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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
Securities Exchange Act of 1934
Date of Report:
August 9, 2005
(Date of earliest event reported)
Biogen Idec Inc.
(Exact Name of Registrant as Specified in Charter)
| Delaware | 0-19311 | 33-0112644 | ||
| (State or other Jurisdiction of Incorporation) |
(Commission File No.) | (IRS Employer Identification No.) |
14 Cambridge Center
Cambridge, Massachusetts 02142
(Address of principal executive offices, including zip code)
Cambridge, Massachusetts 02142
(Address of principal executive offices, including zip code)
(617) 679-2000
(Registrant’s telephone number, including area code)
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:
| 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 | ||||||||
| EXHIBIT INDEX | ||||||||
| EX-99.1 PRESS RELEASE DATED AUGUST 9, 2005 | ||||||||
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Item 8.01. OTHER EVENTS.
On August 9, 2005, Biogen Idec Inc. publicly disseminated a press release announcing an update of
its safety evaluation of TYSABRI® (natalizumab). 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 |
| Exhibit | ||
| Number | Description of Exhibit | |
99.1
|
Press Release, dated August 9, 2005, issued by Biogen Idec Inc. and Elan Corporation, plc |
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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/ Raymond G. Arner | |||
Date: August 11, 2005
|
Name: Raymond G. Arner | |||
| Title: Acting General Counsel | ||||
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EXHIBIT INDEX
| Exhibit | ||
| Number | Description of Exhibit | |
99.1
|
Press Release, dated August 9, 2005, issued by Biogen Idec Inc. and Elan Corporation, plc |
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 | |
Elizabeth Woo
|
Emer Reynolds | |
Ph: 617 679 2812
|
Ph: 353 1 709 4000 | |
| Chris Burns | ||
| 800 252 3526 |
BIOGEN
IDEC AND ELAN ANNOUNCE TYSABRI® SAFETY EVALUATION UPDATE
Cambridge, MA and Dublin, Ireland — August 9, 2005 - Biogen Idec (NASDAQ: BIIB) and Elan
Corporation, plc (NYSE: ELN) announced today that findings from their safety evaluation of
TYSABRI® (natalizumab) in patients with multiple sclerosis (MS) resulted in no new
confirmed cases of progressive multifocal leukoencephalopathy (PML). The companies have previously
reported three confirmed cases of PML, two of which were fatal. The ongoing safety evaluation in
Crohn’s disease and rheumatoid arthritis is on track to be completed by the end of the summer. The
companies anticipate making submissions to regulatory authorities in early fall of 2005. The
companies are taking preliminary steps to restart clinical trials in MS.
More than 2,000 MS patients from clinical trials were eligible for the safety evaluation. To date,
91% of these MS patients participated in the safety evaluation. The remaining 9% of patients did
not participate in the safety review. A total of 99% of patients participating in the evaluation
visited their treating physician and had a neurological exam. In addition, 98% of participants had
an MRI exam. The safety evaluation also included the review of any reports of potential PML in
patients receiving TYSABRI in the commercial setting.
“Our ongoing TYSABRI safety evaluation is a rigorous medical and scientific undertaking that has
been led by some of the world’s leading experts in neurology and neuroradiology,” said Whaijen Soo,
MD, PhD, senior vice president, Medical Research, Biogen Idec. “Given the high unmet medical need
in MS and the therapeutic benefit we have seen with TYSABRI, we are encouraged by these safety
findings.”
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Page 2 Biogen Idec and Elan Announce TYSABRI® Safety Evaluation Update
“The findings announced today are an important milestone in understanding the appropriate
benefit-risk profile for TYSABRI. Patient safety remains our top priority. We are committed to
finalizing the safety evaluation for Crohn’s disease and rheumatoid arthritis, which is progressing
well and on track to be completed by the end of the summer. We look forward to working with
regulatory authorities to determine the path forward for TYSABRI,” said Lars Ekman, MD, PhD,
executive vice president and president, Research and Development, Elan.
On February 28, 2005, Biogen Idec and Elan announced that they voluntarily suspended TYSABRI from
the U.S. market and all ongoing clinical trials based on reports of PML, a rare and potentially
fatal, demyelinating disease of the central nervous system. Biogen Idec and Elan’s comprehensive
safety evaluation concerning TYSABRI and any possible link to PML is ongoing. The results of this
safety evaluation will be discussed with regulatory agencies to determine the appropriate path
forward for TYSABRI.
Biogen Idec and Elan will host a webcast for the media and investment community at 8:30 a.m. EST
today to discuss the TYSABRI safety evaluation update. This webcast can be accessed through the
investor relations’ sections of the companies’ websites.
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 http://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 http://www.biogenidec.com.
About Elan
Elan Corporation, plc is a neuroscience-based biotechnology company. We are committed to making a difference in the lives of patients and their families by dedicating ourselves 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 http://www.elan.com
Elan Corporation, plc is a neuroscience-based biotechnology company. We are committed to making a difference in the lives of patients and their families by dedicating ourselves 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 http://www.elan.com
Safe Harbor/ Forward Looking Statements
This press release contains forward-looking statements regarding the potential, regulatory path forward, re-start of MS clinical trials and safety evaluation of TYSABRI. The potential, regulatory path forward and re-start of clinical trials for 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 concerns may arise from additional data or analysis, including the ongoing safety evaluation, or that the companies may encounter other unexpected delays or hurdles. There is also no assurance that the companies will be able to gain
This press release contains forward-looking statements regarding the potential, regulatory path forward, re-start of MS clinical trials and safety evaluation of TYSABRI. The potential, regulatory path forward and re-start of clinical trials for 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 concerns may arise from additional data or analysis, including the ongoing safety evaluation, or that the companies may encounter other unexpected delays or hurdles. There is also no assurance that the companies will be able to gain
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Page 3 Biogen Idec and Elan Announce TYSABRI® Safety Evaluation Update
sufficient information to fully understand the risks associated with TYSABRI or that the companies
will be able to resume marketing and sales of TYSABRI. The completion of the safety evaluation is
subject to a number of risks and uncertainties, including the difficulty of analyzing complex data
and results and unanticipated logistical hurdles. 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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