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  1. 1. MM Presentations REBIF By, Shilpa C January 10, 2008
  2. 2. <ul><li>MS is a complex, multifaceted disease of the central nervous system (CNS) with multiple pathways. Approximately 400,000 people in the U.S. have MS. (2.5 million worldwide) </li></ul><ul><li>MS interferes with the brain’s ability to control such functions as seeing, walking & talking. It is unpredictable and every person with MS will have his or her unique set of symptoms. </li></ul><ul><li>It can be difficult to diagnose, although technologies like magnetic resonance imaging is improving the ability to diagnose and treat MS earlier. </li></ul><ul><li>MS is usually diagnosed between the ages of 20 and 40 and is twice as common among women as it is among men. </li></ul>Multiple Sclerosis
  3. 3. <ul><li>MS results in a thinning or complete loss of myelin and, less frequently, the cutting of the neuron's extensions or axons. When the myelin Is lost, the neurons can no longer effectively conduct their electrical signals. </li></ul><ul><li>Myelin acts as a type of insulation around the axon of nerves. In MS, demyelination is the result of an abnormal autoimmune reaction. </li></ul>Demyelination
  4. 6. Visualization of sclerotic plaques
  5. 7. <ul><li>Symptoms vary, ranging from mild to more severe, but most commonly include: blurred vision, problems with strength and coordination, and numbness or tingling in the limbs. </li></ul><ul><li>Clinical exacberations are characterized by a sudden worsening of symptoms, which can last at least for 24 hrs or can prolong to even few weeks or a month! Symptoms vary from one individual to the next, and also from one exacerbation to the next. </li></ul><ul><li>The most common form of MS is called relapsing-remitting MS, where symptoms come & go in a pattern of relapse and remittance over time. This is generally the first diagnosis of MS in the 20’s to 30’s. Approximately 85% of MS cases exhibit RRMS. </li></ul><ul><li>Women are twice as likely to have this diagnosis. </li></ul><ul><li>Other forms of MS are defined by the level of disability progression & the presence or absence of MS attacks. </li></ul>Symptoms & Forms of MS
  6. 8. <ul><li>Secondary Progressive (SPMS): About half of individuals with RRMS will develop this type of MS after a number of years. This starts out as RRMS, however over time there will not be real recovery after relapses, just a worsening progression of symptoms. Patients begin to have neurological decline between their acute attacks without any definite periods of remission. </li></ul><ul><li>Progressive Relapsing/Remitting (PRMS): It is characterized by a steady neurological decline along with superimposed attacks. Approximately 5% of MS cases exhibit PRMS. </li></ul><ul><li>Primary Progressive (PPMS): There will be steady increase in disability without clear relapses. Onset is generally around late 30’s to early 40’s. Individuals with this type of MS are less likely to suffer from brain damage. Approximately 10% of cases. </li></ul>Other Forms of MS
  7. 9. <ul><li>Rebif (interferon beta-1a) is indicated for the treatment of patients with relapsing forms of multiple sclerosis. Efficacy of Rebif in chronic progressive MS has not been established. Rebif is available in over 80 countries worldwide, and in the U.S. </li></ul><ul><li>Rebif is a purified glycoprotein, which is produced by recombinant DNA technology using genetically engineered Chinese Hamster Ovary cells into which the human interferon beta-1a gene has been introduced. </li></ul><ul><li>Rebif decreases the frequency of clinical exacerbations and delays the accumulation of physical disability. Rebif is used to treat RRMS, PRMS, and SPMS. </li></ul><ul><li>Rebif is formulated as a sterile solution in a pre-filled syringe intended for subcutaneous injection. Rebif is an injection that is given 3 times a week. </li></ul><ul><li>Rebif was approved by the U.S. FDA on March 7, 2002 for the treatment of relapsing forms of MS. </li></ul>Rebif
  8. 10. <ul><li>Dosages of Rebif shown to be safe and effective are 22 mcg and 44 mcg injected subcutaneously three times per week. </li></ul><ul><li>Rebif should be administered, if possible, at the same time (preferably in the late afternoon or evening) on the same three days (e.g. Monday, Wednesday, and Friday) with at least 48 hours of gap. </li></ul>Dosage & Administration of Rebif
  9. 11. Rebiject
  10. 12. <ul><li>The most commonly reported side effects of Rebif are: </li></ul><ul><li>Injection site disorders </li></ul><ul><li>Headache </li></ul><ul><li>Fatigue </li></ul><ul><li>Fever </li></ul><ul><li>Rigors </li></ul><ul><li>Chest pain </li></ul><ul><li>Back pain </li></ul><ul><li>Abdominal pain </li></ul><ul><li>Depression </li></ul><ul><li>Myalgia </li></ul>Side Effects of Rebif
  11. 13. <ul><li>Tysabri is approved as monotherapy treatment for relapsing forms of multiple sclerosis. (Biogen Idec and Elan Pharmaceuticals) Tysabri is administered by infusion (intravenous) </li></ul><ul><li>Betaferon/Betaseron is approved as monotherapy treatment for relapsing-forms of multiple sclerosis. In 2003, The FDA approved its use in people with secondary-progressive MS who continue to have relapses. (Bayer Healthcare Pharmaceuticals) </li></ul>Major Competitors
  12. 14. <ul><li>Avonex (interferon beta-1a) is approved by the FDA to treat relapsing forms of MS. (Biogen Idec) Avonex is once per week intramuscular injection. It is the leading MS therapy in the US, with around 40% of the overall market, and in Europe, with around 30% of the overall market. </li></ul><ul><li>Copaxone (glatiramer acetate injection) is indicated for the reduction of the frequency of relapses in relapsing-remitting multiple sclerosis. (Teva Pharmaceuticals) Copaxone is administered by subcutaneous injection at a dose of 20 mg per day. </li></ul>Major Competitors
  13. 15. <ul><li>Jordan Sigalet is an amazing person, who is not only a dedicated athlete but also wage the daily war against debilitating MS. He is a professional Canadian ice hockey player. Sigalet is a goaltender with the NHL's Boston Bruins. </li></ul><ul><li>Sigalet is now an ambassador for the Multiple Sclerosis Rhode Island chapter. </li></ul><ul><li>Sigalet is involved in a fundraiser supported by the Providence Bruins & medication Seriano called &quot;Sigalet Saves For MS&quot; that donates 20 dollars for every save he makes. </li></ul>For this goal tender, stopping the puck is only half the battle…! Jordan Sigalet
  14. 16. <ul><li>Teri Garr is an American actress and comedian. She has been diagnosed with MS. </li></ul><ul><li>She has become a leading advocate in raising awareness for MS and the latest treatments for the disease. </li></ul><ul><li>She is a National Ambassador for the National Multiple Sclerosis Society & National Chair for the Society's Women Against MS program. </li></ul>&quot;I'm telling my story for the first time, so that I can help people. I can help people know they aren't alone, and tell them there are reasons to be optimistic because today treatment options are available&quot;. Teri Garr
  15. 17. <ul><li>In August 2007, new and improved version of Rebif got approved in the EU,providing a little added protection to the Merck Serono’s MS franchise. </li></ul><ul><li>NICE officially recommended Tysabri for severe multiple sclerosis. </li></ul><ul><li>The CARE-MS I trial (Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis) initiated to compare Alemtuzumab to Rebif in patients with relapsing-remitting MS. (September 26, 2007) </li></ul><ul><li>A study suggested that Rebif is not superior to rival Teva's Copaxone (October 10, 2007) </li></ul><ul><li>The results of BRIGHT (Betaseron(R) versus Rebif(R) Investigating Higher Tolerability) study was announced on November 07, 2007. This study found Betaseron to cause less injection site pain but satisfaction with the treatment among MS patients was more for Rebif ! </li></ul><ul><li>Biogen Idec ended its strategic review and announced that it has decided to remain as an independent Company (December 12, 2007) </li></ul>Recent Issues
  16. 18. <ul><li>If you are alive, you are connected to the potential, the hope, and the momentum of it all. Multiple sclerosis may stop people from moving, but I feel if hope & will power exists, one can make sure MS does not stop him/her from moving on !!! </li></ul>