Forest Laboratories, Inc. (NYSE:FRX) today announced that data on an investigational fixed-dose combination (FDC) of nebivolol and valsartan will be presented at the American Society of Hypertension (ASH) Annual Scientific Meeting scheduled May 16-20, 2014 in New York. Forest recently submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for the nebivolol/valsartan FDC for the treatment of hypertension.

The following four posters will be presented on Saturday, May 17 from 5:00 pm -7:30 pm EST:

  • Efficacy and Safety of Nebivolol and Valsartan in Fixed-Dose Combinations in Patients With Stage 1 or 2 Hypertension presented by Thomas Giles, M.D., Professor of Medicine, Tulane University School of Medicine
  • Plasma Renin Activity and Aldosterone Levels in Patients With Hypertension Receiving Fixed-Dose Combination of Nebivolol and Valsartan: Substudy of a Phase 3 Randomized Trial presented by Thomas Giles, M.D., Professor of Medicine, Tulane University School of Medicine
  • Fixed-Dose Combination of Nebivolol and Valsartan in Patients With Stage 1 or 2 Hypertension: ABPM Substudy of a Phase 3 Randomized Trial presented by Thomas Giles, M.D., Professor of Medicine, Tulane University School of Medicine
  • Long-Term Safety of Nebivolol and Valsartan Combination Therapy in Patients With Hypertension: An Open-Label, Single-Arm, Multicenter Study presented by Joel M. Neutel M.D., Director of Research, Orange County Research Center

About Hypertension

According to the CDC, 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. According to the National Institute for Health Statistics, approximately 30% of adults in the United States have hypertension. Inadequate control of hypertension is a significant public health problem, with nearly 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 BP reduction that is largely responsible for those benefits. Elevated blood pressure causes increased CV risk, and the absolute risk increase per mm Hg is greater at higher blood pressures, so even modest reductions of severe hypertension can provide substantial benefit. Two-thirds of hypertensive patients will require more than one drug to achieve blood pressure goals.

About Nebivolol and 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.

Valsartan is 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. Valsartan has been well studied in many different patient populations and is an effective antihypertensive agent.

About Forest Laboratories

Forest Laboratories (NYSE:FRX) is a leading, fully integrated, specialty pharmaceutical company largely focused on the United States market. Forest markets a portfolio of branded drug products and develops new medicines to treat patients suffering from diseases principally in five therapeutic areas: central nervous system, cardiovascular, gastrointestinal, respiratory, and anti-infective. Forest’s strategy of acquiring product rights for development and commercialization through licensing, collaborative partnerships and targeted mergers and acquisitions allows Forest to take advantage of attractive late-stage development and commercial opportunities, thereby managing the risks inherent in drug development. In January 2014, Forest acquired Aptalis Pharmaceuticals for $2.9 billion in cash in order to gain access to its GI and Cystic Fibrosis products, including treatments for Ulcerative Proctitis, Duodenal Ulcers, H. Pylori, Anal Fissures, and Pancreatic Insufficiency. In February 2014, Forest and Actavis plc announced an agreement where Forest would be acquired for about $25 billion in cash and stock. The acquisition of Forest by Actavis is contingent upon regulatory and shareholder approvals.

Forest is headquartered in New York, NY. To learn more, visit www.frx.com.

Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in Forest Laboratories' Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings. Forest assumes no obligation to update forward-looking statements contained in this release to reflect new information or future events or developments.