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 1, 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
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(Former name or former address, if changed since last report)
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Item 5. Other Events
Enzon, Inc. announced that Schering-Plough Corporation today reported at
the 35th Annual Meeting of the European Association for the Study of the Liver
(EASL) results of a Phase II dose ranging study of PEG-INTRON(TM) combined with
Ribavirin. The results were presented by Rafael Esteban Mur, M.D., professor of
medicine, Servei de Medicina Interna-Hepatologia, Hospital Vall d'Hebron,
Barcelona, Spain, at a satellite symposium sponsored by Schering-Plough. The
combination of PEG-INTRON and REBETOL(R) is currently being studied in Phase III
trials to further define its clinical profile.
A total of 72 patients with chronic hepatitis C and compensated liver
disease were enrolled into the Phase II, open-label, randomized, active
controlled study. Patients in this study received either PEG-INTRON (0.35, 0.7
or 1.4 ug/kg) once weekly alone or in combination with daily REBETOL (600, 800
or 1,000-1,200 mg) for 24 weeks, with 24 weeks of follow up. Patients treated
with PEG-INTRON 0.35, 0.7 or 1.4 ug/kg in combination with REBETOL had sustained
virologic responses at 48 weeks of 17%, 53% and 60%, respectively, compared to
0%, 44% and 42% for patients receiving the same doses of PEG-INTRON alone. Fewer
patients in this study than in the PEG-INTRON Phase III monotherapy study were
genotype 1 (44% vs. 70% respectively) and fewer had high viral load (58% vs. 74%
HCV-RNA > 2 million copies/ml). In this study, the tolerance profile of
PEG-INTRON/REBETOL was comparable to the known tolerance profile of INTRON
A/REBETOL.
Schering-Plough also formally presented the Phase III data comparing
PEG-INTRON (peginterferon alfa-2b) Injection to INTRON(R) A (interferon alfa-2b,
recombinant) Injection as monotherapy for the treatment of hepatitis C that was
reported in a study abstract last week.
Schering-Plough on Dec. 23, 1999 submitted a Biologics License Application
(BLA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval
for PEG-INTRON for the treatment of chronic hepatitis C. On Feb, 17, 2000, the
European Union's (EU) Committee for Proprietary Medicinal Products (CPMP) of the
European Agency for the Evaluation of Medicinal Products (EMEA) issued a
positive opinion recommending approval of PEG-INTRON for the treatment of
hepatitis C. The CPMP opinion serves as the basis for European Commission
approval, which would result in one single Marketing Authorization with unified
labeling that would be valid in all 15 EU-Member States.
According to an article published in the New England Journal of Medicine,
approximately 3.9 million people in the U.S. are infected with the hepatitis C
virus. Approximately 2.7 million of these people are characterized as having
chronic hepatitis C infection. We believe that the number of people infected
with the hepatitis C virus in Europe is comparable to that in the U.S.
PEG-INTRON is a longer-acting form of INTRON A that uses proprietary PEG
technology developed by Enzon. Schering-Plough holds an exclusive worldwide
license to PEG-INTRON. Under Enzon's licensing agreement with Schering-Plough,
Enzon is entitled to royalties on worldwide sales of PEG-INTRON and milestone
payments. Enzon will receive an additional $2 million milestone payment upon
approval of PEG-INTRON.
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INTRON A is a recombinant version of naturally occurring alpha interferon,
which has been shown to exert both antiviral and immunomodulatory effects.
Schering-Plough markets INTRON A, the world's largest-selling alpha interferon,
worldwide for 16 major antiviral and anticancer indications.
REBETOL is an oral formulation of ribavirin, a synthetic nucleoside analog
with broad-spectrum antiviral activity.
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.
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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: May 4, 2000
ENZON, INC.
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(Registrant)
By: /s/ KENNETH J. ZUERBLIS
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Kenneth J. Zuerblis
Vice President,
Finance and Chief Financial Officer
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