-----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, BJa34xkNkU3Rnq7W0tS7bT8pWz/ILI0Oa2y0hyBlztqkYB+Z9v5Trqg50hWcyDot d0EvKKZpRrXZJqvF71xUFA== 0001104659-04-008658.txt : 20040329 0001104659-04-008658.hdr.sgml : 20040329 20040329103437 ACCESSION NUMBER: 0001104659-04-008658 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20040326 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20040329 FILER: COMPANY DATA: COMPANY CONFORMED NAME: TRANSKARYOTIC THERAPIES INC CENTRAL INDEX KEY: 0000885259 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 043027191 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-21481 FILM NUMBER: 04694816 BUSINESS ADDRESS: STREET 1: 195 ALBANY ST CITY: CAMBRIDGE STATE: MA ZIP: 02139 BUSINESS PHONE: 6173490200 8-K 1 a04-3950_18k.htm 8-K

 

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 26, 2004

 

Transkaryotic Therapies, Inc.

(Exact name of registrant as specified in charter)

 

Delaware

 

000-21481

 

04-3027191

(State or other juris-
diction of incorporation

 

(Commission
File Number)

 

(IRS Employer
Identification No.)

 

 

 

 

 

700 Main Street, Cambridge, Massachusetts

 

02139

(Address of principal executive offices)

 

(Zip Code)

 

 

 

Registrant’s telephone number, including area code:  (617) 349-0200

 

 

(Former name or former address, if changed since last report)

 

 



 

Item 5.      Other Events and Required FD Disclosure.

 

On March 26, 2004, Transkaryotic Therapies, Inc. (“TKT”) 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.

 

The full text of the press release issued in connection with the announcement is attached as Exhibit 99.1 to this Current Report on Form 8-K.

 

Item 7.      Financial Statements, Pro Forma Financial Information and Exhibits.

 

(c)                               Exhibits.

 

99.1                        Press Release.

 

2



 

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.

 

 

Date:  March 26, 2004

TRANSKARYOTIC THERAPIES, INC.

 

 

 

By:

/s/ Gregory D. Perry

 

 

 

Gregory D. Perry

 

 

 

Vice President and Chief Financial
Officer

 

3



 

EXHIBIT INDEX

 

Exhibit No.

 

Description

 

 

 

99.1

 

Press release dated March 26, 2004.

 

4


EX-99.1 3 a04-3950_1ex99d1.htm EX-99.1

Exhibit 99.1

 

CONTACTS:

 

 

 

 

 

Justine E. Koenigsberg

 

Daniella M. Lutz

Director, Corporate Communications

 

Corporate Communications Specialist

(617) 349-0271

 

(617) 349-0205

 

FOR IMMEDIATE RELEASE

 

TKT REGAINS EUROPEAN RIGHTS TO DYNEPO

 

Cambridge, MA, March 26, 2004 — Transkaryotic Therapies, Inc. (Nasdaq: TKTX) today announced that Aventis Pharmaceuticals Inc. has returned rights to Dynepo™ (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.

 



 

- more-

 

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 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 ReplagalÔ, 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 DynepoÔ, a Gene-Activated® 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 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® is a registered trademark and Replagal™ is a trademark of Transkaryotic Therapies, Inc. Dynepo™ is a trademark of Aventis.

 


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