-----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, MOn3nGUd1OZQQCs6bImokaCN13ABf2vNMFk1wKB8Ae1ol197Qa5LglNZDKwl3fXA ynBK8kx0sWqUznrcNdHRRQ== 0000912057-02-037866.txt : 20021007 0000912057-02-037866.hdr.sgml : 20021007 20021007124542 ACCESSION NUMBER: 0000912057-02-037866 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20021002 ITEM INFORMATION: Other events FILED AS OF DATE: 20021007 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: 02782965 BUSINESS ADDRESS: STREET 1: 195 ALBANY ST CITY: CAMBRIDGE STATE: MA ZIP: 02139 BUSINESS PHONE: 6173490200 8-K 1 a2090766z8-k.txt 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): OCTOBER 2, 2002 ----------------------- TRANSKARYOTIC THERAPIES, INC. - -------------------------------------------------------------------------------- (Exact Name of Registrant as Specified in its Charter) DELAWARE - -------------------------------------------------------------------------------- (State or Other Jurisdiction of Incorporation) 000-21481 04-3027191 ----------------------------------- ---------------------------------------- (Commission File Number) (IRS Employer Identification No.) 195 ALBANY STREET, CAMBRIDGE, MASSACHUSETTS 02139 - -------------------------------------------------------------------------------- (Address of Principal Executive Offices) (Zip Code) (617) 349-0200 - -------------------------------------------------------------------------------- Registrant's Telephone Number, Including Area Code NOT APPLICABLE - -------------------------------------------------------------------------------- (Former Name or Former Address, if Changed Since Last Report) Item 5. OTHER EVENTS. ------------ On October 2, 2002, Transkaryotic Therapies, Inc. ("TKT") announced that the previously reported postponement of the September 27, 2002 meeting of the United States Food and Drug Administration's (the "FDA") Endocrinologic and Metabolic Drugs Advisory Committee (the "Committee") will likely delay the timing of a decision by the FDA on the approval of the Biologics License Application (the "BLA") for TKT's drug Replagal(TM) (agalsidase alfa) into the first half of 2003. As part of this announcement, TKT noted that, in anticipation of the Committee meeting, the FDA had expressed concerns to TKT with respect to the clinical data submitted by TKT in support of its BLA for Replagal, particularly with respect to pain. As a result, TKT has determined to seek approval of the BLA for Replagal on the basis of its renal and cardiac clinical data and not on the pain clinical data. -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: October 4, 2002 REGISTRANT TRANSKARYOTIC THERAPIES, INC. By: /s/ Daniel E. Geffken ----------------------------------- Daniel E. Geffken Senior Vice President, Finance and Chief Financial Officer -3- -----END PRIVACY-ENHANCED MESSAGE-----