CAMBRIDGE, Mass., March 26 /PRNewswire-FirstCall/ -- Transkaryotic
Therapies, Inc. (Nasdaq: TKTX) today announced that Aventis Pharmaceuticals
Inc. has returned rights to Dynepo(TM) (epoetin delta) to TKT for all
indications in Europe and all other territories outside the United States.
Dynepo is a fully human erythropoietin product developed using TKT's patented
gene activation technology and is approved for the treatment of anemia
associated with kidney disease in the European Union.
"We are extremely pleased by today's agreement," said Michael J. Astrue,
President and Chief Executive Officer of TKT. "We intend to bring this
important product to patients in Europe and elsewhere as rapidly as we can and
will decide on a territory-by-territory basis how best to commercialize
Dynepo."
TKT is in the process of establishing contract manufacturing outside the
United States in order to bring Dynepo to patients in a manner consistent with
applicable court orders and regulatory requirements.
Under the revised agreement, TKT will pay Aventis a scaled royalty on
Dynepo sales. Aventis will retain rights to commercialize Dynepo in the
United States under essentially the same terms as the original agreement and
has obtained an option on certain TKT gene therapy technology for one year.
Additionally, TKT is no longer obligated to reimburse Aventis from future
royalties for legal expenses incurred to date from the Dynepo patent
infringement actions with Amgen in the United States and Kirin-Amgen in the
United Kingdom. TKT is responsible for any future litigation expenses in
Europe and half the future expenses in the United States. Additional details
about the patent litigation are available on the Legal News page of the TKT
corporate website (http://www.tktx.com/legal/index.htm).
Clinical testing involving approximately 1,400 dialysis and pre-dialysis
patients supported marketing approval of Dynepo in the European Union as a
treatment for anemia related to kidney disease. As described in the European
Public Assessment Report, treatment with Dynepo was comparable to epoetin alfa
and was effective in raising hemogloblin and hematocrit levels. In patients
treated with Dynepo, there have been no reported cases of pure red cell
aplasia, a condition in which the bone marrow fails to produce vital red blood
cells and a safety concern with other marketed erythropoietin products derived
from Chinese hamster ovary (CHO) cells.
Conference Call
TKT will host a conference call and live webcast today, March 26, 2004 at
1:30 p.m. Eastern Time to discuss its revised agreement with Aventis. To
participate by telephone, dial (973) 317-5319. A live audio webcast can be
accessed on the TKT website at http://www.tktx.com within the Investor Information
section. A replay of the call will be available for two weeks beginning at
4:30 p.m. Eastern Time on March 26, 2004 by dialing (973) 709-2089 and using
the access code: 347313. A replay of the webcast will be archived on the TKT
website for two weeks under Events in the Investor Information section.
About TKT
Transkaryotic Therapies, Inc. is a biopharmaceutical company primarily
focused on researching, developing and commercializing treatments for rare
diseases caused by protein deficiencies. Within this focus, the company
markets Replagal(TM), an enzyme replacement therapy for Fabry disease, and is
developing treatments for Hunter syndrome and Gaucher disease. Outside its
focus on rare diseases, TKT intends to commercialize Dynepo(TM), a Gene-
Activated(R) erythropoietin product for anemia related to kidney disease,
outside of the United States. TKT was founded in 1988 and is headquartered in
Cambridge, Massachusetts, with additional operations in Europe, Canada and
Latin America. Additional information about TKT is available on the company's
website at http://www.tktx.com.
This press release contains forward-looking statements regarding the
safety, efficacy and commercialization of Dynepo, 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 TKT's ability to re-establish
manufacturing will succeed; whether Dynepo will achieve commercial success;
whether Dynepo will continue to demonstrate the safety and efficacy profile
demonstrated to date; the availability and extent of coverage from third party
payors for Dynepo and receipt of reimbursement approvals for Dynepo; whether
competition products, including generic competition, will reduce any market
opportunity that may exist for Dynepo; whether Dynepo will be part of future
litigation that may impair its ability to market Dynepo; the company's ability
to bring Dynepo to patients consistent with legal considerations; whether
materials to be used in production will adequately substitute for materials
used in the original process; whether Amgen or Kirin-Amgen will challenge the
transfer of the regulatory file after receiving notification of the transfer
in accordance with the requirements of applicable court orders; and other
factors set forth under the caption "Certain Factors That May Affect Future
Results" in the company's Annual Report on Form 10-K for the year ended
December 31, 2003, which is on file with the Securities and Exchange
Commission and are incorporated herein by reference. While the company may
elect to update forward-looking statements at some point in the future, the
company specifically disclaims any obligation to do so, even if its
expectations change.
Gene-Activated(R) is a registered trademark and Replagal(TM) is a
trademark of Transkaryotic Therapies, Inc. Dynepo(TM) is a trademark of
Aventis.
CONTACTS:
Justine E. Koenigsberg Daniella M. Lutz
Director, Corporate Communications Corporate Communications Specialist
(617) 349-0271 (617) 349-0205
SOURCE Transkaryotic Therapies, Inc.
 back to top
Related links:
http://www.tktx.com
Photo Notes:
NewsCom:
http://www.newscom.com/cgi-bin/prnh/19990913/TKTLOGO
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, 888-776-6555 or 212-782-2840
Company News On-Call:
http://www.prnewswire.com/comp/120657.html
CONTACT:
Justine E. Koenigsberg, Director, Corporate
Communications, +1-617-349-0271, or Daniella M. Lutz, Corporate
Communications Specialist, +1-617-349-0205, both of TKT
|
