
- our generics medicines business,
including: that we are substantially more dependent on this
business, with its significant attendant risks, following our
acquisition of Allergan plc’s worldwide generic pharmaceuticals
business (“Actavis Generics”); our ability to realize the
anticipated benefits of the acquisition (and any delay in realizing
those benefits) or difficulties in integrating Actavis Generics;
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
generic products, both from competing products and as a result of
increased governmental pricing pressures; and our ability to take
advantage of high-value biosimilar opportunities;
- our business and operations in general,
including: uncertainties relating to the potential benefits and
success of our new organizational structure and recent senior
management changes; the potential success and our ability to
effectively execute a restructuring plan; our ability to develop
and commercialize additional pharmaceutical products; 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; the restructuring of our
manufacturing network, including potential related labor unrest;
the impact of continuing consolidation of our distributors and
customers; variations in patent laws that may adversely affect our
ability to manufacture our products; adverse effects of political
or economic instability, major hostilities or terrorism on our
significant worldwide operations; and our ability to successfully
bid for suitable acquisition targets or licensing opportunities, or
to consummate and integrate acquisitions; and
- 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; potential additional adverse
consequences following our resolution with the U.S. government of
our FCPA investigation; governmental investigations into sales and
marketing practices; potential liability for sales of generic
products prior to a final resolution of outstanding patent
litigation; 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.
and other factors discussed in our Annual Report on Form 20-F
for the year ended December 31, 2016 (“Annual Report”)
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 contained herein, whether as a result of new
information, future events or otherwise. You are cautioned not to
rely on these forward-looking statements. You are advised to
consult any additional disclosures we make in our reports to
the SEC on Form 6-K, as well as the cautionary discussion of
risks and uncertainties under “Risk Factors” in our Annual Report.
These are factors that we believe could cause our actual results to
differ materially from expected results. Other factors besides
those listed could also materially and adversely affect us. This
discussion is provided as permitted by the Private Securities
Litigation Reform Act of 1995.
1 ALOXI® is a registered trademark of Helsinn Healthcare
SA, Switzerland, used under license.
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Teva Pharmaceutical Industries Ltd.IR ContactsUnited
StatesKevin C. Mannix, 215-591-8912Ran Meir,
215-591-3033orIsraelTomer Amitai, 972 (3) 926 7656orPR
ContactsUnited StatesElizabeth DeLuca,
267-468-4329Kaelan Hollon, 202-412-7076orIsraelYonatan
Beker, 972 (54) 888 5898
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