Posted Tuesday, October 12, 2010
East Hanover, NJ, October 7 2010 – Novartis Pharmaceuticals Corporation (http://www.us.novartis.com) today
announced the availability of patient support programs for Gilenya™ (fingolimod) 0.5 mg daily, a first-line oral treatment for relapsing forms of multiple sclerosis. Gilenya was approved by the US Food and Drug Administration (FDA) on September 21, 2010.
For people with MS and healthcare professionals seeking information about Gilenya,
Novartis offers free programs to learn about educational resources, the availability of
free starter product, and the details of our prescription and medical co-pay support
program for eligible patients. People can visit www.Gilenya.com or call 877-408-4974 for
• The Gilenya Support Program, which offers treatment information, educational
resources, assistance scheduling medical assessments and prescription benefits
• The option of free starter product once a prescription has been written to help
ensure immediate access to treatment during the benefits investigation process.
Free samples are also being provided to physician’s offices and are available
through the Gilenya Support Program.
• The Gilenya Prescription Co-Pay Support Program, which will cover a significant
portion of prescription out-of-pocket costs for eligible patients with commercial
• The Gilenya Medical Co-Pay Support Program, which will reduce the out-ofpocket
costs associated with Gilenya initiation for eligible patients who require
certain tests before starting treatment.**
• The Novartis Patient Assistance Program (PAP), which provides access to
Gilenya at no cost for eligible patients who have no third-party coverage. This
program is open to all US residents without pharmacy coverage whose income is
less than 500% of the Federal Poverty Level. In 2009, the Novartis PAP provided
free product valued at over $232 million to over 105,000 patients.
“We are deeply committed to helping provide comprehensive support services to people
with MS,” said Andy Wyss, Head of Pharma North America and President, Novartis
Pharmaceuticals Corporation. “As part of this commitment, Novartis is providing the MS
community with education and resources to help them make informed treatment
decisions and to help ensure access to Gilenya when it is deemed an appropriate
Other Novartis educational activities range from office-based education to a national
satellite broadcast for healthcare professionals taking place in more than 75 cities
nationwide. To help foster responsible communications between healthcare providers
and people with MS, Novartis will commence these healthcare provider educational
Gilenya is a prescription medicine used to treat relapsing forms of MS in adults. Gilenya
can decrease the number of MS flare-ups (relapses). Gilenya does not cure MS, but it
can help slow the build up of physical problems that MS causes.
Gilenya Important Safety Information
Gilenya may cause serious side effects such as slow heart rate (bradycardia or
bradyarrhythmia), infections, macular edema, breathing and liver problems.
Gilenya can cause a patient’s heart rate to slow down, especially after the first dose. The
heart rate will usually slow down the most about six hours after a patient takes their first
dose of Gilenya. Patients might feel dizzy or tired or be aware of a slow or irregular
heartbeat if their heart rate slows down. A doctor will watch patients for the first six hours
after they take the first dose to see if they have any serious side effects. A patient’s slow
heart rate will usually return to normal within about one month after they start taking
Gilenya. Patients should call their doctor if at any time they have dizziness, tiredness or
a slow or irregular heartbeat.
Gilenya can increase a patient’s risk of serious infections. Gilenya lowers the number of
white blood cells (lymphocytes) in the blood. This will usually go back to normal within
two months of stopping treatment. A patient’s doctor may perform a blood test before
they start taking Gilenya. Patients should call their doctor right away if they have fever,
tiredness, body aches, chills, nausea or vomiting.
Macular edema can cause some of the same vision symptoms as an MS attack (optic
neuritis). Patients may not notice any symptoms with macular edema. Macular edema
usually starts in the first three to four months after taking Gilenya. A doctor should test a
patient’s vision before they start taking Gilenya and three to four months after they start
taking Gilenya, or any time they notice vision changes during treatment. Risk of macular
edema may be higher if a patient has diabetes or has had an inflammation of the eye
called uveitis. Patients should call their doctor right away if they have blurriness,
shadows or a blind spot in the center of their vision, sensitivity to light or unusually
Some patients who take Gilenya have shortness of breath. Patients should call their
doctor right away if they have trouble breathing.
Gilenya may cause liver problems. A doctor should do blood tests to check a patient’s
liver before they start taking Gilenya. Patients should call their doctor right away if they
have nausea, vomiting, stomach pain, loss of appetite, tiredness, dark urine, or their skin
or the whites of their eyes turn yellow.
Gilenya may harm an unborn baby. Women should talk to their doctor if they are
pregnant or planning to become pregnant. Women who can become pregnant should
use effective birth control while on Gilenya and for at least two months after stopping. If
3/4 a patient becomes pregnant while taking Gilenya or if they become pregnant within two
months after stopping Gilenya, they should tell their doctor right away. Women who take
Gilenya should not breastfeed, as it is not known if Gilenya passes into breast milk.
Patients should tell their doctor about all their medical conditions, including if they have
had or now have an irregular or abnormal heartbeat, a heart rate of less than 55 beats a
minute, a fever, infection or if they are unable to fight infections, eye problems, diabetes,
breathing or liver problems, or high blood pressure. Patients should especially tell their
doctor if they have had chicken pox or have recently received the vaccine for chicken
pox. A doctor may do a test for chicken pox virus and patients may need to get the
vaccine for chicken pox and wait one month before starting Gilenya.
Patients should tell their doctor about all the medicines they take, including medicines for
heart problems or high blood pressure, vaccines, other medicines to control their
immune system or treat cancer, or ketoconazole (an antifungal) by mouth.
The most common side effects with Gilenya were headache, flu, diarrhea, back pain,
abnormal liver tests and cough.
For full Prescribing Information, including the Medication Guide please visit
About Multiple Sclerosis
While there is still much to be understood about multiple sclerosis, it is thought to be an
autoimmune disease of the central nervous system that is chronic, progressive and often
disabling. It affects over 400,000 Americans and more than 2.1 million people
worldwide.. The most common forms of the disease, relapsing forms of MS, are
characterized by exacerbations or flare-ups interspersed with periods of disease
remission. Typically, MS strikes in early adulthood between the ages of 20 and 50 and
affects women twice as frequently as men.
The foregoing release contains forward-looking statements that can be identified by
terminology such as “committed,” “launching,” “will,” “commitment,” “can,” or similar
expressions, or by express or implied discussions regarding potential future revenues
from Gilenya. You should not place undue reliance on these statements. Such forwardlooking
statements reflect the current views of management regarding future events, and
involve known and unknown risks, uncertainties and other factors that may cause actual
results to be materially different from any future results, performance or achievements
expressed or implied by such statements. There can be no guarantee that Gilenya will
achieve any particular levels of revenue in the future. In particular, management’s
expectations regarding Gilenya could be affected by, among other things, unexpected
regulatory actions or delays or government regulation generally; unexpected clinical trial
results, including unexpected new clinical data and unexpected additional analysis of
existing clinical data; unexpected adverse event reports; competition in general;
government, industry and general public pricing pressures; the company’s ability to
obtain or maintain patent or other proprietary intellectual property protection; the impact
that the foregoing factors could have on the values attributed to the Novartis Group's
assets and liabilities as recorded in the Group's consolidated balance sheet, and other
risks and factors referred to in Novartis AG’s current Form 20-F on file with the US
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 anticipated, believed, estimated or expected.
Novartis is providing the information in this press release as of this date and does not
4/4 undertake any obligation to update any forward-looking statements contained in this
press release as a result of new information, future events or otherwise.
Novartis Pharmaceuticals Corporation
Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets
innovative prescription drugs used to treat a number of diseases and conditions,
including cardiovascular, dermatological, central nervous system, bone disease, cancer,
organ transplantation, psychiatry, infectious disease and respiratory. 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, which provides healthcare solutions that address the evolving
needs of patients and societies. Focused solely on healthcare, Novartis offers a
diversified portfolio to best meet these needs: innovative medicines, cost-saving generic
pharmaceuticals, preventive vaccines, diagnostic tools and consumer health products.
Novartis is the only company with leading positions in these areas. In 2009, the Group’s
continuing operations achieved net sales of USD 44.3 billion, while approximately USD
7.5 billion was invested in R&D activities throughout the Group. Headquartered in Basel,
Switzerland, Novartis Group companies employ approximately 102,000 full-timeequivalent
associates and operate in more than 140 countries around the world. For
more information, please visit http://www.novartis.com.
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Novartis Pharmaceuticals Corporation