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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) May 30, 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
On May 30, 2000, Schering-Plough Corporation announced that the European
Union's Commission of the European Communities has granted marketing
authorization to PEGINTRON(TM) (peginterferon alfa-2b) as a once-weekly
monotherapy for adult patients with chronic hepatitis C. PEGINTRON is a
longer-acting form of Schering-Plough's INTRON(R) A (interferon alfa-2b,
recombinant) Injection, developed using proprietary Enzon PEG-technology
licensed to Schering-Plough.
Commission approval of the centralized application of PEGINTRON results in
a single Marketing Authorization with unified labeling that is immediately valid
in all 15 EU-Member States. The Commission's decision follows the product's
unanimous recommendation for approval in February 2000 by the EU's Committee for
Proprietary Medicinal Products (CPMP) of the European Agency for the Evaluation
of Medicinal Products (EMEA).
PEGINTRON will be introduced upon receiving pricing approvals, where
necessary, from individual EU countries.
PEGINTRON is indicated as monotherapy in case of intolerance or
contraindication to ribavirin for the treatment of adult patients with
histologically proven chronic hepatitis C who have serum markers indicating
virus replication e.g., those patients who have elevated transaminases (elevated
enzyme levels indicating ongoing liver inflammation) without liver
decompensation and who are positive for serum HCV-RNA (hepatitis C viral RNA) or
anti-HCV (antibodies to hepatitis C virus).
The approved labeling in the EU for PEGINTRON indicates that the optimal
treatment for chronic hepatitis C is considered to be the administration of a
combination of interferon alfa-2b with ribavirin. The safety and efficacy of the
combination of PEGINTRON and ribavirin has not yet been documented.
In addition to this European approval, Schering-Plough is conducting
clinical trials for other therapeutic indications and seeking other marketing
approvals for PEG-INTRON. Phase III clinical trials are on-going with PEG-INTRON
in combination therapy with REBETOL(R) (Ribavirin, USP) for hepatitis C. In
addition, PEG-INTRON is in Phase III clinical trials for two cancer indications,
malignant melanoma and chronic myelogenous leukemia, as well as in early stage
trials for various solid tumors. On December 23, 1999 Schering-Plough submitted
a Biologics License Application to the U.S. Food and Drug Administration seeking
marketing approval in the U.S. for PEG-INTRON as a once-weekly monotherapy for
the treatment of chronic hepatitis C.
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 Enzon'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: June 6, 2000
ENZON, INC.
----------------------
(Registrant)
By: /s/ KENNETH J. ZUERBLIS
-----------------------------------
Kenneth J. Zuerblis
Vice President,
Finance and Chief Financial Officer
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