JERUSALEM & EWING, N.J.--(BUSINESS WIRE)--Jun. 27, 2016--
Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) and Antares
Pharma, Inc. (NASDAQ:ATRS) today announced the launch of the generic
equivalent to Imitrex®1 (sumatriptan succinate) injection, 4
mg and 6 mg single-dose, prefilled syringe autoinjectors, in the U.S.
Sumatriptan injection is used to treat acute migraine with or without
aura, and acute cluster headaches in adults. Sumatriptan injection is
self-administered subcutaneously into the back of arm or outer thigh.
Approximately 36 million people in the U.S. suffer from migraine and its
various characteristics. According to the American Migraine Study II, 85
percent of respondents experience throbbing pain, 80 percent experience
sensitivity to light, 76 percent experience sensitivity to sound and 73
percent experience nausea.
"We are pleased to add sumatriptan injection to our growing portfolio
through our successful partnership with Antares,” stated Siggi Olafsson,
President and CEO, Global Generic Medicines, Teva. “This achievement
demonstrates our ability to leverage our leadership in the
pharmaceutical industry, and our ongoing commitment to our patients,
customers and the communities that we serve.”
Teva remains committed to strengthening its presence in the treatment of
migraine and its generic injectable business globally. Teva continues
investment in new, and higher-value generic injectable products. With
approximately 370 generic medicines available, Teva has the largest
portfolio of FDA-approved generic products and continues to bring new
products to market for the patients who need them.
“We are delighted to offer this product to patients in the United States
through our partner, Teva,” said Robert F. Apple, President and CEO,
Antares Pharma. “With the approval and launch of sumatriptan injection,
we remain optimistic on progress of our other combination product
development programs with Teva, which are currently under FDA review.”
Sumatriptan injection had annual sales of approximately $183 million in
the United States, according to IMS data as of March 2016.
About Sumatriptan Injection
Sumatriptan injection is indicated in adults for the acute treatment of
migraine, with or without aura, and the acute treatment of cluster
headache. Use only if a clear diagnosis of migraine or cluster headache
has been established. If a patient has no response to the first migraine
or cluster headache attack treated with sumatriptan injection,
reconsider the diagnosis before sumatriptan injection is administered to
treat any subsequent attacks. Sumatriptan injection is not indicated for
the prevention of migraine or cluster headache attacks.
Important Safety Information
Sumatriptan injection is contraindicated in patients with: ischemic
coronary artery disease or coronary artery vasospasm, including
Prinzmetal’s angina; Wolff-Parkinson-White syndrome or other cardiac
accessory conduction pathway disorders; history of stroke or transient
ischemic attack (TIA) or history of hemiplegic or basilar migraine;
peripheral vascular disease; ischemic bowel disease; uncontrolled
hypertension; recent use (i.e., within 24 hours) of
ergotamine-containing medication, ergot-type medication, or another 5-HT1
agonist; concurrent administration of a MAO-A inhibitor or recent
(within 2 weeks) use of an MAO-A inhibitor; hypersensitivity to
sumatriptan; or severe hepatic impairment.
Serious adverse reactions associated with the use of sumatriptan or 5-HT1
agonists include: myocardial ischemia/infarction, Prinzmetal’s angina;
arrhythmias; chest, throat, neck and/or jaw pain/tightness/pressure;
cerebral hemorrhage, subarachnoid hemorrhage, and stroke; peripheral
vascular ischemia, gastrointestinal vascular ischemia/infarction,
splenic infarction, and Raynaud’s syndrome; medication overuse headache;
serotonin syndrome; significant elevation in blood pressure;
anaphylactic/anaphylactoid reactions; and seizures.
In clinical trials, the most commonly reported adverse reactions (≥5%
and > placebo) for sumatriptan injection were injection site reactions,
tingling, dizziness/vertigo, warm/hot sensation, burning sensation,
feeling of heaviness, pressure sensation, flushing, feeling of
tightness, and numbness.
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 1,000
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.
About Antares Pharma
Antares Pharma focuses on self-administered parenteral pharmaceutical
products. The Company’s product, OTREXUP™ (methotrexate) injection for
subcutaneous use, is approved in the U.S. for the treatment of adults
with severe active rheumatoid arthritis, children with active
polyarticular juvenile idiopathic arthritis and adults with severe
recalcitrant psoriasis. Antares Pharma is also developing QuickShot®
Testosterone for testosterone replacement therapy, and has recently
received a therapeutically equivalent approval from the U.S. Food and
Drug Administration for VIBEX® Sumatriptan USP for the acute treatment
of migraine and cluster headache. The Company's technology platforms
include VIBEX® disposable auto injectors, disposable multi-use pen
injectors and reusable needle-free injectors. Antares Pharma has a
multi-product deal with Teva Pharmaceutical Industries, Ltd. that
includes VIBEX® epinephrine, exenatide multi-dose pen, and teriparatide
multi-dose pen. Our reusable needle-free injector for use with human
growth hormone (hGH) is sold worldwide by Ferring B.V. The Company is
also working with AMAG Pharmaceuticals on a subcutaneous method of
administering Makena, a progesterone product indicated for use in
lowering the risk of pre-term birth. For more information, visit www.antarespharma.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 consummate the acquisition of Allergan plc’s
worldwide generic pharmaceuticals business (“Actavis Generics”) and to
realize the anticipated benefits of such acquisition (and the timing of
realizing such benefits); the fact that following the consummation of
the Actavis Generics acquisition, we will be 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 we will incur to finance the Actavis Generics acquisition; the fact
that for a period of time following the consummation of 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.
ANTARES PHARMASAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES
LITIGATION REFORM ACT OF 1995
This press release contains forward-looking statements within the
meaning of the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. Forward-looking statements are subject to
certain risks and uncertainties that can cause actual results to differ
materially from those described. Factors that may cause such differences
include, but are not limited to: market acceptance and the amount of
revenue from VIBEX® Sumatriptan Injection USP in the United States; the
timing and results of the phase 3 studies for QuickShot® Testosterone
(QS T) and acceptance of the data by the U.S. Food and Drug
Administration (“FDA”); the timing and Company’s ability to successfully
complete a New Drug Application (“NDA”) for QS T, acceptance of the NDA
for QS T by the FDA and approval of the same by the FDA; Pharmaceutical
Industries, Ltd.’s (Teva) ability to adequately and timely respond to
the Complete Response Letter received from the FDA for the VIBEX®
epinephrine pen Abbreviated New Drug Application (“ANDA”) and approval
by the FDA of the same, the timing and therapeutic equivalence rating
thereof, and any future purchase orders and revenue pre or post FDA
approval;; the outcome of the pending patent litigation between Teva and
Eli Lilly and Company regarding the Teriparatide multi-dose pen; the
timing and approval, if any, by the FDA of Teva’s ANDA for the
Teriparatide multi-dose pen and any future revenue resulting therefrom;
the outcome of the pending patent litigation between Teva and
AstraZeneca regarding the Exenatide multi-dose pen; FDA action with
respect to Teva’s ANDA filed for the Exenatide pen and future revenue
from the same; continued growth of prescriptions and sales of OTREXUP™;
the timing and results of the development project with AMAG
Pharmaceuticals for an auto injector for Makena; the timing and results
of research projects, clinical trials, and product candidates in
development; actions by the FDA or other regulatory agencies with the
respect to the Company’s products or product candidates of its partners;
continued growth in product, development, licensing and royalty revenue;
the Company’s ability to obtain financial and other resources for its
research, development, clinical, and commercial activities and other
statements regarding matters that are not historical facts, and involve
predictions. These statements involve known and unknown risks,
uncertainties and other factors that may cause actual results,
performance, achievements or prospects to be materially different from
any future results, performance, achievements or prospects expressed in
or implied by such forward-looking statements. In some cases you can
identify forward-looking statements by terminology such as ''may'',
''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'',
''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'',
''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the
negative of these terms or similar expressions, although not all
forward-looking statements contain these identifying words. Additional
information concerning these and other factors that may cause actual
results to differ materially from those anticipated in the
forward-looking statements is contained in the "Risk Factors" section of
the Company's Annual Report on Form 10-K for the year ended December 31,
2015, and in the Company's other periodic reports and filings with the
Securities and Exchange Commission. The Company cautions investors not
to place undue reliance on the forward-looking statements contained in
this press release. All forward-looking statements are based on
information currently available to the Company on the date hereof, and
the Company undertakes no obligation to revise or update these
forward-looking statements to reflect events or circumstances after the
date of this press release, except as required by law.
1 Initrex® is a registered trademark of GSK group of
companies.
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Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
IR:
United States
Kevin
C. Mannix, 215-591-8912
or
United States
Ran Meir, 215-591-3033
or
Israel
Tomer
Amitai, 972 (3) 926-7656
or
PR:
Israel
Iris
Beck Codner, 972 (3) 926-7687
or
United States
Denise
Bradley, 215-591-8974
or
Antares:
Jack Howarth, 609-359-3016
jhowarth@antarespharma.com