Delaware (State or other jurisdiction of incorporation) |
0-19311 (Commission file number) |
33-0112644 (IRS Employer Identification No.) |
14 Cambridge Center, Cambridge, Massachusetts (Address of principal executive offices) |
02142 (Zip Code) |
o | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
o | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
o | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
o | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 8.01 Other Events. | ||||||||
SIGNATURES |
| The diagnosis was made based upon the detection of JC Virus (JCV) DNA in the cerebrospinal fluid (CSF) in the setting of clinical signs, symptoms and magnetic resonance imaging (MRI) findings consistent with the diagnosis of PML. | ||
| Background: |
- | Patient has a history of MS and prior disease modifying therapies, including beta-interferons and glatiramer acetate. | ||
- | Patient had also received prior therapy with methotrexate for a rheumatological condition. | ||
- | Patient received 14 infusions of TYSABRI monotherapy. | ||
- | Clinical vigilance led to early identification of signs and symptoms of possible PML and to clinical evaluation which included MRI scanning and CSF testing. | ||
- | Patient is under the care of patients treating physician. |
Biogen Idec Inc. |
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By: | /s/ Robert A. Licht | |||
Robert A. Licht | ||||
Vice President and Assistant Secretary |