-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, IlTJ1YsGfkhurR95inDxUPhcRcV6JoflHQNrsGyncObVzlFcOEKNxgiaHvDBNiSi bGRaVQx86Q9vrYslemjtzA== 0001104659-08-041663.txt : 20080624 0001104659-08-041663.hdr.sgml : 20080624 20080624083857 ACCESSION NUMBER: 0001104659-08-041663 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20080624 ITEM INFORMATION: Entry into a Material Definitive Agreement FILED AS OF DATE: 20080624 DATE AS OF CHANGE: 20080624 FILER: COMPANY DATA: COMPANY CONFORMED NAME: GENZYME CORP CENTRAL INDEX KEY: 0000732485 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 061047163 STATE OF INCORPORATION: MA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-14680 FILM NUMBER: 08913404 BUSINESS ADDRESS: STREET 1: ONE KENDALL SQ CITY: CAMBRIDGE STATE: MA ZIP: 02139 BUSINESS PHONE: 6172527500 MAIL ADDRESS: STREET 1: ONE KENDALL SQUARE CITY: CAMBRIDGE STATE: MA ZIP: 02139 8-K 1 a08-17244_18k.htm 8-K

 

UNITED STATES
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

 

DATE OF REPORT (DATE OF EARLIEST EVENT REPORTED):

June 24, 2008

 

GENZYME CORPORATION

(Exact name of registrant as specified in its charter)

 

Massachusetts

 

0-14680

 

06-1047163

(State or other jurisdiction of
incorporation or organization)

 

(Commission file number)

 

(IRS employer identification
number)

 

500 Kendall Street, Cambridge, Massachusetts  02142

(Address of Principal Executive Offices)  (Zip Code)

 

Registrant’s telephone number, including area code:

(617) 252-7500

 

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 June 24, 2008, Genzyme Corporation (“Genzyme”) and Isis Pharmaceuticals, Inc. (“Isis”) entered into a license and co-development agreement for mipomersen (the “License Agreement”).  The License Agreement provides Genzyme with exclusive worldwide rights to mipomersen, a lipid-lowering drug targeting apolipoprotein B-100 that was discovered and developed by Isis and that is in phase 3 clinical development for patients with homozygous familial hypercholesterolemia (“FH”).  The License Agreement was negotiated pursuant to a strategic alliance that Genzyme and Isis entered into on January 7, 2008.

 

Under the License Agreement, Isis will receive a $175 million license fee for mipomersen.  In February, Isis received a $150 million payment from Genzyme to purchase 5 million shares of Isis common stock at $30 per share under the terms of the strategic alliance.

 

Under the License Agreement, over the next 30 days, the companies will transition the mipomersen IND and all regulatory authority to Genzyme.  As the sponsor of mipomersen, Genzyme will take the lead on discussions with regulatory agencies and filings.  In response to guidance received from the FDA, the companies have modified the initial development plan for mipomersen, subject to further discussions with the agency.

 

The key changes to the plan include:

 

·      The addition of clinical studies of mipomersen in apheresis-eligible patients.

 

·      Consolidation of the planned filings for heterozygous FH patients and other high-risk, high cholesterol patients into a single registration in the U.S.

 

·      Acceleration of the planned outcome study so that it can be used to support the above mentioned consolidated U.S. filing.

 

As a result of the changes in the development plan and consistent with the premise of the transaction in which the companies are sharing the value of mipomersen, the following changes to the original financial terms of the strategic alliance have been made:

 

·      Isis will contribute up to the first $125 million in development funding, reflecting an additional contribution of up to $50 million.  Thereafter Isis and Genzyme will share development costs equally.  The initial Isis development funding commitment and the shared funding will end when the program is profitable.  In exchange for this additional contribution, Isis has the opportunity to receive certain milestone payments early.

 

·      $75 million of the $150 million milestone associated with the heterozygous FH indication (the portion related to U.S. registration) may be accelerated, to be paid $25 million at annual product revenue of $250 million and $50 million at annual product revenue of $500 million.  The $75 million milestone for European approval of the heterozygous FH indication remains the same.

 

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All other financial terms of the transaction remain unchanged.  In addition to the up-front payments from Genzyme ($175 million license fee and the $150 million February 2008 stock purchase), Isis is eligible to receive up to $825 million in development and regulatory milestone payments plus up to $750 million in commercial milestone payments.

 

The development and regulatory milestones payments are broken out as follows:

 

·

 

Total milestones related to homozygous FH

 

US$  50 million

 

·

 

Total milestones related to heterozygous FH

 

US$150 million

 

 

 

- $75 million for U.S. approval (may be accelerated based on earlier achievement of sales targets)

 

 

 

 

 

- $75 million for E.U. approval

 

 

 

·

 

Total milestones related to approvals of a first Non-FH indication

 

US$375 million

 

·

 

Total milestones related to approvals of a follow-on product

 

US$250 million

 

 

 

TOTAL

 

US$825 million

 

 

 

 

 

 

 

The commercial milestones payments are broken out as follows:

 

 

 

 

 

·

 

Upon US$3 billion in annual sales for two consecutive years:

 

US$250 million

 

·

 

Upon US$4 billion in annual sales for two consecutive years:

 

US$250 million

 

·

 

Upon US$5 billion in annual sales for two consecutive years:

 

US$250 million

 

 

 

TOTAL

 

US$750 million

 

 

Isis and Genzyme will allocate responsibility for funding development expenses as described above.  Genzyme will be responsible for funding sales and marketing expenses until revenues are sufficient to cover them.

 

Genzyme and Isis will share mipomersen profits, beginning with a 70/30 Genzyme/Isis split. This split will adjust on a sliding scale, reaching 50/50 when annual revenues reach $2 billion.  As part of the strategic relationship, Genzyme will also have preferred access to future Isis drugs for central nervous system and certain rare diseases.

 

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SIGNATURE

 

                    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.

 

 

 

GENZYME CORPORATION

 

 

 

 

 

 

Dated: June 24, 2008

By:

/s/ Peter Wirth

 

 

Peter Wirth

 

 

Executive Vice President, Legal and Corporate
Development

 

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