JERUSALEM--(BUSINESS WIRE)--Mar. 23, 2018--
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20180323005590/en/
Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
IR Contacts
United
States
Kevin C. Mannix, 215-591-8912
Ran Meir, 215-591-3033
or
Israel
Tomer
Amitai, 972 (3) 926 7656
or
PR Contacts
United
States
Elizabeth DeLuca, 267-468-4329
Kaelan Hollon,
202-412-7076
or
Israel
Yonatan Beker, 972 (54) 888
5898