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) January 16, 2002
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
Enzon, Inc. announced today that Schering-Plough Corporation has advised it
of the following:
o Prior to the launch of the combination therapy of PEG-INTRON(TM)
and REBETOL(R) in the United States in October 2001,
Schering-Plough initiated a program called the PEG-INTRON Access
Assurance program. This program was established to ensure that
patients who begin treatment will have uninterrupted access to a
full course of therapy.
o To date, more than 60,000 patients have enrolled in the Access
Assurance program. Schering-Plough believes that there is
adequate supply of PEG-INTRON to meet the needs of all patients
currently on therapy.
o Schering-Plough believes that the Access Assurance program will
soon need to transition to a wait list for newly enrolling
patients in the U.S. Initially, it is expected that patients put
on the wait list would be able to begin treatment in about 10 to
12 weeks from enrolling.
o Schering-Plough believes that there is an adequate supply of
PEG-INTRON to meet current demand in international markets. The
Access Assurance program was implemented for the U.S. only and
there is no similar program for other markets.
PEG-INTRON is a longer-action form of INTRON(R) A (interferon alfa-2b,
recombinant) Injection that uses proprietary PEG technology developed by Enzon.
Under Enzon's licensing agreement with Schering-Plough, Enzon is entitled to
royalties on worldwide sales of PEG-INTRON. Schering-Plough holds an exclusive
worldwide license to PEG-INTRON.
PEG-INTRON and REBETOL combination therapy received U.S. Food and Drug
Administration approval in August 2001 for the treatment of chronic hepatitis C
in patients with compensated liver disease who have not been previously treated
with interferon alpha and are at least 18 years of age. The launch of this
combination therapy in the U.S. was announced in October 2001. The combination
therapy was approved for hepatitis C in the European Union in March 2001.
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-Qs and Form 8-Ks on
file with the SEC, including without limitation, risks in obtaining and
maintaining regulatory approval for indications and expanded indications as well
as manufacturing processes, market acceptance of and continuing demand for
Enzon's products, the effective marketing of PEG-INTRON by Schering-Plough 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: January 16, 2002
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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