Centers for Medicare and Medicaid Services (CMS) Advises Plans Niaspan(R) is Now a Part D Eligible Drug; Confirms Niaspan as an
12 April 2006 - 8:51PM
Business Wire
Kos Pharmaceuticals, Inc. (Nasdaq:KOSP) announced today that the
Centers for Medicare and Medicaid Services (CMS) advised that the
dyslipidemic therapy Niaspan(R) will continue to be eligible for
coverage under the Medicare prescription drug program. The
announcement was made to all Prescription Drug Plans and Part D
Managed Care Plans (Plans). CMS issued a policy memorandum to Plans
Tuesday, April 11, 2006. The new policy allows Plans to cover, or
continue coverage of, Niaspan immediately, and enables patients
needing Niaspan therapy to contact their healthcare professionals
to discuss continued access. Previously, seniors participating in
Part D Plans with Niaspan on formulary were assured reimbursement
until May 31, 2006. "This prompt CMS review of prescription Niaspan
therapy demonstrates how Part D is an important tool to help
seniors enhance healthcare options," said Adrian Adams, President
and CEO, Kos Pharmaceuticals, Inc. "CMS staff clearly realizes the
importance of Niaspan as a unique therapy for raising good
cholesterol. Thankfully, their prompt decision assures healthcare
professionals and patients access to the one therapy that can
significantly raise HDL, and we appreciate CMS's efforts on behalf
of America's seniors," he added. About Niaspan Available since
1997, Niaspan is the only FDA-approved, once-daily extended-release
prescription formulation of niacin for treating abnormal
cholesterol levels. Niaspan is indicated as an adjunct to diet when
the response to a diet restricted in saturated fat and cholesterol
and other nonpharmacologic measures alone has been inadequate, to
reduce elevated total cholesterol, LDL-C, Apo B, and triglyceride
levels, and to increase HDL-C in patients with primary
hypercholesterolemia and mixed dyslipidemia. In patients with a
history of myocardial infarction and hypercholesterolemia, niacin
is indicated to reduce the risk of recurrent non-fatal myocardial
infarction or coronary artery disease and hypercholesterolemia.
Niacin, in combination with a bile acid binding resin, is indicated
to slow progression or promote regression of atherosclerotic
disease. Niaspan is contraindicated in patients with allergies to
any of its ingredients, active peptic ulcer disease, significant or
unexplained persistent liver dysfunction, or arterial bleeding.
Niaspan should not be substituted for equivalent doses of
immediate-release niacin. Niaspan should be prescribed with caution
in patients who consume substantial amounts of alcohol and/or have
a past history of liver disease. Liver function tests should be
performed on all patients during therapy with Niaspan. Use of
Niaspan with other lipid-altering medications called statins may
increase the risk of rhabdomyolysis, a rare condition that causes
muscles to breakdown. The most common side effect with Niaspan is
flushing of the skin. Other commonly reported side effects include
indigestion, headache, pain, abdominal pain, nausea, itching,
diarrhea, running nose, vomiting and rash. Patients with diabetes
should carefully monitor their blood sugar and report changes to
their doctor. About Kos Pharmaceuticals Kos Pharmaceuticals, Inc.
is a fully integrated specialty pharmaceutical company engaged in
developing, commercializing, manufacturing and marketing
proprietary prescription products for the treatment of chronic
diseases with a particular focus on the cardiovascular, metabolic
and respiratory disease areas. The Company's principal product
development strategy is to reformulate existing pharmaceutical
products with large market potential to improve safety, efficacy,
and patient compliance. Kos' strategy also includes making measured
investments in new chemical entity research through in-house and
sponsored research, scientific in-licensing and general corporate
development activities. The Company currently markets Niaspan and
Advicor(R) for the treatment of cholesterol disorders, Azmacort(R)
for the treatment of asthma, Cardizem(R)LA for the treatment of
hypertension and angina, and Teveten(R) and Teveten(R)HCT for the
treatment of hypertension. Kos has a strong and growing research
and development pipeline including proprietary drug delivery
technologies in solid-dose, inhalation and aerosol metered-dose
device administration to help fuel sustained, organic sales growth
into the future. Certain statements in this press release,
including statements relating to Niaspan, the Company's strong and
growing research and development pipeline and future sales growth
are forward-looking and are subject to risks and uncertainties
which may cause actual results to differ materially from those
projected in a forward-looking statement. These risks and
uncertainties include, the Company's ability to attract and retain
sales professionals and increase the size of its sales force, the
Company's ability to successfully develop (both internally and
through sponsored research arrangements with third parties) and
commercialize new products under development and within expected
timeframes, the Company's ability to successfully negotiate
additional important strategic business development and corporate
opportunities, the progress of the Company's research and
development pipeline, the protection afforded by the Company's
patents and those related to the acquired and licensed products,
the effect of conditions in the pharmaceutical industry and the
economy in general, the Company's ability to maintain compliance
with FDA standards without adversely affecting its manufacturing
capability or ability to meet its production requirements, the
Company's ability to ensure compliance with prescription drug sales
and marketing laws and regulations, and changes in the regulatory
environment governing the Company's compliance with FDA. A more
detailed discussion of risks attendant to the forward-looking
statements included in this press release are set forth in the
"Forward-Looking Information: Certain Cautionary Statements"
section of the Company's Annual Report on Form 10-K for the year
ended December 31, 2005, filed with the Securities and Exchange
Commission, and in other reports filed with the SEC. All
information in this press release is as of April 12, 2006 and the
Company undertakes no duty to update this information.
Kos (NASDAQ:KOSP)
Historical Stock Chart
Von Mai 2024 bis Jun 2024
Kos (NASDAQ:KOSP)
Historical Stock Chart
Von Jun 2023 bis Jun 2024