-Aralez Sales Force Will Be Expanded by 85 to 110 Sales
Representatives by Launch-
-YOSPRALA U.S. Commercial Launch Planned for First Week of
October-
-Company to Host Conference Call Today at 11:00 a.m. ET-
MISSISSAUGA, Ontario,
Sept. 15, 2016 /PRNewswire/
-- Aralez Pharmaceuticals Inc. (NASDAQ: ARLZ)
(TSX: ARZ), a global specialty pharmaceutical company,
announced today that the U.S. Food and Drug Administration (FDA)
has approved once-daily YOSPRALA™, the only prescription fixed-dose
combination of aspirin, an anti-platelet agent, and omeprazole, a
proton pump inhibitor (PPI) in the U.S. YOSPRALA is indicated for
patients who require aspirin for secondary prevention of
cardiovascular (CV) and cerebrovascular events and who are at risk
of developing aspirin associated gastric ulcers. The Company is
expanding its U.S. sales force by 85 representatives in September
to a total of 110 high quality sales representatives and plans to
begin the U.S. promotional launch of YOSPRALA the first week in
October.
"Daily aspirin is a standard of care for secondary
cardiovascular event prevention, but gastrointestinal symptoms are
often cited as the reason patients stop taking this important
therapy. Discontinuation of daily aspirin therapy for secondary
prevention can pose a significant cardiovascular risk," said
Lori Mosca, M.D., M.P.H, Ph.D., a
national expert in cardiovascular disease prevention and education.
"Published research shows that patients who have or are at risk of
coronary artery disease and discontinue daily aspirin treatment
have a three-fold higher risk of a major adverse cardiac event,
including death, shortly after stopping therapy. Another study
documented that aspirin discontinuation following a
gastrointestinal bleed in patients with CV disease increases the
risk of a cardiovascular event or death almost 7-fold."
YOSPRALA is designed to support both cardio- and
gastro-protection for at-risk patients through the proprietary
Intelli-COAT™ system, which is formulated to sequentially deliver
immediate-release omeprazole (40 mg) followed by a delayed-release,
enteric-coated aspirin core in either 81 mg or 325 mg dose
strengths. The YOSPRALA immediate-release omeprazole is designed to
elevate the gastric pH into a gastroprotective zone. The
enteric-coated aspirin dissolves after the pH has been elevated to
≥ 5.5, within the gastroprotective zone, thereby reducing stomach
ulcer risk.1
"The approval of YOSPRALA marks a major achievement for Aralez
and helps address the current public health dilemma around patient
discontinuation of daily aspirin therapy, which has potentially
serious consequences," said Adrian
Adams, Chief Executive Officer of Aralez. "YOSPRALA is
designed to help at-risk patients, who need the cardio-protective
benefits of daily aspirin, stay on their important treatment while
reducing the risk of developing gastric ulcers. We believe YOSPRALA
represents an important new therapeutic option for this group of
patients and healthcare providers who strive to improve patient
adherence to daily aspirin therapy. Access to preventive care is
critical and as such we will implement a responsible pricing
strategy that is designed to remove access barriers to YOSPRALA by
instituting an affordable patient copay of less than a dollar per
day for most patients. The approval of YOSPRALA together with the
recent acquisition of ZONTIVITY®, a revenue
generating oral anti-platelet product that represents an excellent
strategic fit with YOSPRALA, underscores the continued execution of
our corporate growth strategy designed to build Aralez organically
and through seizing high potential opportunities through aggressive
business development and licensing."
Aspirin is the "Gold Standard" for Secondary
Prevention
Up to an estimated 26.2 million adults in the
U.S. are at risk for secondary CV events. The occurrence of
secondary CV events among people with heart disease continues to be
a significant problem in the U.S. Patients who have experienced a
heart attack have an elevated CV risk within the first six
years2 of that first event, equating to an estimated
200,000 Americans a year who go on to have a second heart
attack.3
Recent guidelines from the American College of Cardiology and
American Heart Association affirm the importance of daily aspirin
therapy. Daily aspirin therapy, however, can cause gastrointestinal
symptoms and damage, such as gastroesophageal reflux disease,
gastric ulcers and even gastrointestinal bleeding, through both
direct and indirect mechanisms.
A 2008 Expert Consensus Task Force specifically examined ways to
reduce the gastrointestinal risks of antiplatelet therapy and
nonsteroidal anti-inflammatory drugs (NSAID) use including aspirin.
The findings included data which demonstrated that gastrointestinal
risk may occur regardless of aspirin dose or formulation, meaning
low-dose, buffered and enteric-coated aspirin preparations may not
be gastrointestinal protective. The Task Force also devised an
algorithm for the prevention and treatment of aspirin and
NSAID-related gastroduodenal injury. PPI therapy is believed to
reduce the risk in all patients and was a proposed strategy for
gastroprotection.4
"In the randomized controlled trials, YOSPRALA outperformed
enteric-coated aspirin in terms of the primary endpoint, reduction
in gastric ulceration, with higher adherence in patients at higher
risk for aspirin-associated gastric ulcerations, a secondary
endpoint," said Dr. David J.
Whellan, the first author of the publication and the James
C. Wilson Professor of Medicine, Sidney Kimmel Medical College. "We
know that over one third of patients who should be taking aspirin
for secondary prevention discontinue aspirin due in part to
gastrointestinal symptoms and that this discontinuation increases
the risk of death and recurrent heart attacks."
Studies Demonstrate YOSPRALA Clinical Benefit
The FDA
approval of YOSPRALA was based on the results from two randomized,
double-blind controlled clinical trials that patients were randomly
assigned to receive either YOSPRALA 325 mg/40 mg (n=524) or 325 mg
of enteric-coated aspirin (n=525). Each study achieved its
individual primary endpoint with patients in the YOSPRALA arm
experiencing significantly fewer endoscopic gastric ulcers compared
to those taking enteric-coated aspirin (325 mg) alone. In addition,
significantly fewer patients treated with YOSPRALA discontinued
therapy because of prespecified upper gastrointestinal adverse
events compared to patients in the enteric-coated aspirin (325 mg)
arm.5 The most common adverse reactions reported in
adults (incidence ≥ 2% and greater than 325 mg EC aspirin) during
the studies were gastritis, nausea, diarrhea, gastric polyps and
non-cardiac chest pain.
Conference Call and Webcast
Aralez will host a
conference call today at 11:00 a.m. ET, to discuss the FDA
approval of YOSPRALA. The webcast can be accessed live and will be
available for replay at www.aralez.com.
Conference Call Details
Date: Thursday, September 15, 2016
Time: 11:00 a.m. ET
Dial-in (U.S.): 877-407-8037
Dial-in (International): 201-689-8037
About YOSPRALA™
YOSPRALA is a combination of
enteric-aspirin (81 mg or 325 mg), an anti-platelet agent,
surrounded by immediate-release omeprazole (40 mg), a proton pump
inhibitor, indicated for patients who require aspirin for secondary
prevention of CV and cerebrovascular events and who are at risk of
developing aspirin-associated gastric ulcers.
The aspirin component of YOSPRALA is indicated for reducing the
combined risk of death and nonfatal stroke in patients who have had
ischemic stroke or transient ischemia of the brain due to fibrin
platelet emboli; reducing the combined risk of death and nonfatal
myocardial infarction (MI) in patients with a previous MI or
unstable angina pectoris; and reducing the combined risk of MI and
sudden death in patients with chronic stable angina pectoris. It is
also indicated for use in patients who have undergone
revascularization procedures − coronary artery bypass graft or
percutaneous transluminal coronary angioplasty − when there is a
pre-existing condition for which aspirin is already indicated.
The omeprazole component of YOSPRALA is indicated for decreasing
the risk of developing aspirin associated gastric ulcers in
patients at risk for developing aspirin-associated gastric ulcers
due to age (≥ 55) or documented history of gastric ulcers.
YOSPRALA is not for use as the initial dose of aspirin therapy
during onset of acute coronary syndrome, acute MI or before
percutaneous coronary intervention. YOSPRALA was evaluated in
clinical studies for the reduction of gastric ulcers. It was not
evaluated for the reduction of GI bleeding and therefore has not
been shown to reduce the risk of gastrointestinal bleeding due to
aspirin. YOSPRALA is not interchangeable with the individual
components of aspirin and omeprazole.
Important Safety Information
You should take
YOSPRALA (aspirin and omeprazole) exactly as prescribed, at the
lowest dose possible and for the shortest time needed. Do not
stop taking YOSPRALA without talking with your doctor. Stopping
YOSPRALA suddenly could increase your risk of having a heart attack
or stroke.
Do not take YOSPRALA if you are allergic to aspirin, omeprazole,
or any of the ingredients in YOSPRALA. Do not take YOSPRALA if have
a medical condition with severe shortness of breath, chest
tightness or pain, coughing or wheezing (asthma), sneezing, runny
nose or itchy nose (rhinitis), and growths inside of your nose or
sinuses (nasal polyps). Do not take YOSPRALA if you are allergic to
any non-steroidal anti-inflammatory drug.
Do not take YOSPRALA if you are taking a medicine that contains
rilpivirine such as EDURANT®, COMPLERA®, or
ODEFSEY®.
YOSPRALA should not be used in children.
Tell your doctor if you have unexpected bleeding, if you bleed
more than usual, or if your bleeding lasts longer than is normal
for you, such as increased bruising or more frequent nose bleeds
after taking YOSPRALA.
Tell your doctor if you have stomach problems while taking or
after you stop taking YOSPRALA. Stop taking YOSPRALA and call your
doctor right away if you have any of the following signs or
symptoms: black, bloody, or tarry stools, coughing up blood or
vomit that looks like coffee grounds, or severe nausea, vomiting,
or stomach pain.
Avoid heavy alcohol use (3 or more drinks daily) during
treatment with YOSPRALA.
YOSPRALA contains aspirin and omeprazole. Before taking
YOSPRALA, tell your doctor if you take:
- aspirin, or any prescription or over-the-counter medicines
containing aspirin or other NSAIDs (non-steroidal anti-inflammatory
drugs)
- clopidogrel bisulphate (PLAVIX®). You should not
take clopidogrel bisulphate (PLAVIX®) if you take
YOSPRALA.
- ticagrelor (BRILINTA®). If your doctor prescribes
YOSPRALA for you, you should not take YOSPRALA that contains the
325/40 mg strength dose.
Kidney problems may happen at any time during treatment with
YOSPRALA. Call your doctor if you have a decrease in the amount
that you urinate, have blood in your urine, changes in urination,
swelling, skin rash or itching, or your breath smells like
ammonia.
YOSPRALA can cause diarrhea caused by an infection
(Clostridium difficile) in your intestines. Call your doctor
if you have watery stools or stomach pain that does not go away.
You may or may not have a fever.
Bone fractures (hip, wrist, or spine) in people who take
multiple daily doses of proton pump inhibitor (PPI)-containing
medicines like YOSPRALA for a long period of time (a year or
longer) may occur.
Certain types of lupus erythematosus may happen or get worse in
people who already have lupus and who take PPI medicines, including
YOSPRALA. Call your doctor right away if you have joint pain or a
rash on your cheeks or arms that gets worse in the sun.
Liver problems may happen during treatment with YOSPRALA. Tell
your doctor if you have signs or symptoms of liver problems,
including: yellowing of your skin or your eyes, stomach-area
(abdominal) pain and swelling, itchy skin, and dark (tea-colored)
urine.
Low vitamin B12 levels in your body can happen in people who
have taken a PPI medicine, such as omeprazole, for a long time
(more than 3 years). Tell your doctor if you have symptoms of low
vitamin B12 levels, including: shortness of breath,
lightheadedness, irregular heartbeat, muscle weakness, pale skin,
feeling tired, mood changes, and tingling or numbness.
Low magnesium levels in your body can happen in people who have
taken YOSPRALA for at least 3 months. Tell your doctor if you have
symptoms of low magnesium levels, including: seizures, dizziness,
irregular heartbeat, jitteriness, muscle aches or weakness, and
spasms of hands, feet or voice.
If you are pregnant, planning to become pregnant, or nursing,
talk to your doctor before taking YOSPRALA. Breastfeeding is not
recommended during treatment with YOSPRALA.
Tell your doctor about all the medicines you take, including
prescription and non-prescription drugs, anti-cancer drugs,
vitamins, and herbal supplements. YOSPRALA may affect how other
medicines work, and other medicines may affect how YOSPRALA works.
This can cause serious side effects.
Especially tell your doctor if you are taking:
- a medicine that contains rilpivirine (EDURANT®,
COMPLERA®, ODEFSEY®)
- clopidogrel bisulphate (PLAVIX®)
- ticagrelor (BRILINTA®)
- St. John's Wort (Hypericum perforatum)
- rifampin (RIMACTANE, RIFATER®, RIFAMATE®,
RIFADIN®)
- methotrexate (OTREXUP, RASUVO, TREXALL)
YOSPRALA is not interchangeable with the individual components
of aspirin and omeprazole.
The most common side effects of YOSPRALA include: indigestion or
heartburn and stomach-area pain, nausea, diarrhea, growths (polyps)
in your stomach, and chest pain behind the breastbone, for example,
with eating.
The risk information provided here is not comprehensive. To
learn more, talk about YOSPRALA with your pharmacist or other
health care providers. The product information can be found at www.
YOSPRALA.com or 1-866-207-6592.
Call your doctor for medical advice about side effects. You
are encouraged to report negative side effects of prescription
drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088.
For full prescribing information and additional important safety
information, please visit: www.YOSPRALA.com.
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 the anticipated timing of
our U.S. commercial launch of YOSPRALA, expansion of our U.S. sales
force, successful execution of our commercialization strategy
with respect to YOSPRALA, YOSPRALA as an important new therapeutic
option, the benefits of and risks of aspirin therapy and PPIs, such
as omeprazole, and the ability of YOSPRALA to address the benefits
and risks of aspirin therapy and improve patient compliance
therewith, YOSPRALA pricing and access, including affordable
patient copays of less than a dollar a day for most patients,
ZONTIVITY as a revenue generating product that represents an
excellent strategic fit with YOSPRALA, execution of our corporate
growth strategy organically and through seizing high potential
opportunities through aggressive business development and
licensing, 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 in a timely and
cost-effective manner; our failure to successfully commercialize
our product candidates; costs and delays in the development and/or
approval of our product candidates, 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;
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 Miner PB Jr, et al. Aliment Pharmacol Ther.
2013;38(1):62-71.
2 Thom T, et al. Circulation.
2006;113(6):e85-e151.
3 Mozaffarian D, et al. Circulation.
2015;133:e38-360, p. e293.
4 Bhatt D, et al. Circulation. 2008;
118(18):1894-909.
5 Whellan D, et al. Am Heart J. 2014
Oct;168(4):495-502.
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