Forest Laboratories, Inc. to Present Nebivolol/Valsartan Fixed-Dose Combination Data at the American Society of Hypertension ...
May 16 2014 - 4:05PM
Business Wire
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.
Forest Laboratories, Inc.Frank J. Murdolo, 212-224-6714Vice
President - Investor Relationsmedia.relations@frx.comorAmanda
KaufmanMedia Relationsamanda.kaufman@frx.com
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