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Swedish Orphan Biovitrum's Agreement With Biogen Idec, Inc. (Massachusetts) (BIIB) Regarding Long-Lasting rFVIIIFc and rFIXFc Hemophilia Programs


2/6/2012 6:36:43 AM

STOCKHOLM, SWEDEN--(Marketwire - February 06, 2012) - Sobi and Biogen Idec have agreed to disclose further details on their agreement regarding development and commercialization of long-lasting recombinant factor VIII and factor IX hemophilia programs, which was restructured in February 2010. Under the new agreement, Biogen Idec assumed full development responsibilities and costs, as well as manufacturing rights. In addition, the cross-royalty rates were reduced and commercial rights for certain territories were changed.

Subject to the exercise of an option right, Sobi will have commercial rights in Europe, Russia, Turkey and certain countries in the Middle East (the Sobi territory). Biogen Idec has commercial rights for North America (the Biogen North American territory) and for rest of the world markets outside of Europe, Russia, Turkey and certain countries in the Middle East (the Biogen Direct territory).

Under the terms of the option right and following Biogen Idec's submission of a marketing authorization application to the European Medicines Agency (EMA) for each program, Sobi may opt to take over final regulatory approval, pre-launch and commercialization activities in the Sobi territory at a cost of USD 10.0 million per program.

Upon EMA regulatory approval of each program, Sobi will be liable to reimburse Biogen Idec 50% of the sum of all manufacturing and development expenses incurred by Biogen Idec from 1 October 2009 through the date on which Sobi is registered as the marketing authorization holder, as well as 100% of certain development expenses incurred exclusively for the benefit of the Sobi territory.

To effect Sobi's reimbursement to Biogen Idec for each program, the cross-royalty structure for direct sales in each company's respective territories will be adjusted until the consideration is paid in full. The mechanism for reimbursement is outlined in the table below.

In the event that Sobi exercises its option right, amounts under the amended agreement will become payable as follows:

+------------------+-----------+-------------+----------------------------+
|                  |           |             |Rates should Sobi exercise  |
|                  |           |             |its opt-in right            |
+------------------+-----------+-------------+--------------+-------------+
|                  |           |Rate prior to|Base rate     |             |
|Royalty and net   |           |first        |following     |Rate during  |
|revenue share     |Method     |commercial   |first         |reimbursement|
|rates             |           |sale         |commercial    |period       |
|                  |           |in Sobi's    |sale in Sobi's|             |
|                  |           |territory    |territory     |             |
+------------------+-----------+-------------+--------------+-------------+
|Sobi rate to      |           |             |              |             |
|Biogen Idec on net|           |             |              |             |
|sales             |Royalty    |N/A          |10 to 12%     |Base rate    |
|in the Sobi       |           |             |              |plus 5%      |
|territory         |           |             |              |             |
+------------------+-----------+-------------+--------------+-------------+
|Biogen Idec rate  |           |             |              |             |
|to Sobi on net    |           |             |              |             |
|sales in          |Royalty    |2%(3))       |10 to 12%     |Base rate    |
| the Biogen North |           |             |              |less 5%      |
|American territory|           |             |              |             |
+------------------+-----------+-------------+--------------+-------------+
|Biogen Idec rate  |           |             |              |             |
|to Sobi on net    |           |             |              |             |
|sales in          |Royalty    |2%(3))       |15 to 17%     |Base rate    |
|the Biogen Direct |           |             |              |less 5%      |
|territory         |           |             |              |             |
+------------------+-----------+-------------+--------------+-------------+
|Biogen Idec to    |           |             |              |             |
|Sobi on net       |           |             |              |             |
|revenue(1))       |Net revenue|10%          |50%           |Base rate    |
|in the Biogen     |share      |             |              |less 15%     |
|Distributor       |           |             |              |             |
|territory(2))     |           |             |              |             |
+------------------+-----------+-------------+--------------+-------------+

1. Net revenue represents Biogen Idec's pre-tax receipts from third-party distributors, less expenses incurred by Biogen Idec in the conduct of commercialization activities supporting the distributor activities.

2. The Biogen Distributor Territory represents Biogen territories where sales are derived utilizing a third-party distributor.

3. A credit will be issued to Sobi against its reimbursement of the Opt-in Consideration in an amount equal to the difference in the royalties paid by Biogen Idec to Sobi on sales in the Biogen territory for certain periods prior to the first commercial sale in the Sobi territory versus the rate that otherwise would have been payable on such sales.

If the reimbursement of the opt-in consideration has not been achieved within six years of the first commercial sale of the respective programs, Biogen Idec has the right to require Sobi to pay any remaining balances within 90 days of the six year anniversary date of the first commercial sale.

Should Sobi not exercise its option right with respect to one or both programs or should Sobi terminate the agreement with respect to one or both programs, Biogen Idec will obtain full worldwide development and commercialization rights for such affected program and will be obligated to pay royalties to Sobi subject to separate terms defined under the restructured collaboration agreement. In addition, if EMA approval for any program is not granted within 18 months of the applicable EMA filing date, Sobi shall have the right to require that the first opt-in payment be refunded and revoke its option right for such program.

The information in this press release has also been included in Biogen Idec's 10K report filed with the SEC (Securities and Exchange Commission) in the US.

Telephone conference

CEO Geoffrey McDonough and CFO Lars Sandström will be available for questions at 10:00 a.m. CET. Please call:

Sweden: +46 (0)8 505 598 12

UK: +44 (0)207 750 9950

USA: +1 866 676 58 69



Swedish Orphan Biovitrum (Sobi)

Sobi is a leading integrated biopharmaceutical company dedicated to bringing innovative therapies and services to improve the health of rare disease patients and their families. The product portfolio comprises about 60 marketed products as well as projects in the late clinical phase. Key therapeutic areas are Inflammation and Genetics & Metabolism. In 2010 Sobi had revenues of SEK 1.9 billion and around 500 employees. The share (STO: SOBI) is listed on OMX NASDAQ Stockholm. More information is available atwww.sobi.com.


The information above has been published pursuant to the Swedish Securities Market Act and/or the Financial Instruments Trading Act. The information was released for public distribution on 6 February 2012 at 8.00 a.m. CET.



Sobi Press Release February 6, 2012 in pdf format:

http://hugin.info/134557/R/1582735/494589.pdf

This announcement is distributed by Thomson Reuters on behalf of Thomson Reuters clients. The owner of this announcement warrants that:

(i) the releases contained herein are protected by copyright and other applicable laws; and

(ii) they are solely responsible for the content, accuracy and originality of the information contained therein.


[HUG#1582735]


For further information, please contact:
Asa Stenqvist
Head of Communications and Investor Relations
Tel.: +46 8 697 21 88


Read at BioSpace.com


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