-----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, OovquuGfFnTv+2P6Vy6tEzLZI7nWtTQJO3LazyDTE/yErl4NiaxI0NNwV86K/Ndp vMQsOJABVwCu0jjHdg/3KQ== 0001157523-10-001697.txt : 20100324 0001157523-10-001697.hdr.sgml : 20100324 20100324100938 ACCESSION NUMBER: 0001157523-10-001697 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20100324 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20100324 DATE AS OF CHANGE: 20100324 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: 10700790 BUSINESS ADDRESS: STREET 1: 500 KENDALL STREET CITY: CAMBRIDGE STATE: MA ZIP: 02142 BUSINESS PHONE: 6172527500 MAIL ADDRESS: STREET 1: 500 KENDALL STREET CITY: CAMBRIDGE STATE: MA ZIP: 02142 8-K 1 a6226133.htm GENZYME CORPORATION 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):
March 24, 2010


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):

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))


Item 8.01 Other Events.

On March 24, 2010, Genzyme Corporation issued a press release announcing FDA enforcement action regarding the Company’s Allston plant.  A copy of the press release is attached as Exhibit 99.1 and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d)   Exhibits
 
99.1 Press Release of Genzyme Corporation dated March 24, 2010

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:

March 24, 2010

By:

/s/ Peter Wirth

Peter Wirth

Executive Vice President, Legal & Corporate

Development


EXHIBIT INDEX

Exhibit
Number


 

Description


99.1 Press Release of Genzyme Corporation dated March 24, 2010.

EX-99.1 2 a6226133ex991.htm EXHIBIT 99.1

Exhibit 99.1

Genzyme Announces FDA Enforcement Action Regarding Allston Plant

Company Will Hold Conference Call Today at 11:00 a.m. Eastern

CAMBRIDGE, Mass.--(BUSINESS WIRE)--March 24, 2010--Genzyme Corporation (NASDAQ: GENZ) announced today that the FDA notified the company yesterday afternoon that, while the agency recognizes Genzyme’s efforts, it intends to take enforcement action to ensure that products manufactured at the plant are made in compliance with good manufacturing practice regulations. The FDA enforcement action will likely result in a consent decree, under which a third party would inspect and review the plant’s operation for an extended period and certify compliance with FDA regulations. Under a consent decree, Genzyme also would be required to make payments to the government and could incur other costs.

Based on its initial communication with the agency and the medical need for patients, Genzyme expects that shipments of Cerezyme® (imiglucerase for injection) and Fabrazyme® (agalsidase beta), which are manufactured in Allston, will continue uninterrupted during the period of the enforcement action. In addition, Genzyme expects that shipments of Myozyme® (alglucosidase alfa) produced at the 160-L scale, which is filled and finished in Allston, will continue uninterrupted. Genzyme also fills and finishes Thyrogen® (thyrotropin alfa for injection) at the Allston plant and intends to discuss with the agency the company’s view that there is also a patient need for uninterrupted supply of this product. The discussions with the FDA are expected to occur over the next several weeks.

Genzyme will work cooperatively with the FDA to restore the agency’s confidence in its ability to operate the Allston plant at the highest standards, building on the progress it has made over the past year to address the manufacturing deficiencies at the Allston plant. This progress includes:

  • Retaining a leading quality assurance advisory firm to help develop a comprehensive strategy and risk mitigation plan. More than 30 expert consultants from this firm are currently working at the Allston plant or at other Genzyme manufacturing facilities.
  • Naming a new site head and reorganizing and strengthening the management team at the facility.
  • Hiring two highly regarded industry veterans to serve as President of Global Manufacturing and Corporate Operations and Senior Vice President of Global Product Quality.

About Genzyme

One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 12,000 employees in locations spanning the globe and 2009 revenues of $4.5 billion.

With many established products and services helping patients in approximately 100 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant and immune disease, and diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as cardiovascular disease, neurodegenerative diseases, and other areas of unmet medical need.

This press release contains forwarding-looking statements regarding the potential FDA enforcement action, including that an action will result in a consent decree and that shipments of Cerezyme® (imiglucerase for injection), Fabrazyme® (agalsidase beta), and Myozyme® (alglucosidase alfa) produced at the 160-L scale will continue uninterrupted, and the timing of discussions with the FDA. These statements are subject to risks and uncertainties that may cause actual results to differ materially. These risks and uncertainties include, among others, that Genzyme may be unable to reach agreement with the FDA on the terms of a consent decree and that the terms of such a consent decree may differ from Genzyme's current expectations, as well as the risks and uncertainties described in Genzyme's SEC reports filed under the Securities Exchange Act of 1934, including the factors discussed under the caption "Risk Factors" in Management's Discussion and Analysis of Genzyme Corporation and Subsidiaries' Financial Condition and Results of Operations in Part II, Item 7 of Genzyme's Annual Report on Form 10-K. Genzyme cautions investors not to place substantial reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this release, and Genzyme undertakes no obligation to update or revise them.

Genzyme®, Cerezyme®, Fabrazyme®, Myozyme® and Thyrogen® are registered trademarks of Genzyme Corporation. All rights reserved.

Genzyme’s press releases and other company information are available at www.genzyme.com and by calling Genzyme’s investor information line at 1-800-905-4369 within the United States or 1-678-999-4572 outside the United States.

Conference Call Information

Genzyme will host a conference call today at 11 a.m. Eastern. To participate in the call, please dial 773-799-3828 and refer to pass code “Genzyme.” A replay of this call will be available by dialing 203-369-0637. This call will also be Webcast live on the investor events section of www.genzyme.com. A replay of the Webcast will be available.

CONTACT:
Genzyme Corporation
Media Contact:
Bo Piela, 617-768-6579
bo.piela@genzyme.com
or
Investor Contact:
Patrick Flanigan, 617-768-6563
patrick.flanigan@genzyme.com

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