Allergan plc a leading global pharmaceutical company announced that data on nebivolol and an investigational fixed-dose combination (FDC) of nebivolol and valsartan will be presented at the American Society of Hypertension (ASH) Annual Scientific Meetingscheduled May 13-17, 2016 in New York. The U.S. Food & Drug Administration (FDA) is currently reviewing a New Drug Application for the nebivolol/valsartan FDC for the treatment of hypertension. Nebivolol is approved and marketed in the US as BYSTOLIC for the treatment of hypertension, to lower blood pressure.
The posters include data from multiple hypertension studies.
"Nearly half of all hypertension patients in the U.S. have not achieved blood pressure control," said David Nicholson, Chief R&D Officer at Allergan. "Allergan is dedicated to continuing to develop and provide treatment options to help physicians and patients across various populations achieve control."
The following four posters will be presented on:
Monday, May 16, 2016, Noon – 1:00 PM ET
- Increased Placebo Response in Hispanics Compared to Other Ethnic Groups in Hypertension Trials: An Analysis of Nebivolol Trials authored byThomas D. Giles, Henry Punzi, Madhuja Mallick, William Ferguson, Mehul Patel
- The Effects of Nebivolol-Valsartan Single-Pill Combinations in Reducing Blood Pressure in Patients With Stage I or II Hypertension authored by M. A. Weber, G. L. Bakris, W. B. White, M. Patel, D. Bharucha, L. Xie
- The Effects of Nebivolol on Weight in Individuals with Hypertensionauthored by John Flack, Madhuja Mallick, Mehul Patel
- Additivity of Nebivolol/Valsartan Single-Pill Combination Versus Other Single-Pill Combinations for Hypertension authored by J. Ishak, M. Rael, H. Punzi, A. Gradman, M. Patel, S. Ali, W. Ferguson, J. Neutel
About Hypertension
According to the U.S. Centers for Disease Control and Prevention, hypertension has been called the "silent killer" because it often has no warning signs or symptoms and has been associated with serious cardiovascular (CV) risks, such as stroke and myocardial infarction. Hypertension represents a significant public health issue with high prevalence in the United States. According to the National Institute for Health Statistics, approximately 30 percent of adults in the U.S. have hypertension. Inadequate control of hypertension is a significant public health problem, with approximately half of all patients still not achieving target goals. Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce CV morbidity and mortality, and it can be concluded that it is blood pressure reduction that is largely responsible for those benefits. There are no controlled trials demonstrating risk reduction with nebivolol and the investigational nebivolol/valsartan FDC. In addition, approximately two-thirds of hypertensive patients will require more than one drug to achieve blood pressure goals, further emphasizing the importance of antihypertensive drug combinations and of studies of safety and efficacy such as this program's.
About Nebivolol and Nebivolol/Valsartan
Nebivolol (marketed in the U.S. as BYSTOLIC®) is a cardioselective beta blocker up to and including the 10mg dose and in extensive metabolizers. While nebivolol's mechanism of action has not been definitively established, possible factors that may be involved include vasodilation, decreased peripheral vascular resistance, reduced heart rate and myocardial contractility, suppression of renin, and reduced sympathetic activity. Nebivolol is indicated for the treatment of hypertension and is effective at lowering blood pressure when taken alone or in combination with other antihypertensive agents.
Nebivolol/Valsartan FDC is an investigational combination of nebivolol and an angiotensin II receptor blocker (ARB) that blocks the binding of angiotensin II to the AT1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland, thereby preventing its vasoconstrictor and aldosterone-secreting effects. Like nebivolol, valsartan has been well studied in many different patient populations and is an effective antihypertensive agent. This combination is currently under review by theFDA for the treatment of hypertension.
About Allergan
Allergan plc headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women's health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world's third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Allergan is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.
With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.
For more information, visit Allergan's website at www.allergan.com .
CONTACTS:
Investors:
Lisa DeFrancesco
+1 (862) 261 7152
nvestor.relations@allergan.com
Media:
Mark Marmur
+1 (862) 261 7558
mark.marmur@allergan.com
