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Aralez Announces FDA Approval Of YOSPRALA For Secondary Prevention Of Cardiovascular And Cerebrovascular Events In Patients At Risk For Aspirin-Associated Gastric Ulcers
-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
"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
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
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
"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.
Studies Demonstrate YOSPRALA Clinical Benefit
Conference Call and Webcast
Aralez will host a conference call today at 11:00 a.m. ET, to discuss the
Conference Call Details
Dial-in (U.S.): 877-407-8037
Dial-in (International): 201-689-8037
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
For full prescribing information and additional important safety information, please visit: www.YOSPRALA.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
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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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