Company Will Hold Conference Call Today at 11:00 a.m. Eastern
CAMBRIDGE, Mass.--(BUSINESS WIRE)--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
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.
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.