JERUSALEM--(BUSINESS WIRE)--Jan. 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.
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.
Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
IR:
Kevin C. Mannix
United
States
215-591-8912
or
Ran Meir
United States
215-591-3033
or
Tomer
Amitai
Israel
972 (3) 926-7656
or
PR:
Iris
Beck Codner
Israel
972 (3) 926-7246
or
Denise
Bradley
United States
215-591-8974
Nancy Leone
United
States
610-727-6314