-----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, D66U+1xLiJJAyaVdQXfY9vDQwLzoUaCMFTpAe4H/RIOLGwIXhgzQg5PcDMWPw5gt yS3bcaEnIl7qcmxOO2p/8g== 0000912057-01-542905.txt : 20020412 0000912057-01-542905.hdr.sgml : 20020412 ACCESSION NUMBER: 0000912057-01-542905 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20011212 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20011212 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: 1812175 BUSINESS ADDRESS: STREET 1: 195 ALBANY ST CITY: CAMBRIDGE STATE: MA ZIP: 02139 BUSINESS PHONE: 6173490200 8-K 1 a2065849z8-k.txt FORM 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): December 12, 2001 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 December 12, 2001, Transkaryotic Therapies, Inc. (the "Company") issued a press release announcing that the Committee for Proprietary Medicinal Products of the European Agency for the Evaluation of Medicinal Products has issued a positive opinion recommending approval of Dynepo(TM) (epoetin delta). A copy of the press release is attached to this Current Report on Form 8-K as Exhibit 99.1, and is incorporated herein by reference. Item 7. Financial Statements, Pro Forma Financial Information and Exhibits. (c) Exhibits. 99.1 Press Release, dated December 12, 2001. -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: December 12, 2001 REGISTRANT TRANSKARYOTIC THERAPIES, INC. By: /s/ MICHAEL J. ASTRUE ------------------------------ Michael J. Astrue Senior Vice President, Administration and General Counsel -3- EXHIBIT INDEX EXHIBIT NUMBER DESCRIPTION -------------- ----------- 99.1 Press Release, dated December 12, 2001. -4- EX-99.1 3 a2065849zex-99_1.txt EXHIBIT 99.1 Exhibit 99.1 CONTACT: Justine E. Koenigsberg Director, Corporate Communications (617) 349-0271 FOR IMMEDIATE RELEASE TKT AND AVENTIS RECEIVE RECOMMENDATION FOR MARKETING APPROVAL OF DYNEPO(TM) IN EUROPEAN UNION CAMBRIDGE, MA, DECEMBER 12, 2001 -- Transkaryotic Therapies, Inc. (Nasdaq: TKTX) today announced that the Committee for Proprietary Medicinal Products of the European Agency for the Evaluation of Medicinal Products has issued a positive opinion recommending approval of Dynepo(TM) (epoetin delta). Dynepo, which is being developed with Aventis Pharma, is a human erythropoietin for the treatment of anemia associated with renal disease. The CPMP recommendation for approval will be forwarded to the European Commission for final marketing authorization. If approved by the European Commission, Aventis will be responsible for the marketing and distribution of Dynepo in the fifteen countries of the European Union. "We are pleased that our efforts with this clinical program have been recognized. The CPMP's opinion allows us to move closer to making Dynepo available as a treatment option for patients with anemia," said Helen Critchley, Ph.D., Vice President, International Regulatory Affairs. "This recommendation comes as a result of the hard work and cooperation of many people at both TKT and Aventis." TKT and Aventis are currently involved in litigation with both Amgen Inc. and Kirin-Amgen, Inc. in regard to Dynepo. In April 2001, the High Court of Justice in the United Kingdom ruled that one of four claims of a patent asserted by Kirin-Amgen was infringed by TKT and Aventis in a separate patent suit involving Dynepo. TKT and Aventis have filed an appeal in the case. The companies' ability to market Dynepo will be dependent upon the outcome of the appeal proceeding. Erythropoietin is a hormone that stimulates the production of red blood cells and is used primarily as a treatment for anemia associated with kidney disease or cancer chemotherapy. Dynepo is a human erythropoietin product produced using TKT's proprietary gene activation technology. Dynepo has been tested in over 1400 dialysis and pre-dialysis patients as a treatment for anemia of renal failure. A Phase III study is ongoing to test Dynepo for anemia associated with cancer chemotherapy. -- more -- Transkaryotic Therapies, Inc. CPMP Recommends Approval of Dynepo December 12, 2001 Page 2 ABOUT TKT Transkaryotic Therapies, Inc. (TKT) is a biopharmaceutical company dedicated to the development and commercialization of products based on its three proprietary development platforms: Niche Protein(R) products, Gene-Activated(R) proteins, and gene therapy. The Company's Niche Protein product platform is based on protein replacement for the treatment of lysosomal storage disorders, a group of rare genetic diseases characterized by the absence of certain metabolic enzymes. TKT's gene activation technology is a proprietary approach to the large-scale production of therapeutic proteins, which does not require the cloning of genes and their subsequent insertion into non-human cell lines. The Company's gene therapy technology, known as Transkaryotic Therapy(TM), is focused on the commercialization of non-viral, EX VIVO gene therapy products for the long-term treatment of chronic protein deficiency states. THIS PRESS RELEASE CONTAINS FORWARD-LOOKING STATEMENTS THAT INVOLVE A NUMBER OF RISKS AND UNCERTAINTIES. ANY STATEMENTS CONTAINED HEREIN THAT ARE NOT STATEMENTS OF HISTORICAL FACT MAY BE DEEMED TO BE FORWARD-LOOKING STATEMENTS. WITHOUT LIMITING THE FOREGOING, THE WORDS, "BELIEVES," "ANTICIPATES," "PLANS," "EXPECTS," "ESTIMATES," "INTENDS," "SHOULD," "COULD," "WILL," "MAY," AND SIMILAR EXPRESSIONS ARE INTENDED TO IDENTIFY FORWARD-LOOKING STATEMENTS. 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 WHICH ARE SET FORTH UNDER THE CAPTION "RISK FACTORS" IN THE COMPANY'S QUARTERLY REPORT ON FORM 10-Q FOR THE QUARTER ENDED SEPTEMBER 30, 2001 WHICH IS ON FILE WITH THE SECURITIES AND EXCHANGE COMMISSION AND INCORPORATED HEREIN BY REFERENCE. THESE INCLUDE, WITHOUT LIMITATION, THE FOLLOWING: (1) WHETHER ANY OF THE COMPANY'S NICHE PROTEIN, GENE-ACTIVATED PROTEIN, OR GENE THERAPY PRODUCT CANDIDATES WILL ADVANCE IN THE CLINICAL TRIAL PROCESS, (2) WHETHER SUCH CLINICAL TRIALS WILL PROCEED IN A TIMELY MANNER, (3) WHETHER THE CLINICAL TRIAL RESULTS WILL WARRANT CONTINUED PRODUCT DEVELOPMENT, (4) WHETHER THE REQUIRED REGULATORY FILINGS, SUCH AS INVESTIGATIONAL NEW DRUG APPLICATIONS AND BIOLOGICS LICENSE APPLICATIONS, ARE MADE IN A TIMELY MANNER, (5) WHETHER THE COMPANY'S PRODUCTS WILL RECEIVE APPROVAL FROM THE U.S. FOOD AND DRUG ADMINISTRATION OR EQUIVALENT FOREIGN REGULATORY AGENCIES, (6) IF SUCH PRODUCTS RECEIVE APPROVAL, WHETHER THEY WILL BE SUCCESSFULLY DISTRIBUTED AND MARKETED, (7) WHETHER PATENT LITIGATION IN WHICH THE COMPANY IS INVOLVED OR MAY BECOME INVOLVED ARE RESOLVED IN A MANNER ADVERSE TO THE COMPANY, (8) THE EFFECTS OF COMPETITIVE PRODUCTS ON THE COMPANY'S PROPOSED PRODUCTS, AND (9) THE COMPANY'S DEPENDENCE ON THIRD PARTIES, INCLUDING COLLABORATORS, MANUFACTURERS AND DISTRIBUTORS. IN ADDITION, ANY FORWARD-LOOKING STATEMENTS REPRESENT THE COMPANY'S EXPECTATIONS ONLY AS OF THE DATE HEREOF AND SHOULD NOT BE RELIED UPON AS REPRESENTING THE COMPANY'S EXPECTATIONS AS OF ANY SUBSEQUENT DATE. 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), NICHE PROTEIN(R), AND TKT(R) ARE REGISTERED TRADEMARKS AND TKT(TM) AND TRANSKARYOTIC THERAPY(TM) ARE TRADEMARKS OF TRANSKARYOTIC THERAPIES, INC. DYNEPO(TM) IS A TRADEMARK OF AVENTIS PHARMA. PLEASE VISIT OUR WEB SITE AT WWW.TKTX.COM FOR ADDITIONAL INFORMATION ABOUT TRANSKARYOTIC THERAPIES, INC. ### -----END PRIVACY-ENHANCED MESSAGE-----