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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 26, 2000
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TRANSKARYOTIC THERAPIES, INC.
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(Exact Name of Registrant as Specified in its Charter)
DELAWARE
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(State or Other Jurisdiction of Incorporation)
000-21481 04-3027191
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(Commission File Number) (IRS Employer Identification No.)
195 ALBANY STREET, CAMBRIDGE, MASSACHUSETTS 02139
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(Address of Principal Executive Offices) (Zip Code)
(617) 349-0200
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Registrant's Telephone Number, Including Area Code
NOT APPLICABLE
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(Former Name or Former Address, if Changed Since Last Report)
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Item 5. OTHER EVENTS.
On April 26, 2000, the U.S. District Court of Massachusetts (the
"Court") granted Amgen Inc.'s ("Amgen") Motion for Summary Judgment of
literal infringement on Claim 1 of U.S. Patent No 5,955,422 against
Transkaryotic Therapies, Inc. ("TKT" or the "Company") and Aventis Pharma,
the pharmaceutical company of Aventis SA ("Aventis Pharma"). The Court did
not grant Summary Judgment on any of the other claims of the patents involved
in this suit.
In April 1997, Amgen filed a civil action against TKT and Aventis
Pharma, alleging that Gene-Activated(TM) erythropoietin ("GA-EPO(TM)") and
processes for producing GA-EPO infringe Amgen's U.S. Patent Nos. 5,547,933,
5,618,698, and 5,621,080. In September 1999, U.S. Patents Nos. 5,756,349 and
5,955,422 were added to the suit. All five patents are based on the same
November 1984 specifications. The non-jury trial relating to these patents is
scheduled to begin on May 15, 2000.
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
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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 28, 2000 TRANSKARYOTIC THERAPIES, INC.
(Registrant)
By: /s/ Daniel E. Geffken
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Daniel E. Geffken
Vice President and Chief Financial Officer
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EXHIBIT INDEX
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EXHIBIT NUMBER DESCRIPTION
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99.1 Press Release
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EXHIBIT 99.1
CONTACTS:
Justine E. Koenigsberg Lori Kraut
Transkaryotic Therapies, Inc. Aventis Pharma
(617) 349-0271 (908) 231-5752
FOR IMMEDIATE RELEASE
TKT AND AVENTIS PHARMA PROVIDE UPDATE ON
GA-EPO PATENT LITIGATION
CAMBRIDGE, MA AND FRANKFURT, GERMANY, APRIL 26, 2000 -- Transkaryotic Therapies,
Inc. (Nasdaq: TKTX) and Aventis Pharma, the pharmaceutical company of Aventis
S.A, announced today that the U.S. District Court of Massachusetts has granted
Amgen's motion for Summary Judgment of literal infringement on Claim 1 of U.S.
Patent No. 5,955,422. The Court did not grant Summary Judgment on any of the
other claims of the patents involved in this suit.
Aventis Pharma and TKT issued the following joint statement. "We are at a very
early stage in this case. We believe that it is premature to draw any
conclusions as to the final outcome of this case based on today's ruling. There
are major issues concerning infringement, invalidity, and enforceability of the
patents in question to be argued and determined at the trial beginning next
month in the District Court. We believe we have compelling arguments and remain
confident in our legal position."
In April 1997, Amgen filed a civil action against TKT and Aventis Pharma,
alleging that Gene-Activated-TM- erythropoietin ("GA-EPO-TM-") and processes for
producing GA-EPO infringe Amgen's U.S. Patent Nos. 5,547,933, 5,618,698, and
5,621,080. In September 1999, U.S. Patents Nos. 5,756,349 and 5,955,422 were
added to the suit. All five patents are based on the same November 1984
specifications.
Transkaryotic Therapies, Inc. (TKT) is a biopharmaceutical company dedicated to
the development and commercialization of products based on its three proprietary
development
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platforms: Gene-Activated-TM- 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.
Aventis S.A. (NYSE: AVE) is one of the world's leading life science companies,
focused on two core business areas - pharmaceuticals and agriculture. With
global corporate headquarters in Strasbourg, France, Aventis employs around
90,000 people in 120 countries and recorded pro forma sales in 1998 of euro 21
billion (US$ 21.65 billion). Aventis was launched in December 1999 through the
merger of Hoechst AG and Rhone-Poulenc S.A.
Aventis Pharma AG is the pharmaceutical company of Aventis S.A. Aventis Pharma
is dedicated to treating and preventing human disease through the discovery,
development, manufacture and sale of innovative pharmaceutical products aimed at
satisfying unmet medical needs. Aventis Pharma focuses on important therapeutic
areas such as cardiology, oncology, infectious diseases, arthritis, allergies
and respiratory disorders, diabetes and the central nervous system disorders.
Aventis Pharma has its corporate headquarters in Frankfurt, Germany. Aventis
Pharma also encompasses Aventis Pasteur, a world leader in vaccines based in
Lyon, France, and Aventis Behring, a world leader in therapeutic proteins
headquartered in King of Prussia, Pennsylvania, USA.
STATEMENTS IN THIS NEWS RELEASE OTHER THAN HISTORICAL INFORMATION ARE
FORWARD-LOOKING STATEMENTS SUBJECT TO RISKS AND UNCERTAINTIES. ACTUAL RESULTS
COULD DIFFER MATERIALLY DEPENDING ON FACTORS SUCH AS THE AVAILABILITY OF
RESOURCES, THE TIMING AND EFFECTS OF REGULATORY ACTIONS, THE STRENGTHS OF
COMPETITION, THE OUTCOME OF LITIGATION AND THE EFFECTIVENESS OF PATENT
PROTECTION. ADDITIONAL INFORMATION REGARDING RISKS AND UNCERTAINTIES IS SET
FORTH IN DOCUMENTS OF AVENTIS ON FILE WITH THE SECURITIES AND EXCHANGE
COMMISSION, AS WELL AS THE REGISTRATION STATEMENT ON FORM F-4 OF RHONE-POULENC,
S.A. (THE PREVIOUS NAME OF AVENTIS) AND OTHER DOCUMENTS OF RHONE-POULENC, S.A.
AND HOECHST AG ON FILE WITH THE SECURITIES AND EXCHANGE COMMISSION.
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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," "INTENDS," AND SIMILAR EXPRESSIONS ARE
INTENDED TO IDENTIFY FORWARD-LOOKING STATEMENTS. IMPORTANT FACTORS THAT COULD
CAUSE ACTUAL RESULTS TO DIFFER MATERIALLY FROM THE EXPECTATIONS DESCRIBED IN
THESE FORWARD-LOOKING STATEMENTS ARE SET FORTH UNDER THE CAPTION "CERTAIN
FACTORS THAT MAY AFFECT FUTURE RESULTS" IN TKT'S ANNUAL REPORT ON FORM 10-K FOR
THE YEAR ENDED DECEMBER 31, 1999 WHICH IS ON FILE WITH THE SECURITIES AND
EXCHANGE COMMISSION AND INCORPORATED HEREIN BY REFERENCE. THESE IMPORTANT
FACTORS INCLUDE RISKS AS TO WHETHER TKT'S PRODUCTS WILL ADVANCE IN THE CLINICAL
TRIALS PROCESS, THE TIMING OF SUCH CLINICAL TRIALS, WHETHER THE CLINICAL TRIAL
RESULTS WILL WARRANT CONTINUED PRODUCT DEVELOPMENT, AND WHETHER TKT'S PRODUCTS
WILL RECEIVE APPROVAL FROM THE U.S. FOOD AND DRUG ADMINISTRATION OR EQUIVALENT
REGULATORY AGENCIES, AND, IF SUCH PRODUCTS RECEIVE APPROVAL, WHETHER THEY WILL
BE SUCCESSFULLY MARKETED; THE RESULTS OF ANY PATENT LITIGATION IN WHICH TKT IS
INVOLVED OR MAY BECOME INVOLVED; COMPETITION; AND THE COMPANY'S DEPENDENCE ON
COLLABORATORS.
GA-EPO-TM-, GENE-ACTIVATED-TM-, NICHE PROTEIN-TM-, TKT-TM-, AND
TRANSKARYOTIC THERAPY-TM- ARE trademarks of TRANSKARYOTIC THERAPIES,
INC.
PLEASE VISIT OUR WEB SITE AT WWW.TKTX.COM FOR ADDITIONAL INFORMATION
ABOUT TRANSKARYOTIC THERAPIES, INC.
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