-- Companies Sign Global Legal Settlement --
CAMBRIDGE, Mass., Oct. 8 /PRNewswire-FirstCall/ -- Genzyme Corporation
(Nasdaq: GENZ) and Transkaryotic Therapies, Inc. (Nasdaq: TKTX) today
announced the companies have entered into an agreement under which Genzyme
will develop and commercialize iduronate-2-sulfatase (I2S), TKT's enzyme
replacement therapy for the treatment of Hunter syndrome, in Japan and other
Asia/Pacific territories and a broad litigation settlement agreement. TKT has
retained all rights in North America, Europe, and Latin America, and intends
to commercialize I2S directly in those territories.
Under the terms of the agreement, Genzyme will pay TKT approximately $3.0
million in upfront payments and other consideration. TKT also has the
potential to receive up to an additional $8 million relating to certain
regulatory and commercial milestones, primarily related to a regulatory
submission and approval in Japan. TKT will manufacture the bulk drug
substance for commercial sale in Genzyme's territories and will receive
payments that will equal approximately one-third of net sales in those
territories. In addition, Genzyme has options to obtain rights to certain
other research programs being developed by TKT in the territories where
Genzyme holds rights to I2S.
Henri A. Termeer, Chairman and Chief Executive Officer of Genzyme
Corporation, stated, "We look forward to working with TKT to improve the lives
of these desperately ill patients with Hunter syndrome. While the two
companies will continue to offer competing therapies for Fabry disease, we
will work collaboratively to address the very serious unmet medical needs of
Hunter patients."
Michael J. Astrue, President and Chief Executive Officer of TKT, said, "We
believe Genzyme's expertise in working with products of this profile in these
territories will add significant value to our Hunter syndrome program."
In addition, Genzyme and TKT have signed a global legal settlement
involving an exchange of non-suits between the companies. As part of this
exchange, Genzyme will withdraw from the patent suit brought against TKT in
July 2000 involving Replagal(TM) (agalsidase alfa), TKT's enzyme replacement
therapy for the treatment of Fabry disease. TKT has agreed not to initiate
any patent litigation relating to Aldurazyme(R) (laronidase), Genzyme's enzyme
replacement therapy for the treatment of MPS I, which is being commercialized
in a joint venture between Genzyme and BioMarin Pharmaceutical Inc. However,
in both situations, licensors of the patents at issue to Genzyme and TKT,
respectively, could continue or commence legal actions despite Genzyme and
TKT's legal settlement.
Conference Call and Webcast
In connection with this announcement, the management of Genzyme and TKT
will host a conference call and live audio webcast today, October 8, 2003, at
5:15 p.m. Eastern Time to discuss the agreement between Genzyme and TKT to
develop I2S in Japan as well as the legal settlement. Participants may access
the call by dialing (719) 457-2658. The live webcast may be accessed in the
Investor Information section of both the Genzyme and TKT websites at
http://www.genzyme.com or http://www.tktx.com, respectively.
A replay of this conference call will be available for one week beginning
today, October 8, 2003, at 8:15 p.m. Eastern Time, by dialing (719) 457-0820
and using the access code 379859. A replay of the webcast will be archived on
both the Genzyme and TKT websites in the companies' respective Investor
Information sections for one week.
About I2S
I2S is TKT's human iduronate-2-sulfatase produced by genetic engineering
technology intended for long-term treatment of Hunter syndrome. The rationale
for the therapy is that I2S would replace enzyme that is deficient in patients
with Hunter syndrome and either stop or reverse disease progression. I2S has
been designated an orphan drug in both the United States and Europe and is the
only known enzyme replacement therapy in development for the treatment of
Hunter syndrome. In September, TKT commenced a multi-national pivotal Phase
III clinical trial evaluating I2S in 90 patients with Hunter syndrome. If the
results of the study are positive, TKT intends to file for regulatory approval
in the United States and Europe in 2005.
About Hunter Syndrome
Hunter syndrome is a genetic disorder, also referred to as MPS II. This
hereditary disorder is characterized by the body's inability to produce the
enzyme iduronate-2-sulfatase, which is essential in the continuous process of
replacing and breaking down glycosaminoglycans (GAG). As a result, GAG remain
stored in cells in the body causing progressive damage. The symptoms of
Hunter syndrome are usually not visible at birth, but usually start to become
noticeable after the first year of life. Often the first symptoms may include
hernias, frequent ear infections, runny noses, and abnormal facial appearance.
As the disease progresses, a variety of symptoms appear including, enlarged
liver and spleen, heart failure, obstructive airway disease, sleep apnea,
joint stiffness, and, in the severe form, central nervous system involvement.
In severe cases, the life expectancy for patients with Hunter syndrome is
typically 10-15 years of age. However, in the attenuated form of the disease,
patients can survive into the fifth or sixth decade of life. TKT believes
there are up to 2,000 patients worldwide afflicted with Hunter syndrome in
jurisdictions where reimbursement may be possible.
About Genzyme
Genzyme Corporation is a global biotechnology company dedicated to making
a major positive impact on the lives of people with serious diseases and
medical conditions. This commitment has driven innovation in treating both
widespread diseases and rare genetic conditions, in providing leading
diagnostic products and services, in bringing the benefits of biotechnology to
the practice of surgery, and in developing novel approaches to cancer.
Genzyme's 5,300 employees worldwide serve patients in more than 80 countries.
About TKT
TKT is a biopharmaceutical company developing therapeutics for the
treatment of rare genetic diseases caused by protein deficiencies. The company
currently markets one product, Replagal(TM) (agalsidase alfa) for the
treatment of Fabry disease in the European Union and certain other countries.
TKT is headquartered in Cambridge, Massachusetts and has a majority-owned
subsidiary in Sweden, TKT Europe-5S AB, which is responsible for European
sales and marketing activities of Replagal. Additional information on TKT is
available on the company's website at http://www.tktx.com.
This press release contains forward-looking statements that involve a
number of risks and uncertainties, including statements regarding the
development and potential commercialization of I2S, potential milestone
payments related to I2S, manufacturing commercialization plans for I2S,
potential grants of additional rights to other programs by TKT to Genzyme
pursuant to options, the anticipated timing of filings for regulatory
approvals for I2S in the U.S. and Europe, estimates concerning the Hunters
syndrome patient population , as well as statements containing the words
"believes," "anticipates," "plans," "expects," "estimates," "intends,"
"should," "could," "will," "may," and similar expressions. There are a number
of important factors that could cause the company's actual results to differ
materially from those indicated by such forward-looking statements, including:
whether I2S will be safe and effective as a treatment for Hunter syndrome;
whether TKT is able to complete clinical trials of I2S; enrollment rates for
clinical trials; whether the results of clinical trials will be indicative of
results obtained in later clinical trials; whether future trials of I2S will
be conducted and conducted on a timely basis; the ability of the companies to
successfully complete development of I2S; the ability of TKT to manufacture
sufficient quantities of I2S for both companies' development and
commercialization activities and to do so in a cost efficient and timely
manner; the content and timing of submissions to and decisions by regulatory
authorities in the United States, Europe, Japan and other countries regarding
clinical trials and marketing and other applications for I2S; whether the FDA
and equivalent regulatory authorities grant marketing approval for I2S on a
timeline consistent with TKT's expectations or at all; whether, if approved,
I2S will achieve commercial success; the availability and extent of coverage
from third party payors for I2S and the receipt of reimbursement approvals for
I2S; whether competing products will reduce any market opportunity that may
exist for I2S; the accuracy of information about the Hunters syndrome patient
population; and other factors set forth under the caption "Certain Factors
That May Affect Future Results" in TKT's Quarterly Report on Form 10-Q for the
quarter ended June 30, 2003 and in Exhibit 99.2 to Genzyme's Annual Report on
Form 10-K for the year ended December 31, 2002, as amended. We caution
investors not to place undue reliance on the forward-looking statements
contained in this press release. These statements speak only as of the date
of this press release, and while the companies may elect to update these
forward-looking statements at some point in the future, TKT and Genzyme each
specifically disclaim any obligation to do so, even if their respective
expectations change.
Genzyme(R) is a registered trademark of Genzyme Corporation.
Aldurazyme(R) is a registered trademark of BioMarin/Genzyme LLC.
Replagal(TM) is a trademark of Transkaryotic Therapies, Inc.
All rights reserved.
Genzyme Contacts:
Sally Curley (investors)
617-591-7140
Bo Piela (media)
617-252-7785
TKT Contact:
Justine E. Koenigsberg (investors and media)
617-349-0271
SOURCE Transkaryotic Therapies, Inc.
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Related links:
http://www.tktx.com
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Company News On-Call:
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CONTACT:
Genzyme Contacts: Sally Curley (investors),
+1-617-591-7140, or Bo Piela (media), +1-617-252-7785, both of
Genzyme; or TKT Contact: Justine E. Koenigsberg (investors and
media) of TKT, +1-617-349-0271
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