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) February 16, 2001
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
N/A
(Former name or former address, if changed since last report)
Item 5. Other Events
On February, 16, 2001, Enzon, Inc. announced the following statement
concerning Schering-Plough Corporation's recent announcement on manufacturing
issues as a result of FDA inspections at its New Jersey and Puerto Rico
facilities.
"PEG-INTRON(TM) and INTRON(R) A are manufactured at Schering-Plough's
biotechnology manufacturing facility in County Cork (Brinny), Ireland."
PEG-INTRON(TM) (peginterferon alfa-2b) is a longer acting form of
Schering-Plough's INTRON(R) A (interferon alfa-2b, recombinant) Injection that
uses proprietary PEG technology developed by Enzon. Under the Company's
licensing agreement with Schering-Plough, Enzon is entitled to royalties on
worldwide sales of PEG-INTRON.
On January 19, 2001, the FDA granted marketing approval to PEG-INTRON for
use as once-weekly monotherapy for the treatment of chronic hepatitis C in
patients not previously treated with alpha interferon who have compensated liver
disease and are at least 18 years of age. PEG-INTRON is the first and only
pegylated interferon approved for marketing in the world.
On February 20, 2001, Enzon, Inc. reported that Schering-Plough Corporation
of Kenilworth, N.J., has been issued U.S. patent 6,172,046 claiming a method of
treating patients infected with hepatitis C virus by administering peginterferon
alfa-2b (PEG-INTRON(TM)) and ribavirin (REBETOL(R)) combination therapy.
Corresponding international patents have been filed.
REBETOL is currently approved in the United States for use in combination
with INTRON A Injection for the treatment of chronic hepatitis C in patients
with compensated liver disease previously untreated with alpha interferon or who
have relapsed following alpha interferon therapy. REBETOL is marketed in the
United States as a component of REBETRON(TM) Combination Therapy, which contains
REBETOL Capsules and INTRON A Injection in a single package. On November 7,
2000, Schering-Plough submitted a supplemental New Drug Application (sNDA)
seeking FDA approval to market REBETOL separately for use in combination with
INTRON A. The REBETOL application is currently undergoing FDA review.
Except for the historical information herein, the matters discussed in this
Form 8-K include forward-looking statements that may involve a number of risks
and uncertainties. Actual results may vary significantly based upon a number of
factors which are described in Enzon's Form 10-K, Form 10-Q's and Form 8-K on
file with the SEC, including without limitation, risks in obtaining and
maintaining regulatory approval for Enzon's products and expanded indications
for such products, market acceptance of and continuing demand for Enzon's
products and the impact of competitive products and pricing.
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: February 20, 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