Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) today announced
that it has entered into a definitive agreement under which Teva
will acquire NuPathe Inc. (Nasdaq:PATH) for $3.65 per share in
cash, or approximately $144 million. In addition to the upfront
cash payment, NuPathe shareholders will receive rights to receive
additional cash payments of up to $3.15 per share if specified net
sales of NuPathe’s migraine treatment, ZECUITY®, are achieved over
time.
ZECUITY is the first and only prescription migraine patch
approved by the FDA for the acute treatment of migraine with or
without aura in adults. ZECUITY is a disposable, single-use,
iontophoretic transdermal patch that actively delivers sumatriptan,
the most widely prescribed migraine medication, through the skin.
ZECUITY provides relief of both migraine headache pain and
migraine-related nausea . ZECUITY was approved based upon an
extensive development program with phase 3 trials that included 793
patients using nearly 10,000 ZECUITY patches. In these trials,
ZECUITY demonstrated a favorable safety profile and was effective
at relieving migraine headache pain and migraine-related nausea two
hours after patch activation.
With the addition of NuPathe’s ZECUITY, Teva is expanding its
portfolio of medicines that treat conditions affecting the central
nervous system (CNS). Teva will now have access to NuPathe’s
proprietary technology including its transdermal delivery system
for patients.
“We believe that ZECUITY is a great fit within our existing U.S.
CNS Business Unit, with near-term sales and significant commercial
potential" stated Mike Derkacz, Vice President and General Manager,
Teva CNS. “ZECUITY enables rapid transdermal delivery of
sumatriptan and bypasses the GI tract to avoid issues with oral
intake, addressing an important, unmet patient need, especially for
those with migraine-related nausea. At Teva, we will leverage our
unique Shared Solutions infrastructure to support patient
utilization of this important new medicine for migraine
sufferers.”
Under the terms of the agreement, an affiliate of Teva will
promptly commence a tender offer to acquire all outstanding shares
of NuPathe’s common stock for $3.65 per share in cash and the right
to receive contingent cash consideration payments of up to $3.15
per share if specified net sales thresholds for NuPathe’s ZECUITY
are achieved. The contingent cash consideration payments, which
will not be publicly traded, are as follows:
- $2.15 per share in cash payable upon
net sales of ZECUITY of at least $100 million in any four
consecutive calendar quarters, on or prior to the ninth anniversary
of the date of the first commercial sale of ZECUITY; and
- $1.00 per share in cash payable upon
net sales of ZECUITY of at least $300 million in any four
consecutive calendar quarters, on or prior to the ninth anniversary
of the date of the first commercial sale of ZECUITY.
The affiliate of Teva that consummates the tender offer will
enter into a separate Contingent Cash Consideration Agreement with
American Stock Transfer & Trust Company. The stockholders of
NuPathe will be third party beneficiaries under this agreement.
Pursuant to the terms of the Contingent Cash Consideration
Agreement, Teva will guarantee the obligations of its affiliate to
make the payments.
Following the successful completion of the tender offer, Teva
will acquire all remaining shares not tendered in the tender offer
through a second-step merger at the same price and with the
obligation to make the same contingent cash consideration payments
as to stockholders tendering their shares in the tender offer. The
tender offer and withdrawal rights are expected to expire at 12:00
midnight, New York City time on the 20th business day after the
launch of the tender offer, unless extended in accordance with the
merger agreement and the applicable rules and regulations of the
Securities and Exchange Commission.
The consummation of the tender offer is subject to various
conditions, including a minimum tender of a majority of outstanding
NuPathe shares on a fully diluted basis, the expiration or
termination of any applicable waiting periods under applicable
competition laws, and other customary conditions. The board of
directors of NuPathe unanimously approved the transaction.
The transaction is expected to be completed in February
2014.
About ZECUITY
ZECUITY is indicated for the acute treatment of migraine
with or without aura in adults. ZECUITY is a single-use,
iontophoretic patch applied to the upper arm or thigh during a
migraine. Following application and with a press of a button,
ZECUITY initiates transdermal delivery (through the skin),
bypassing the gastrointestinal tract. Throughout the four-hour
dosing period, the microprocessor within ZECUITY continuously
monitors skin resistance and adjusts drug delivery accordingly to
ensure delivery of 6.5 mg of sumatriptan, the most widely
prescribed migraine medication, with minimal patient-to-patient
variability. ZECUITY is a registered trademark of NuPathe Inc.
Important Safety Information
Patients should not take ZECUITY if they have heart disease, a
history of heart disease or stroke, peripheral vascular disease
(narrowing of blood vessels to your legs, arms, stomach or kidney),
transient ischemic attack (TIA) or problems with blood circulation,
uncontrolled blood pressure, migraines that cause temporary
paralysis on one side of the body or basilar migraine,
Wolff-Parkinson-White syndrome or other disturbances of heart
rhythm. Very rarely, certain people, even some without heart
disease, have had serious heart-related problems after taking
triptans like ZECUITY.
Patients should not use ZECUITY if they have taken other
migraine medications such as ergotamine medications or other
triptans in the last 24 hours or if they have taken monoamine
oxidase-A (MAO-A) inhibitors within the last 2 weeks.
Patients should not use ZECUITY during magnetic resonance
imaging (MRI).
Patients should not use ZECUITY if they have an allergy to
sumatriptan or components of ZECUITY or if they have had allergic
contact dermatitis (ACD) following use of ZECUITY. If patients
develop ACD, they should talk to their healthcare provider before
using sumatriptan in another form.
ZECUITY, like other triptans, may be associated with a
potentially life-threatening condition called serotonin syndrome,
mainly when used together with certain types of antidepressants
including serotonin reuptake inhibitors (SSRIs) or serotonin
norepinephrine reuptake inhibitors (SNRIs).
Patients should tell their healthcare provider before using
ZECUITY if they have heart disease or a family history of heart
disease, stroke, high cholesterol or diabetes; have gone through
menopause; are a smoker; have had epilepsy or seizures or if they
are pregnant, nursing or thinking about becoming pregnant.
The most common side effects of ZECUITY are application site
pain, tingling, itching, warmth and discomfort. Most patients
experience some skin redness after removing ZECUITY. This redness
typically goes away in 24 hours.
Go to www.zecuity.com for Full Prescribing Information, Patient
Information and Instructions for Use.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) is a leading
global pharmaceutical company, committed to increasing access to
high-quality healthcare by developing, producing and marketing
affordable generic drugs as well as innovative and specialty
pharmaceuticals and active pharmaceutical ingredients.
Headquartered in Israel, Teva is the world's leading generic drug
maker, with a global product portfolio of more than 1,000 molecules
and a direct presence in about 60 countries. Teva's branded
businesses focus on CNS, oncology, pain, respiratory and women's
health therapeutic areas as well as biologics. Teva currently
employs approximately 46,000 people around the world and reached
$20.3 billion in net revenues in 2012.
Teva's Safe Harbor Statement under the U. S. Private
Securities Litigation Reform Act of 1995: The following
presentation contains forward-looking statements, which express the
current beliefs and expectations of management. Such statements
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 innovative
medicines, especially Copaxone® (including competition from
innovative orally-administered alternatives, as well as from
potential purported generic equivalents), competition for our
generic products (including from other pharmaceutical companies and
as a result of increased governmental pricing pressures),
competition for our specialty pharmaceutical businesses, our
ability to achieve expected results through our specialty,
including innovative, R&D efforts, the effectiveness of our
patents and other protections for innovative products, decreasing
opportunities to obtain U.S. market exclusivity for significant new
generic products, our ability to identify, consummate and
successfully integrate acquisitions and license products, our
ability to reduce operating expenses to the extent and during the
timeframe intended by our cost restructuring program, uncertainties
relating to the replacement of and transition to a new President
& Chief Executive Officer, the effects of increased leverage as
a result of recent acquisitions, the extent to which any
manufacturing or quality control problems damage our reputation for
high quality production and require costly remediation, our
potential exposure to product liability claims to the extent not
covered by insurance, increased government scrutiny in both the
U.S. and Europe of our settlement agreements with brand companies
and liabilities arising from class action litigation and other
third-party claims relating to such agreements, potential liability
for sales of generic medicines prior to a final resolution of
outstanding patent litigation, our exposure to currency
fluctuations and restrictions as well as credit risks, the effects
of reforms in healthcare regulation and pharmaceutical pricing and
reimbursement, any failures to comply with complex Medicare and
Medicaid reporting and payment obligations, governmental
investigations into sales and marketing practices ,particularly for
our specialty medicines (and our ongoing FCPA investigations and
related matters), uncertainties surrounding the legislative and
regulatory pathways for the registration and approval of
biotechnology-based medicines, adverse effects of political or
economic instability, corruption, major hostilities or acts of
terrorism on our significant worldwide operations, interruptions in
our supply chain or problems with our information technology
systems that adversely affect our complex manufacturing processes,
any failure to retain key personnel or to attract additional
executive and managerial talent, the impact of continuing
consolidation of our distributors and customers, variations in
patent laws that may adversely affect our ability to manufacture
our products in the most efficient manner, potentially significant
impairments of intangible assets and goodwill, potential increases
in tax liabilities resulting from challenges to our intercompany
arrangements, the termination or expiration of governmental
programs or tax benefits, environmental risks, and other factors
that are discussed in our Annual Report on Form 20-F for the year
ended December 31, 2012 and in our other filings with the U.S.
Securities and Exchange Commission. Forward-looking statements
speak only as of the date on which they are made and the Company
undertakes no obligation to update or revise any forward looking
statement, whether as a result of new information, future events or
otherwise.
About the Tender Offer
THE TENDER OFFER DESCRIBED IN THIS DOCUMENT HAS NOT YET
COMMENCED. THIS ANNOUNCEMENT IS NEITHER AN OFFER TO PURCHASE NOR A
SOLICITATION OF AN OFFER TO SELL SHARES OF NUPATHE .
At the time the offer is commenced, an affiliate of Teva will
file a Tender Offer Statement on Schedule TO with the U.S.
Securities and Exchange Commission, and NuPathe will file a
Solicitation/Recommendation Statement on Schedule 14D-9 with
respect to the tender offer.
The Offer to Purchase, the related Letter of Transmittal and
certain other offer documents, as well as the
Solicitation/Recommendation Statement, will be made available to
all stockholders of NuPathe at no expense to them. The Tender Offer
Statement and the Solicitation/Recommendation Statement will be
made available for free at the Commission's web site at
www.sec.gov. Free copies of these materials and certain other
offering documents will be made available by the information agent
for the offer.
NUPATHE STOCKHOLDERS AND OTHER INVESTORS
ARE URGED TO READ THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO
PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER OFFER
DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT. SUCH
DOCUMENTS WILL CONTAIN IMPORTANT INFORMATION WHICH SHOULD BE READ
CAREFULLY BEFORE ANY DECISION IS MADE WITH RESPECT TO THE TENDER
OFFER
Additional Information and Where to Find It
In addition to the Solicitation/Recommendation Statement,
NuPathe files annual, quarterly and special reports, proxy
statements and other information with the Securities and Exchange
Commission. You may read and copy any reports, statements or other
information filed by NuPathe at the SEC public reference room at
100 F Street, N.E., Washington, D.C. 20549.
Please call the Commission at 1-800-SEC-0330 for further
information on the public reference room. NuPathe's filings with
the Commission are also available to the public from commercial
document-retrieval services and at the website maintained by the
Commission at www.sec.gov.
Teva Pharmaceutical Industries Ltd.IR:Kevin C.
MannixUnited States215-591-8912orRan MeirUnited
States215-591-3033orTomer AmitaiIsrael972 (3)
926-7656orPR:Iris Beck CodnerIsrael972 (3)
926-7246orDenise BradleyUnited States215-591-8974Nancy
LeoneUnited States610-727-6314
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