FDA Approves Stalevo (TM) for Treatment of Parkinson's Disease New Drug Reduces Signs and Symptoms of Disease.
NVS $40.24 -0.22 -0.5%
EAST HANOVER, N.J., Jun 13, 2003 /PRNewswire via COMTEX/ -- Novartis Pharmaceuticals Corporation today announced that
the U.S. Food and Drug Administration (FDA) has approved Stalevo (carbidopa, levodopa and entacapone) tablets, the
first new drug for Parkinson's disease in over three years, for patients with idiopathic Parkinson's disease (PD) who
experience signs and symptoms of end- of-dose "wearing off." Stalevo contains levodopa, the most widely used agent for
Parkinson's disease, plus carbidopa and entacapone. While carbidopa reduces the side effects of levodopa, entacapone
extends its benefits, permitting Parkinson's disease patients to have an improved ability to perform everyday tasks and
a reduction in symptoms associated with the disease.
Within one to two years, almost 50 percent of PD patients receiving levodopa therapy begin to notice that their
levodopa lasts for shorter periods of time, known as "wearing off." In about 15 to 20 percent of patients, "wearing
off" becomes extreme and disabling. Eventually, the effect of a levodopa dose may decrease from eight hours when
patients begin levodopa therapy to only one to two hours.
"Levodopa is recognized as the cornerstone of Parkinson's disease therapy, but its long-term use is limited by its
reduced ability to fully control Parkinson's disease symptoms," said Warren Olanow, MD, professor and chairman,
Department of Neurology, Mount Sinai School of Medicine in New York City. "By blocking the enzymatic breakdown of
levodopa, Stalevo provides more levodopa to the brain for a longer period of time. Potential patient benefits include
more "on" time during which Parkinson's symptoms are well-controlled and daily activities are improved, and simpler,
more convenient dosing."
"We are proud to introduce a product like Stalevo which can enhance the daily lives of many people with Parkinson's
disease," stated Paulo Costa, president and CEO, Novartis Pharmaceuticals Corporation. "As the fourth Parkinson's drug
Novartis has introduced in the United States, Stalevo is a clear example of our company's ongoing commitment to the
Parkinson's community."
The effectiveness of levodopa administered with carbidopa and entacapone in the treatment of Parkinson's disease was
established in three 24-week multicenter, randomized, double blind placebo-controlled trials in patients with
Parkinson's disease experiencing "wearing off." In these trials, this combination increased "on" time, reduced "off"
time and improved motor function and daily activities such as patients' ability to walk and dress. The most common side
effects of Stalevo therapy are dopaminergic in nature (e.g. dyskinesia, nausea). These side effects may be manageable
with alteration in the drug dosing schedule. Other common side effects include diarrhea, hyperkinesias, urine
discoloration, hypokinesia, abdominal pain, dizziness, constipation, fatigue, pain and hallucinations. For full
prescribing information, visit www.stalevo.com.
Parkinson's disease, a chronic and progressive neurological condition, affects approximately 1.5 million Americans.
While its cause is unknown, the symptoms of Parkinson's disease are primarily the result of degeneration of
dopaminergic cells, or neurons, in the substantia nigra, a part of the brain that controls and modulates movement.
Symptoms include limbs that tremble; slowness of movement; stiffness and rigidity of limbs and gait or balance
problems. As the disease progresses, these symptoms usually increase and impact a person's ability to work and
function.
Entacapone alone is sold in the United States as Comtan (R) and like Stalevo is marketed by Novartis Pharmaceuticals
Corporation and manufactured by Orion Pharma.
This release contains certain forward-looking statements relating to Novartis Pharmaceuticals Corporation's business,
which can be identified by the use of forward-looking terminology, such as "new", "can" and "introduce" or similar
expressions, or by discussions of strategy, plans or intentions. Such forward looking statements involve known and
unknown risks, uncertainties and other factors that may cause the actual results to be materially different from any
future results, performance, or achievements expressed or implied by such statements. Commercialization can be affected
by, amongst other things, uncertainties relating to regulatory actions or delays or government regulation generally,
the ability to obtain or maintain patent or other proprietary intellectual property protection and competition in
general, as well as factors discussed in the Company's Form 20F filed with the Securities and Exchange Commission.
Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect,
actual results may vary materially from those described herein as anticipated, believed, estimated or expected.
Novartis Pharmaceuticals Corporation researches, develops, manufacturers and markets leading innovative prescription
drugs used to treat a number of diseases and conditions, including central nervous system disorders, organ
transplantation, cardiovascular diseases, dermatological diseases, respiratory disorders, cancer and arthritis. The
company's mission is to improve people's lives by pioneering novel healthcare solutions.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG. Novartis AG
(NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2002, the Group's businesses achieved sales of
USD 20.9 billion and a net income of USD 4.7 billion. The Group invested approximately USD 2.8 billion in R&D.
Headquartered in Basel, Switzerland, Novartis Group companies employ about 77,200 people and operate in over 140
countries around the world. For further information please consult http://www.novartis.com.
For more information and for a copy of the complete prescribing information, please contact:
Media
Kate King, Novartis Pharmaceuticals Corporation
Office: 862 778 5588, Mobile: 917 446 7400
Matthew Audette, Feinstein Kean Healthcare
Office: 413 585 8979
Investor Relations
Kamran Tavangar, Novartis Corporation
Office: 212 830 2433
SOURCE Novartis Pharmaceuticals Corporation
CONTACT: Media: Kate King of Novartis Pharmaceuticals Corporation,
Office: +1-862-778-5588, Mobile: +1-917-446-7400; or Matthew Audette of
Feinstein Kean Healthcare, +1-413-585-8979; or Investor Relations: Kamran
Tavangar of Novartis Corporation, +1-212-830-2433
URL: http://www.novartis.com
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