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): October 19, 2010
Biogen Idec Inc.
(Exact name of registrant as specified in its charter)
Delaware (State or other jurisdiction of incorporation) |
0-19311 (Commission file number) |
33-0112644 (IRS Employer Identification No.) |
133 Boston Post Road, Weston, Massachusetts (Address of principal executive offices) |
02493 (Zip Code) |
Registrants telephone number, including area code: (781) 464-2000
Not Applicable
(Former name or former address, if changed since last report)
(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)) |
Item 1.01 | Entry into a Material Definitive Agreement. |
On
October 19, 2010, Biogen Idec Inc. and Genentech, Inc., a wholly
owned member of the Roche Group,
amended and restated their Amended and Restated Collaboration
Agreement dated June 19, 2003 with regard to the development of
ocrelizumab, a humanized anti-CD20 antibody, and
agreed to terms for the development of GA101, a next-generation anti-CD20 antibody, as summarized
below.
Ocrelizumab
Genentech
will have responsibility for the further development and
commercialization of ocrelizumab in multiple sclerosis and will fund
all of the related costs going forward. Biogen Idec
will be entitled to receive tiered royalties between 13.5% and 24%
on U.S. sales of ocrelizumab. Commercialization of ocrelizumab will not impact Biogen Idecs percentage of the co-promotion
profits for RITUXAN® (rituximab).
GA101
Biogen
Idec will increase its share of the losses and profits related to the
development and commercialization of GA101 in the U.S.
Biogen Idec will pay 35% of the development and commercialization expenses of GA101 and will
receive between 35% and 39% of the profits of GA101 based upon the achievement of certain sales
milestones. To date, Biogen Idec had paid 30% of the GA101 development
expenses. Biogen Idec will pay
approximately $10 million to compensate Genentech for Biogen
Idecs increased share of such previously incurred expenses.
Commercialization of GA101 will impact Biogen Idecs percentage of the
co-promotion profits for RITUXAN, as summarized in the table below.
RITUXAN
Biogen Idecs current pretax co-promotion profit-sharing formula, which resets annually,
provides for a 30% share of the first $50 million of co-promotion operating profits for RITUXAN in
the U.S. and Canada and a 40% share of such profits in excess of $50 million. Biogen Idecs share
of the co-promotion profits for RITUXAN will change, as summarized in the table below, upon the
following events:
| First New Product FDA Approval: the FDAs first approval of an anti-CD20 product other than ocrelizumab and GA101 that is acquired or developed by Genentech and is subject to the collaboration agreement (New Product). |
| First Non-CLL GA101 FDA Approval: the FDAs first approval of GA101 in an indication other than chronic lymphocytic leukemia. |
| GA101 CLL Sales Trigger: the first day of the quarter after U.S. gross sales of GA101 in any consecutive 12 month period reach $500,000,000. |
Biogen Idecs Share of the Co-promotion Operating Profits for RITUXAN
Before First New Product FDA Approval | ||||||||||||||||||
After First New | First Non-CLL GA101 | GA101 CLL Sales | ||||||||||||||||
Product FDA | FDA Approval Occurs | Trigger Occurs | ||||||||||||||||
Co-promotion Operating Profits | Approval | First | First | |||||||||||||||
I. | First $50,000,000 | 30 | % | 30 | % | 30 | % | |||||||||||
II. | Above $50,000,000 | | | 35 | % | |||||||||||||
A. | Until First GA101 Threshold Date | 38 | % | 39 | % | | ||||||||||||
B. | After First GA101 Threshold Date | | | | ||||||||||||||
1(a). | Until First Threshold Date | 37.5 | % | | | |||||||||||||
1(b). | After First Threshold Date and until Second Threshold Date | 35 | % | | | |||||||||||||
1(c). | After Second Threshold Date | 30 | % | | | |||||||||||||
2. | Until Second GA101 Threshold Date | | 37.5 | % | | |||||||||||||
C. | After Second GA101 Threshold Date | | 35 | % | |
| First GA101 Threshold Date means the earlier of (1) the date of the First Non-CLL GA101 FDA Approval if U.S. gross sales of GA101 for the preceding consecutive 12 month period reach $150,000,000 or (2) the first day of the calendar quarter following the date following the First Non-CLL GA101 FDA Approval that U.S. gross sales of GA101 within any consecutive 12 month period have reached $150,000,000. | |
Second GA101 Threshold Date means the first day of the calendar quarter after U.S. gross sales of GA101 within any consecutive 12 month period have reached $500,000,000. | ||
First Threshold Date means the earlier of (1) the GA101 CLL Sales Trigger, (2) the Second GA101 Threshold Date and (3) the later of (a) the first date that U.S. gross sales of New Products in any calendar year reach $150,000,000 and (b) January 1 of the calendar year following the calendar year in which the First New Product FDA Approval occurs if gross sales of New Products reached $150,000,000 within the same calendar year in which the First New Product FDA Approval occurred. | ||
Second Threshold Date means the later of (1) the first date that U.S. gross sales of New Products in any calendar year reach $350,000,000 and (2) January 1 of the calendar year following the calendar year in which the First Threshold Date occurs. |
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/ Robert A. Licht | |||
Robert A. Licht | ||||
Senior Vice President | ||||
Date:
October 21, 2010