-----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, JbdvQFswfiAgZP8AxvIGxrslN588fRCsdZFTReiqcfvOQ2MFGiHo4eZRUAH6M7hO pvcqgAcyTtHDhnfNIMuZuQ== 0000912057-01-508392.txt : 20010416 0000912057-01-508392.hdr.sgml : 20010416 ACCESSION NUMBER: 0000912057-01-508392 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20010411 ITEM INFORMATION: ITEM INFORMATION: FILED AS OF DATE: 20010412 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: SEC FILE NUMBER: 000-21481 FILM NUMBER: 1601414 BUSINESS ADDRESS: STREET 1: 195 ALBANY ST CITY: CAMBRIDGE STATE: MA ZIP: 02139 BUSINESS PHONE: 6173490200 8-K 1 a2045365z8-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): APRIL 11, 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 April 11, 2001, Transkaryotic Therapies, Inc. ("TKT") announced that the High Court of Justice in London has issued an opinion in a patent infringement suit TKT and Aventis brought against Kirin-Amgen, Inc., involving Dynepo(TM), the companies' Gene-Activated(R) erythropoietin FOR the treatment of anemia. Mr. Justice Neuberger of the English High Court of Justice presided over the case and ruled that one of four claims of European Patent No. 0 148 605 B2 asserted in the case against TKT and Aventis was not infringed on a literal basis but would be infringed when the claim is construed on a purposive basis (essentially under the U.K. version of the U.S. doctrine of equivalents). The other three claims asserted were found to be invalid and even if valid, incapable of infringement. The full text of TKT's press release issued in connection with the foregoing matter is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. 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: April 12, 2001 REGISTRANT TRANSKARYOTIC THERAPIES, INC. By: /s/ DANIEL E. GEFFKEN ----------------------------- Daniel E. Geffken Senior Vice President, Finance and Chief Financial Officer -3- EXHIBIT INDEX EXHIBIT NUMBER DESCRIPTION 99.1 Press Release -4- EX-99.1 2 a2045365zex-99_1.txt EXHIBIT 99.1 EXHIBIT 99.1 PRESS RELEASE CONTACT: Justine E. Koenigsberg Director, Corporate Communications (617) 349-0271 FOR IMMEDIATE RELEASE HIGH COURT OF JUSTICE ISSUES RULING IN ERYTHROPOIETIN PATENT LITIGATION CAMBRIDGE, MA, APRIL 11, 2001 -- Transkaryotic Therapies, Inc. (Nasdaq: TKTX) today announced the High Court of Justice in London has issued an opinion in a patent infringement suit TKT and Aventis brought against Kirin-Amgen, Inc., involving Dynepo(TM), the companies' Gene-Activated(R) erythropoietin for the treatment of anemia. Mr. Justice Neuberger of the English High Court of Justice presided over the case and ruled that one of four claims of European Patent No. 0 148 605 B2 asserted in the case against TKT and Aventis was not infringed on a literal basis but would be infringed when the claim is construed on a purposive basis (essentially under the U.K. version of the U.S. doctrine of equivalents). The other three claims asserted were found to be invalid and even if valid, incapable of infringement. "We believe we made significant progress in this initial case and are confident we have strong grounds to appeal the remaining issue," said Richard F Selden, M.D., Ph.D., President and Chief Executive Officer of TKT. "The Judge found critical facts in our favor, and we look forward to resolution of this case in mid-2002." Dynepo is a human erythropoietin for the treatment of anemia. Clinical development testing Dynepo as a treatment for anemia of renal failure in dialysis and pre-dialysis patients has been completed, and Aventis is pursuing marketing authorization in the both U.S. and Europe. Transkaryotic Therapies, Inc. (TKT) is a biopharmaceutical company dedicated to the development and commercialization of products based on its three proprietary development platforms: Gene-Activated(R) proteins, Niche Protein(TM) products, and Gene Therapy. The Company'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. TKT's Niche Protein product platform is based on protein replacement for the treatment of rare genetic diseases, a group of disorders characterized by the absence of certain metabolic enzymes. 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. For this purpose, 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 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, 2000 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 Gene-Activated protein, Niche 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. Gene-Activated(R) is a registered trademark and Niche Protein(TM), 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-----