MS Study Evaluating Safety and Efficacy of Two Doses of Fingolimod Versus Copaxone

This is a multicenter, randomized, rater- and dose-blinded, study to compare the efficacy and
safety of 0.25 mg and 0.5 mg of fingolimod with glatimer acetate 20 mg s.c. in patients with
RRMS.

This study will consist of 3 periods:

- Screening Period: up to 1 month for all patients

- Treatment Period: 12 months of glatiramer acetate 20 mg, fingolimod 0.25 mg, or
fingolimod 0.5 mg

- Follow-up will occur 3 months (12 weeks) after the last dose of study drug for all
patients

After signing the informed consent, patients will enter the Screening Period to determine
eligibility for the study. After inclusion/exclusion criteria are reviewed again and after
safety assessments are conducted, patients will enter the Treatment Period and will be
randomly assigned into 1 of 3 groups in a 1:1:1 ratio:

- Group 1 will receive fingolimod 0.5 mg orally once a day for up to 12 months

- Group 2 will receive fingolimod 0.25 mg orally once a day for up to 12 months

- Group 3 will receive glatiramer acetate 20 mg subcutaneously once a day for up to 12
months

Inclusion criteria:

- Written informed consent must be obtained before any assessment is performed

- Male and female patients 18 to 65 years of age, inclusive.

- Patients with RRMS, as defined by 2010 revised McDonald criteria.

- Patients must be neurologically stable with no onset of relapse or any steroid use
within 30 days of randomization

- Patients with at least 1 documented relapse during the previous year or 2 documented
relapses during the previous 2 years before randomization.

- Patients with an EDSS score of 0 to 6 inclusive at Screening. A score of 6.0 indicates
unilateral assistance (cane or crutch) required to walk at least 100 meters with or
without resting.

- Patients treated with interferon beta or glatimer acetate can continue their treatment
until randomization

Exclusion criteria:

- Patients with a history of malignancy of any organ system (other than cutaneous basal
cell carcinoma)

- Patients with an active chronic disease (or stable but treated with immune therapy) of
the immune system other than MS (e.g., rheumatoid arthritis, scleroderma, Sjogren's
syndrome, Crohn's disease, ulcerative colitis) or with a known immunodeficiency
syndrome (HIV-antibody positive, AIDS, hereditary immune deficiency, drug-induced
immune deficiency).

- Patients who have been treated with:

- High-dose intravenous (IV) immunoglobulin (Ig) within 2 months before randomization

- Immunosuppressive/chemotherapeutic medications (e.g., azathioprine, cyclophosphamide,
methotrexate) within 6 months before randomization

- Monoclonal antibodies (including natalizumab) within 6 months before randomization

- Rituximab, alemtuzumab, ofatumumab, ocrelizumab, mitoxantrone or cladribine at any
time before randomization

- Patients who have been treated with corticosteroids or adrenocorticotropic hormones in
the past 30 days before the screening visit

- Patients with uncontrolled diabetes mellitus (HbA1c >7%)

- Patients with a diagnosis of macular edema during Screening (patients with a history
of macular edema will be allowed to enter the study provided that they do not have
macular edema at Screening)

- Positive screening for serological markers for hepatitis A, B, C, and E indicating
acute or chronic infection:

- Patients who are negative for varicella zoster virus IgG antibodies at Screening

- Patients who have received any live or live attenuated vaccines (including for
varicella zoster virus, herpes simplex, or measles) within 1 month before
randomization

- Patients who have received total lymphoid irradiation or bone marrow transplantation

- Patients with any unstable medical/psychiatric condition, as assessed by the primary
treating physician at each site