-Acquired ZONTIVITY® in the U.S. and
Canada-
-Long-range market exclusivity through regulatory exclusivity
and intellectual property protection-
MISSISSAUGA, Ontario,
Sept. 7, 2016 /CNW/ -- Aralez
Pharmaceuticals Inc. (NASDAQ: ARLZ) (TSX: ARZ), a
global specialty pharmaceutical company, today announced that it
acquired the U.S. and Canadian rights to ZONTIVITY® (vorapaxar),
pursuant to an asset purchase agreement entered into between Merck,
known as MSD outside the United
States and Canada, and
Aralez Pharmaceuticals Trading DAC, a subsidiary of Aralez, based
in Ireland. ZONTIVITY is the first
and only approved therapy shown to inhibit the protease-activated
receptor-1 (PAR-1), the primary receptor for thrombin, which is
considered to be the most potent activator of platelets. In the
U.S., ZONTIVITY is indicated for the reduction of thrombotic
cardiovascular events in patients with a history of heart attack
(myocardial infarction) or in patients with narrowing of leg
arteries, called peripheral arterial disease (PAD), and should be
used in combination with daily aspirin and/or clopidogrel according
to their indications or standard of care. In Canada, ZONTIVITY (vorapaxar sulfate)
co-administered with aspirin with or without clopidogrel, according
to their standard of care, is indicated for the reduction of
atherothrombotic events in adult high-risk patients with a history
of myocardial infarction (MI).
The asset purchase agreement included an initial upfront payment
of $25 million, which was paid from
cash on hand. The transaction also includes graduated royalties and
potential added future consideration in the form of payments for
achieving certain aggregate annual sales-based milestones. In
addition to the Asset Purchase Agreement, the parties
simultaneously entered into a Supply Agreement, a License Agreement
with respect to trademarks and certain proprietary know-how and a
Transition Services Agreement. Under the terms of the Transition
Services Agreement, Merck will continue to distribute the product
on behalf of Aralez for up to twelve months while the product
rights, packaging and labeling and other responsibilities are
transferred to Aralez Pharmaceuticals Trading DAC.
The U.S. prescribing information for ZONTIVITY includes a boxed
warning regarding bleeding risk. ZONTIVITY is not for use in
patients with a history of stroke, transient ischemic attack (TIA)
or intracranial hemorrhage (ICH), or active pathological bleeding.
Antiplatelet agents, including ZONTIVITY, increase the risk of
bleeding, including ICH and fatal bleeding.
ZONTIVITY is a once-daily tablet containing 2.08 mg of
vorapaxar, equivalent to 2.5 mg of vorapaxar sulfate. There is no
experience with use of ZONTIVITY as the only administered
antiplatelet agent, because ZONTIVITY was studied only as an
addition to aspirin and/or clopidogrel.
"ZONTIVITY represents a revenue-generating asset with NCE
regulatory data exclusivity and patent protection potentially
extending to 2027. It is an excellent strategic fit with our anchor
therapeutic position in cardiovascular disease targeting high
prescribing cardiologists alongside YOSPRALATM, pending
FDA approval, and FIBRICOR®," said Adrian
Adams, Chief Executive Officer of Aralez. "This transaction
is consistent with our business model designed to build value
organically through the approval and commercialization of YOSPRALA,
currently pending FDA approval with a September 14, 2016 PDUFA date, and through
seizing high potential growth opportunities through aggressive
business development and licensing in our anchor positions in
cardiovascular disease, pain management and other specialty
therapeutic areas."
About Heart Attack and PAD
Heart attacks are
generally caused by atherosclerotic plaque disruption and thrombus
(blood clot) formation in a coronary artery. Each year, about
750,000 Americans have a new (550,000) or recurrent (200,000) heart
attack.1
Peripheral arterial disease (PAD) is generally defined as
obstruction of arteries supplying the lower or upper extremities,
most commonly due to atherosclerosis and much more commonly
involving the lower extremities. About 8.5 million individuals in
the U.S. have PAD, of whom approximately 10 percent have classic
claudication symptoms (i.e., calf muscle pain on exertion), and
another 50 percent have other leg symptoms. People with PAD are at
increased risk for heart attack, stroke and cardiovascular death.
1
Clinical Data for ZONTIVITY
Data supporting the
benefit of ZONTIVITY are from the pivotal TRA 2°P TIMI 50 (Thrombin
Receptor Antagonist in Secondary Prevention of Atherothrombotic
Ischemic Events) trial. In patients with a history of heart attack
or with PAD who had no history of stroke or transient ischemic
attack (TIA), ZONTIVITY added to aspirin and/or clopidogrel
produced a significant 17 percent relative risk reduction over
three years for the combined events of CV death, MI, stroke, and
urgent coronary revascularization (UCR) (event rate 10.1 percent
vs. 11.8 percent for placebo). These results were driven by an 18
percent relative risk reduction in MI [5.4 percent vs. 6.4 percent
for placebo] and a 33 percent relative risk reduction in first
stroke [1.2 percent vs. 1.6 percent for placebo]. Adding ZONTIVITY
to aspirin and/or clopidogrel was associated with an increased rate
of Global Utilization of Streptokinase and Tissue Plasminogen
Activator for Occluded Arteries (GUSTO) moderate or severe bleeding
through three years (3.7%) compared to adding placebo (2.4%),
(hazard ratio 1.55, 95% CI 1.30-1.86). GUSTO severe bleeding
occurred at a rate of 1.3 percent for ZONTIVITY versus 1.0 percent
for placebo (HR: 1.24, 95 percent CI: 0.92-1.66).
Additional Selected Safety Information About
ZONTIVITY
ZONTIVITY is contraindicated in patients with a
history of stroke, TIA, or ICH and in patients with active
pathological bleeding such as ICH or peptic ulcer. Discontinue
ZONTIVITY in patients who experience a stroke, TIA, or ICH.
Antiplatelet agents, including ZONTIVITY, increase the risk of
bleeding, including ICH and fatal bleeding. ZONTIVITY increases the
risk of bleeding in proportion to the patient's underlying bleeding
risk. Physicians should consider the underlying risk of bleeding
before initiating ZONTIVITY.
General risk factors for bleeding include older age, low body
weight, reduced renal or hepatic function, and history of bleeding
disorders. Use of certain concomitant medications (e.g.,
anticoagulants, fibrinolytic therapy, chronic nonsteroidal
anti-inflammatory drugs, selective serotonin reuptake inhibitors,
selective norepinephrine reuptake inhibitors) also increases the
risk of bleeding. Avoid concomitant use of warfarin or other
anticoagulants. ZONTIVITY is not recommended in patients with
severe hepatic impairment.
Withholding ZONTIVITY for a brief period will not be useful in
managing an acute bleeding event because, due to its long
half-life, significant inhibition of platelet aggregation remains
four weeks after discontinuation. There is no known treatment to
reverse the antiplatelet effect of ZONTIVITY.
Strong CYP3A inhibitors increase and inducers decrease ZONTIVITY
exposure. Avoid concomitant use of ZONTIVITY with strong CYP3A4
inhibitors or inducers.
Bleeding, including life-threatening and fatal bleeding, is the
most commonly reported adverse reaction with ZONTIVITY.
For more information on ZONTIVITY, please refer to full
Prescribing Information including Boxed Warning and Medication
Guide.
About Aralez Pharmaceuticals Inc.
Aralez
Pharmaceuticals Inc. (NASDAQ: ARLZ and TSX: ARZ) is a global
specialty pharmaceutical company focused on delivering meaningful
products to improve patients' lives while creating shareholder
value by acquiring, developing and commercializing products
primarily in cardiovascular, pain and other specialty areas.
Aralez's Global Headquarters is in Mississauga, Ontario, Canada, its U.S.
Headquarters is planned to be in Princeton, NJ and the Irish Headquarters is in
Dublin, Ireland. More information
about Aralez can be found at www.aralez.com.
Cautionary Language Concerning Forward-Looking
Statements
This press release includes certain statements
that constitute "forward-looking statements" within the meaning of
applicable securities laws. Forward-looking statements include, but
are not limited to, statements regarding our ability to
successfully integrate the acquisition of ZONTIVITY, payments of
additional consideration on achieving milestones and graduated
royalties, the benefits of ZONTIVITY, including management's
related beliefs, our ability to successfully commercialize
ZONTIVITY, the expected benefits to Aralez of such
commercialization efforts, including ZONTIVITY as a revenue
generating asset, ZONTIVITY as an excellent strategic fit
with our anchor therapeutic position in cardiovascular disease and
long range market exclusivity through regulatory exclusivity and
patent protection potentially extending to 2027, building value
organically through the approval and commercialization of YOSPRALA,
currently pending FDA approval with a September 14, 2016 PDUFA date, our business
development and licensing efforts, and other statements that are
not historical facts, and such statements are typically identified
by use of terms such as "may," "will," "would," "should," "could,"
"expect," "plan," "intend," "anticipate," "believe," "estimate,"
"predict," "likely," "potential," "continue" or the negative or
similar words, variations of these words or other comparable words
or phrases, although some forward-looking statements are expressed
differently.
You should be aware that the forward-looking statements included
herein represent management's current judgment and expectations,
and are based on current estimates and assumptions made by
management in light of its experience and perception of historical
trends, current conditions and expected future developments, as
well as other factors that it believes are appropriate and
reasonable under the circumstances, but there can be no assurance
that such estimates and assumptions will prove to be correct and,
as a result, the forward-looking statements based on those
assumptions could prove to be incorrect. Accordingly, actual
results, level of activity, performance or achievements or future
events or developments could differ materially from those expressed
or implied in the forward-looking statements. Our operations
involve risks and uncertainties, many of which are outside of our
control, and any one or any combination of these risks and
uncertainties could also affect whether the forward-looking
statements ultimately prove to be correct and could cause our
actual results, level of activity, performance or achievements or
future events or developments to differ materially from those
expressed or implied by the forward-looking statements. These risks
and uncertainties include, without limitation, our inability to
build, acquire or contract with a sales force of sufficient scale
for the commercialization of YOSPRALA, if approved, in a timely and
cost-effective manner; our failure to successfully commercialize
our product candidates; costs and delays in the development and/or
FDA approval of our product candidates (including YOSPRALA),
including as a result of the need to conduct additional studies or
due to issues with third-party API or finished product
manufacturers, or the failure to obtain such approval of our
product candidates for all expected indications, including as a
result of changes in regulatory standards or the regulatory
environment during the development period of any of our product
candidates; the inability to maintain or enter into, and the risks
resulting from our dependence upon, collaboration or contractual
arrangements necessary for the development, manufacture,
commercialization, marketing, sales and distribution of any
products, including our dependence on AstraZeneca AB and Horizon
Pharma USA, Inc. for the sales and
marketing of VIMOVO, and our dependence on Patheon Pharmaceuticals
Inc. for the manufacture of YOSPRALA™ 81/40 and YOSPRALA™ 325/40;
our ability to protect our intellectual property and defend our
patents; regulatory obligations and oversight; failure to
successfully identify, execute , integrate and maintain new
acquisitions, such as the integration of ZONTIVITY; fluctuations in
the value of certain foreign currencies, including the Canadian
dollar, in relation to the U.S. dollar, and other world currencies;
changes in government regulations, including tax laws and
unanticipated tax liabilities; general adverse economic, market and
business conditions; and those risks detailed from time-to-time
under the caption "Risk Factors" and elsewhere in the Company's
Securities and Exchange Commission ("SEC") filings and reports and
Canadian securities law filings, including in our Annual Report on
Form 10-K for the year ended December 31,
2015 and our Quarterly Report on Form 10-Q for the quarterly
period ended June 30, 2016, which are
available on EDGAR at www.sec.gov, on SEDAR at www.sedar.com, and
on the Company's website at www.aralez.com, and those described
from time to time in our future reports filed with the SEC and
applicable securities regulatory authorities in Canada. You should not place undue importance
on forward-looking statements and should not rely upon this
information as of any other date. We undertake no obligation to
publicly update or revise any forward-looking statements, whether
as a result of new information, future events or otherwise, unless
required by law.
Contact Information:
Aralez Pharmaceuticals US Inc.
Nichol Ochsner
Executive Director,
Investor Relations & Corporate Communications
732.754.2545
nochsner@aralez.com
1 Mozaffarian D, et al. Heart Disease and Stroke
Statistics – 2016 Update. Circulation 2016
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SOURCE Aralez Pharmaceuticals Inc.