Teva Expands CNS Specialty Business with Acquisition of NuPathe
JERUSALEM -- January 21, 2014
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.
ZECUITYis 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
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
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
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.
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.
Kevin C. Mannix
972 (3) 926-7656
Iris Beck Codner
972 (3) 926-7246
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