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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version on businesswire.com: http://www.businesswire.com/news/home/20160627005316/en/
Teva Pharmaceutical Industries Ltd.IR:United StatesKevin C.
Mannix, 215-591-8912orUnited StatesRan Meir,
215-591-3033orIsraelTomer Amitai, 972 (3)
926-7656orPR:IsraelIris Beck Codner, 972 (3)
926-7687orUnited StatesDenise Bradley,
215-591-8974orAntares:Jack Howarth,
609-359-3016jhowarth@antarespharma.com
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