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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 18, 2000
ENZON, INC.
(Exact name of registrant as specified in its charter)
Delaware 0-12957 22-237286
(State or other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Identification)
20 Kingsbridge Road, Piscataway, New Jersey 08854
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (732) 980- 4500
- --------------------------------------------------------------------------------
(Former name or former address, if changed since last report)
Item 5. Other Events
Enzon, Inc. announced that results from a Phase III clinical trial
comparing the safety and efficacy of PEG-INTRON(TM) (peginterferon alfa-2b)
Injection and INTRON(R) A (interferon alfa-2b, recombinant) Injection, as
monotherapy for the treatment of hepatitis C will be presented by study
investigators at the upcoming European Association for the Study of the Liver
(EASL 2000) annual meeting on May 1, 2000. These results were reported in a
study abstract, posted on http://www.easl.com. In this study, after 48- weeks of
treatment plus a 24-week follow-up period, 25% of the patients treated with a
once weekly dose of ug/kg of PEG-INTRON showed a sustained viral response as
compared to 12% of patients receiving INTRON A three times a week. The trial
also concluded that PEG-INTRON was as safe as INTRON A. Preliminary Phase II
clinical results of PEG-Intron and REBETOL Combination Therapy will also be
presented by study investigators.
Schering-Plough Corporation currently markets INTRON A, for hepatitis B and
C and various cancers, and REBETRON(TM), a combination of INTRON A and
REBETOL(R) (ribavirin) capsules, for hepatitis C. Schering-Plough has reported
that the 1999 aggregate worldwide sales of INTRON A/REBETRON were approximately
$1.1 billion.
Monotherapy with PEG-INTRON may provide an alternative treatment to
hepatitis C patients who currently cannot tolerate REBETRON Combination Therapy.
Schering-Plough, in February 2000, announced that the European Union (EU)
Committee for Proprietary Medicinal Products (CPMP) of the European Agency for
the Evaluation of Medicinal Products (EMEA) issued an opinion recommending
approval of PEG-INTRON for hepatitis C. Product approval by the EMEA is
typically issued three months from the time that the Committee renders its
opinion. Approval of this application for PEG-INTRON will allow Schering-Plough
the market PEG-INTRON throughout the European Union. In December 1999,
Schering-Plough submitted a Biologics License Application, or BLA, to the FDA
seeking marketing approval for PEG-INTRON for the treatment of chronic hepatitis
C.
A complete copy of the abstract is available at http://www.easl.com or
http://journals.munksgaard.dk/easl/html/hep717.htm
Certain statements made herein related to potential government approvals,
market potential, commercialization and sales revenues of medical products and
biologics, as well as their therapeutic applications and outcomes, are
forward-looking and are made pursuant to the safe harbor provisions of the
Securities Litigation Reform Act of 1995. Such statements involve risks and
uncertainties, which may differ materially from those set forth in these
statements. In addition, the economic, competitive, governmental, technological
and other factors identified in the Company's filings with the Securities and
Exchange Commission could affect such results.
SIGNATURES
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.
Dated: April 19, 2000
ENZON, INC.
(Registrant)
By: /s/ KENNETH J. ZUERBLIS
-----------------------------------
Kenneth J. Zuerblis
Vice President,
Finance and Chief Financial Officer