- New professional cycling team, called NOW and Novartis for MS, to compete nationally and ride tandem with MS patients in National MS Society’s bike rides
- Program kicks-off on the eve of World MS Day, inspiring communities to better understand MS and how it affects the over 400,000 Americans living with MS
- Builds on Keoghan’s longstanding commitment to MS, including his challenging coast-to-coast cycle for MS, as documented in his 2011 film, “The Ride”
East Hanover, New Jersey, May 24, 2011 - Novartis Pharmaceuticals Corporation today announced its collaboration with Phil Keoghan, host of “The Amazing Race” and founder of No Opportunity Wasted (NOW), to create NOW and Novartis for MS, an inspirational cycling team of professional female cyclists. These world class riders will be paired with a person with multiple sclerosis (MS) and participate in a 10 city tour of National MS Society’s Bike MS rides to inspire communities to achieve a deeper understanding of MS and how people are affected by the disease. The first leg of the Bike MS tour takes place Saturday, June 25, near Denver, CO. The professional cyclistsalso will compete nationally on the women’s cycling race circuit, to further support MSawareness.
"Bringing attention to MS is a personal passion and ongoing mission for me, and I am thrilled to be lending my voice to this new program in support of this cause,” said Phil Keoghan, the founder of NOW, a brand and philosophy of living life to the fullest. “This project is near and dear to our hearts; we have a relative who has been battling MS for 14 years, it’s time to all come together in the fight against it.”
As part of NOW and Novartis for MS, 10 people with MS will participate in the tour serving as inspirational examples of people who are taking control and refusing to let their disease define them. MS is an often disabling disease that is chronic and progressive. This disease typically strikes during the prime of someone’s life, between the ages of 20 and 50.
“The unpredictability of MS is one of the most difficult things to cope with, so taking control of my disease to the best of my ability is what’s empowering for me,” said Ana Molé, who was diagnosed with MS in 2001. “I’m proud to be on the frontlines of this program and showing, first hand, on behalf of the over 400,000 Americans living with the disease, that we do not have to be defined by it.”
In 2009, Keoghan embarked on a challenging 3,500-mile bike ride across America that raised over $500,000 for the National MS Society. He documented this journey through “The Ride,” a film that has been shown nationwide in 2011, and with additional fundraising efforts and proceeds from the box office, has raised $200,000 more for the organization. For information about team members, events and ways to participate, visit www.noopportunitywasted.com.
The NOW and Novartis for MS team will participate in the following National MS Society’s Bike MS rides in or around: Denver, CO (June 25); Boston, MA (July 16); Minneapolis, MN (July 24); Cleveland, OH (Aug. 13); Santa Fe, NM (Aug. 27); Memphis, TN (Sept. 10); Detroit, MI (Sept. 17); Morristown, NJ (Sept. 24); St. Augustine, FL (Oct. 1) and Ventura, CA (Oct.1). The NOW and Novartis for MS tour will conclude with the Ventura ride, where Keoghan will join the team to ride on Saturday, October 1.
"By sharing the stories of people who are living with—and beyond—their disease, NOW and Novartis together hope to inspire a deeper understanding and appreciation for the MS community that we serve and are honored to be a part of,” said André Wyss, Head of Novartis Pharma North America and President of Novartis Pharmaceuticals Corporation. “At Novartis, we are committed to meeting the needs of people with MS through patient education, innovative and effective treatment options, as well as services and support to help people manage their disease.”
In September 2010, Novartis received U.S. Food and Drug Administration approval for Gilenya ™ (fingolimod), the first oral treatment for relapsing forms of MS available in the U.S. Gilenya is an effective prescription medicine proven to decrease the number of MS flare-ups (relapses) and slow down the physical problems MS causes. In a two-year study, Gilenya reduced MS relapses by 54% (p<0.001; primary endpoint) and showed a 30% reduction in the risk of 3-month confirmed disability (p<0.05; key secondary endpoint) compared to placebo.
Gilenya is the first oral treatment in a new class of drugs called sphingosine 1-phosphate receptor (S1PR) modulators. As shown in animal models, Gilenya stops many of the white blood cells from leaving the lymph nodes. Exactly how Gilenya works in MS is unknown, but it is thought to keep the white blood cells from entering the central nervous system (CNS). Without Gilenya these white blood cells would attack and damage the myelin sheath that protects nerve fibers in the CNS. If Gilenya treatment is stopped for any reason, the number of white blood cells circulating in the body increases over the first few days and gradually returns to normal within 1 to 2 months.
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.
Gilenya Indication
Gilenya is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS) in adults. Gilenya can decrease the number of MS flare-ups (relapses). Gilenya does not cure MS, but it can help slow down the physical problems that MS causes.
Important Safety Information
Gilenya may cause serious side effects such as:
Slow heart rate, especially about 6 hours after the first dose. If a patient’s heart rate slows down, they might feel dizzy or tired, or be aware of a slow or irregular heartbeat. A doctor will watch patients for the first 6 hours after their first dose for any serious side effects. If a patient experiences slow heart rate, it will usually return to normal within 1 month. Patients should call their doctor if at any time they have dizziness, tiredness, or a slow or irregular heartbeat. If a patient stops taking Gilenya for 2 weeks or more, they will need to repeat this observation.
Increased risk of serious infections. Gilenya lowers the number of white blood cells (lymphocytes) in a patient’s blood. This will usually go back to normal within 2 months of stopping Gilenya. Doctors may do a blood test before a patient starts Gilenya. Increased risk of infection was seen with Gilenya doses greater than the recommended dose. Patients should call their doctor right away if they have fever, tiredness, body aches, chills, nausea, or vomiting.
Macular edema, a vision problem, can cause some of the same vision symptoms as an MS attack (optic neuritis), or no symptoms. Macular edema usually starts in the first 3 to 4 months after starting Gilenya. Doctors should test a patient’s vision before they start Gilenya; 3 to 4 months after they start Gilenya; and any time they notice vision changes. Vision problems may continue after macular edemahas gone away. A patient’s risk of macular edema may be higher if they have diabetes or have had an inflammation of their eye (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 colored vision.
Breathing problems. Some patients have shortness of breath. Patients should call their doctor right away if they have trouble breathing.
Liver problems. Doctors should do blood tests to check a patient’s liver before they start Gilenya. Patients should call their doctor right away if they have nausea, vomiting, stomach pain, loss of appetite, tiredness, dark urine, or if their skin or the whites of their eyes turn yellow.
Increases in blood pressure (BP). BP should be monitored during treatment.
Gilenya may harm an unborn baby. Patients 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 2 months after stopping. If a patient becomes pregnant while taking Gilenya, or within 2 months after stopping, they should tell their doctor right away. Women who take Gilenya should not breast-feed, as it is not known if Gilenya passes into breast milk. A pregnancy registry is available for women who become pregnant during Gilenya treatment. Call 1-877-598-7237 for more information.
Patients should tell their doctor about all their medical conditions, including if they had or now have an irregular or abnormal heartbeat; a heart rate less than 55 beats a minute; heart problems; a history of fainting; a fever or infection, or if they are unable to fight infections; eye problems; diabetes; breathing or liver problems; or high blood pressure. Patients should tell their doctor if they have chicken pox or have received the vaccine for chicken pox. A doctor may do a test for the chicken pox virus, and patients may need to get the vaccine for chicken pox and wait 1 month before starting Gilenya.
Patients should tell their doctor about all the medicines they take, including medicines for heart problems or high blood pressure; medicines that could increase their chance of infections, such as medicines to treat cancer or control their immune system; or ketoconazole (an antifungal) by mouth. If taken with Gilenya, serious side effects may occur. Patients should not get certain vaccines while taking Gilenya, and for at least 2 months after stopping.
The most common side effects with Gilenya were headache, flu, diarrhea, back pain, abnormal liver tests, and cough.
For full Prescribing Information and the Medication Guide log onto www.pharma.us.novartis.com.
Patients are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as “to raise awareness,” “to compete,” “to better understand,” “to create,” “will,” “to further support,” “committed,” or similar expressions, or by express or implied discussions regarding future revenues from Gilenya. You should not place undue reliance on these statements. Such forward-looking 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 with Gilenya 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; competition in general; government, industry and general public pricing pressures; thecompany’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 U.S. 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 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 2010, the Group’scontinuing operations achieved net sales of USD 50.6 billion, while approximately USD9.1 billion (USD 8.1 billion excluding impairment and amortization charges) was invested in R&D throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 119,000 full-time-equivalent associates (including 16,700 Alcon associates) and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com
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