On January 26th, Amgen announced the acquisition of Micromet, based on the promise of blinatumomab and the BiTE technology platform. In this report, we review the blinatumomab program, the regulatory path to approval and its commercial prospects in acute lymphoblastic leukemia, as well as in B-cell non-Hodgkin’s lymphoma, a much larger opportunity, yet one where blinatumomab may face greater clinical development challenges, regulatory risk and competition. Blinatumomab’s importance transcends the specific indications discussed herein - it is also a bellweather for Micromet’s BiTE technology platform as well as bispecific antibodies in general, which are in development by other companies.

Date: January 26th

Number of pages:

Author: Dr. Ilana Fogelman

TABLE OF CONTENTS
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INTRODUCTION AND BACKGROUND
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1. Types of leukemia
2. Acute Lymphoblastic Leukemia (ALL)
- Epidemiology
- B-cell vs T-cell precursors
- The disease and the clinical picture
3. Risk factors and prognosis
4. Current treatments
5. The importance of minimal residual disease (MRD)
6. Other hematologic malignancies derived from B cells

BLINATUMOMAB
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1. Phase II Study in adult ALL patients with MRD
2. Phase II trial in relapsed/refractory ALL
3. Pediatric ALL
4. Pivotal Phase II and III trials in ALL
- European regulatory path
- US regulatory path
5. Phase I NHL Study
6. Update from the 53rd ASH meeting

CLINICAL AND REGULATORY DISCUSSION
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1. BiTE technology platform – how good is it?
2. CD19 as a therapeutic target for treating B-cell malignancies
3. How does a bispecific compare to a naked antibody in terms of potency?
4. The unmet need in ALL
5. Is blinatumomab active in ALL?
6. Regulatory pathway in leukemia
- CR as a primary endpoint
- MRD as an endpoint
7. What is the likelihood of FDA approval for blinatumomab in ALL?
8. What is the unmet medical need in NHL?
9. The risk/benefit ratio is much different in NHL

THE MARKET
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1. The ALL Opportunity
2. The NHL market opportunity

COMPETITION
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1. Other targeted therapies in development for ALL

SUMMARY OPINION
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