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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934
Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 8, 2006
| Biogen Idec Inc. | ||
| (Exact name of registrant as specified in its charter) | ||
| Delaware | 0-19311 | 33-0112644 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
||
| 14 Cambridge Center, Cambridge, Massachusetts | 02142 | |
| (Address of principal executive offices) | (Zip Code) | |
Registrant’s telephone number, including area code: (617) 679-2000
| Not Applicable | ||
| (Former name or former address, if changed since last report) | ||
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions (see General Instruction
A.2. below):
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))
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| Item 8.01 Other Events | ||||||||
| Item 9.01 Financial Statements and Exhibits | ||||||||
| SIGNATURES | ||||||||
| Ex-99.1 Press Release dated March 8, 2006 | ||||||||
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Item 8.01 Other Events
On March 8, 2006, the Registrant and Elan Corporation, plc publicly disseminated a press
release announcing that the Peripheral and Central Nervous System Drugs Advisory Committee of the
U.S. Food and Drug Administration voted unanimously to recommend reintroduction of
TYSABRI® (natalizumab) as a treatment for relapsing forms of multiple sclerosis. The
information contained in the press release is incorporated herein by reference and filed as Exhibit
99.1 hereto.
Item 9.01 Financial Statements and Exhibits
| (c) | Exhibits. | |
| 99.1 The Registrant’s Press Release dated March 8, 2006. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Biogen Idec Inc. |
||||
| By: | /s/ Susan H. Alexander | |||
| Susan H. Alexander | ||||
| Executive Vice President, General Counsel | ||||
Date: March 9, 2006
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EXHIBIT INDEX
| Exhibit Number | Description | |
99.1
|
The Registrant’s Press Release dated March 8, 2006 |
Exhibit 99.1
|
 |
|
For More Information Contact: |
||
MEDIA CONTACTS: |
||
Biogen Idec
|
Elan | |
Amy Brockelman
|
Davia B. Temin | |
Ph: 617 914 6524
|
Ph: 212 407 5740 | |
`
|
Elizabeth Headon | |
| 353-1-498-0300 | ||
INVESTOR CONTACTS: |
||
Biogen Idec
|
Elan | |
Oscar Velastegui
|
Emer Reynolds | |
Ph: 617 679 2812
|
Ph: 353 1 709 4000 | |
| Chris Burns | ||
| 800 252 3526 | ||
FDA ADVISORY COMMITTEE UNANIMOUSLY RECOMMENDS REINTRODUCTION OF TYSABRI® FOR THE
TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS
TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS
GAITHERSBURG, MD – March 8, 2006 – Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN)
announced today that the Peripheral and Central Nervous System Drugs Advisory Committee of the U.S.
Food and Drug Administration (FDA) voted unanimously to recommend reintroduction of
TYSABRI® (natalizumab) as a treatment for relapsing forms of multiple sclerosis (MS).
The Committee’s recommendation is advisory to the FDA, and the agency is not bound by this
recommendation. The FDA has designated TYSABRI for Priority Review, a status for products that are
considered to be significant therapeutic advancements over existing therapies that address an unmet
medical need. Biogen Idec and Elan will continue to work closely with the FDA in the weeks ahead
with the goal of making TYSABRI available. Discussions with FDA will include, among other things,
finalizing the details of the TYSABRI risk management plan. The companies anticipate action by the
FDA by March 29, 2006.
About Biogen Idec
Biogen Idec creates new standards of care in oncology, neurology and immunology. As a global leader in the development, manufacturing, and commercialization of novel therapies, Biogen Idec transforms scientific discoveries into advances in human healthcare. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.
Biogen Idec creates new standards of care in oncology, neurology and immunology. As a global leader in the development, manufacturing, and commercialization of novel therapies, Biogen Idec transforms scientific discoveries into advances in human healthcare. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.
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FDA Advisory Committee
Unanimously Recommends Reintroduction of TYSABRI®
About Elan
Elan Corporation, plc is a neuroscience-based biotechnology company committed to making a difference in the lives of patients and their families by dedicating itself to bringing innovations in science to fill significant unmet medical needs that continue to exist around the world. Elan shares trade on the New York, London and Dublin Stock Exchanges. For additional information about the company, please visit www.elan.com.
Elan Corporation, plc is a neuroscience-based biotechnology company committed to making a difference in the lives of patients and their families by dedicating itself to bringing innovations in science to fill significant unmet medical needs that continue to exist around the world. Elan shares trade on the New York, London and Dublin Stock Exchanges. For additional information about the company, please visit www.elan.com.
Safe Harbor/Forward Looking Statements
This press release contains forward-looking statements regarding the potential and regulatory path forward of TYSABRI. The commercial potential and regulatory path forward of TYSABRI are subject to a number of risks and uncertainties. Factors which could cause actual results to differ materially from the companies’ current expectations include the risk that we may unable to adequately address concerns or questions raised by FDA or European regulatory authorities during the regulatory review process, that concerns may arise from additional data or analysis, or that the companies may encounter other unexpected delays or hurdles. There is also no assurance that the companies will be able to resume marketing and sales of TYSABRI. Drug development and commercialization involves a high degree of risk. For more detailed information on the risks and uncertainties associated with the companies’ drug development and other activities, see the periodic reports that Biogen Idec and Elan have filed with the Securities and Exchange Commission. The companies assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
This press release contains forward-looking statements regarding the potential and regulatory path forward of TYSABRI. The commercial potential and regulatory path forward of TYSABRI are subject to a number of risks and uncertainties. Factors which could cause actual results to differ materially from the companies’ current expectations include the risk that we may unable to adequately address concerns or questions raised by FDA or European regulatory authorities during the regulatory review process, that concerns may arise from additional data or analysis, or that the companies may encounter other unexpected delays or hurdles. There is also no assurance that the companies will be able to resume marketing and sales of TYSABRI. Drug development and commercialization involves a high degree of risk. For more detailed information on the risks and uncertainties associated with the companies’ drug development and other activities, see the periodic reports that Biogen Idec and Elan have filed with the Securities and Exchange Commission. The companies assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
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