Chugai NMO Clinical Trial Webinar 8:00 a.m. PST, 11 a.m. EST Friday, 12/12/14. Sakura Star Study

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1 Chugai NMO Clinical Trial Webinar 8:00 a.m. PST, 11 a.m. EST Friday, 12/12/14 Sakura Star Study

2 Webinar Format Session is 45 minutes in length (Welcome, Intro, Presentation, Q&A) Attendees may submit questions in the Q&A window online - please be as succinct as possible if you choose to submit a question After the presentation is complete, the presenters & panelists will address as many questions as time allows Thank you for understanding that not all questions will be addressed Webinar slides and audio will be posted on the foundation Website for later viewing/audio.

3 Presenter Panelist Moderator Athos Gianella-Borradori, M.D. Chief Medical Officer Chugai Pharma USA Brian Weinshenker, M.D. Expert NMO Clinician Mayo Clinic Michael Yeaman, Ph.D. Advisor, The Guthy-Jackson Charitable Foundation

4 Presentation Format Content is solely that of the respective industry or its representative Presenters are afforded a maximum of minutes total time Questions / answers are then afforded up to 20 minutes of time The webinar is being recorded for purposes of future distribution All perspectives are offered only for stakeholder self-education The Guthy-Jackson Charitable Foundation does not perform clinical trials nor does it endorse any particular clinical trial design or drug

5 12-Dec-2014 Chugai Pharmaceuticals Study SA309-JG: anti IL-6 receptor antibody SA237 in subjects with NMO/NMOSD CONFIDENTIAL 5

6 CONFIDENTIAL Anti IL-6 Receptor Antibody SA237, Background Maintenance therapy has become standard practice for prevention of relapses of patients with NMO/NMOSD. IL-6 is a growth factor for cells producing antibodies that contribute to neuromyelitis optica symptoms. Small studies show activity of anti IL-6 receptor antibody tocilizumab (Actemra) in preventing NMO/NMOSD relapses. SA237 is an anti IL-6 receptor antibody Designed to improve IL-6 receptor blocking activity of tocilizumab Tocilizumab has been used for many years by subjects with arthritis and other autoimmune diseases. SA237 is an investigational agent currently being tested in clinical studies 6

7 CONFIDENTIAL SA237 is a Recycling Antibody SA237 circulates in the blood and binds to the IL-6 receptor on cell surface SA237 Recycled to the plasma instead of being degraded inside the cell IL-6 receptor Inside the cell SA237 releases IL-6 receptor which is degraded Investigator s meeting of SA-309JG study 7

8 CONFIDENTIAL Sakura Star Study: Eligible Participants Key Inclusion Criteria 1. NMO or NMOSD 2. Subjects of age 18 to 74 years 3. At least 1 documented relapse in last 12 months prior to screening 4. Disability score from 0 to 6.5 inclusive at screening Exclusion Criteria for General Safety 1. Pregnancy or lactation 2. Evidence of other demyelinating disease such as MS or progressive multifocal leukoencephalopathy 3. Active infection within 4 weeks prior to baseline 4. Recent treatments with strong immunosuppressive agents 8

9 CONFIDENTIAL Sakura Star Study Design: Key Elements Screening Period: up to 28 days for evaluation of study candidates Randomization: 2:1 SA237 single agent to pure placebo Duration of Study Treatment Periods: Double blind: lasting until subject experiences a relapse if no relapse approx. 1 year Open label SA237: starting immediately after first relapse for patients without relapse approx. after 1 year Frequency of Dosing and Study Visits: Weeks 0, 2, 4, and every 4 weeks thereafter 9

10 CONFIDENTIAL Efficacy Outcome Measures Time to 1 st relapse (TFR) in subjects receiving SA237 compared to subjects receiving placebo Subjects will be closely monitored and symptoms of a relapse will be rapidly assessed and treated 10

11 CONFIDENTIAL Efficacy Outcome Measures (cont.) Change in score for Pain Change in Fatigue Score Change in scores for Health Status Change in timed 25-foot Walk Change in severity of Disability Evaluations to better understand NMO/NMOSD and how SA237 works, performed at some selected sites: MRI scans of the brain, optic nerve, and spinal cord Immunological evaluations in blood and spinal fluid 11

12 Number of Patients CONFIDENTIAL Sakura Star Study Recruitment Objective 70 patients in 40 clinical study sites in the US and Canada 12

13 CONFIDENTIAL Summary Notes for Patients SA237 is administered under the skin (sub-cutaneous injection) 2:1 randomization of participants to SA237 or pure placebo until relapse, thereafter SA237 for all participants Greenphire ClinCard system used for payment: similar to a credit card that patients and caregivers can use for study related expenses such as travel, meals, accommodations. For participants who complete the study, SA237 will be made available free of charge up to FDA authorization to market. 13

14 CONFIDENTIAL SA237 and SAkura Star Study : Name and Logo Name of the investigational agent is SA237, which was discovered in Chugai Pharmaceutical laboratories in Japan, Sakura ( 桜 ), is the Japanese name of the Japanese Cherry Blossom, which is Japan s national flower, Yearly blooming of Sakura trees symbolises the return of life and is taken as an image for the return of SA237 recycling to the blood For more info about the SAkura Star clinical trial and SA237 go to or ask your doctor 14

15 CONFIDENTIAL 15

16 Questions

17 Learn More This webinar will be hosted on the foundation website at:

18 Conclusion Content is solely that of the respective industry or its representative Webinar slides and audio will be posted on the foundation website for later viewing / audio All perspectives are offered only for stakeholder self-education The Guthy-Jackson Charitable Foundation does not perform clinical trials nor does it endorse any particular clinical trial design or drug We hope this webinar has been informative to all stakeholders

Alexion NMO Clinical Trial Webinar 7:00 a.m. PST, 10 a.m. EST Friday, 12/12/14. The PREVENT Study

Alexion NMO Clinical Trial Webinar 7:00 a.m. PST, 10 a.m. EST Friday, 12/12/14 1 The PREVENT Study 2 Webinar Format Session is 45 minutes in length (Welcome, Intro, Presentation, Q&A) Attendees may submit