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) October 3, 2001
ENZON, INC.
(Exact name of registrant as specified in its charter)
Delaware 0-12957 22-2372868
(State or other jurisdiction of (Commission (IRS Employer
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
NA
(Former name or former address, if changed since last report
Item 5. Other Events
On October 3, 2001, Enzon, Inc. ("Enzon") reported that Schering-Plough
Corporation ("Schering-Plough") has announced the U.S. launch of combination
therapy using PEG-INTRON(TM) (peginterferon alfa-2b) Powder for Injection and
REBETOL(R) (ribavirin, USP) Capsules for treating chronic hepatitis C.
Schering-Plough said that REBETOL Capsules, approved in July 2001 as a
separately marketed product, currently are being shipped to trade customers and
are expected to be available at pharmacies nationwide in two to three weeks.
REBETOL is packaged in bottles containing either 42, 56, 70 or 84 capsules each.
PEG-INTRON, approved in January 2001, is available nationwide.
PEG-INTRON is a longer-acting 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, which is approved for dosing according to patient body weight,
is the first and only pegylated interferon product approved for marketing in the
United States. PEG-INTRON, recombinant interferon alfa-2b linked to a 12,000
dalton polyethylene glycol (PEG) molecule, is a once-weekly therapy designed to
optimize the balance between antiviral activity and elimination half-life.
REBETOL had been available in the United States only as a component of
REBETRON(TM) Combination Therapy, which contains REBETOL Capsules and INTRON A
Injection in a single package.
REBETOL Capsules are indicated for use only in combination with PEG-INTRON
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, or with INTRON(R) A (interferon alfa-2b, recombinant)
Injection for the treatment of chronic hepatitis C in patients with compensated
liver disease previously untreated with alpha interferon or who have relapsed
followiasng alpha interferon therapy. The safety and efficacy of REBETOL
Capsules with interferons other than PEG-INTRON or INTRON A products have not
been established.
Some 4 million Americans are infected with the hepatitis C virus ("HCV")
and approximately 70 percent of infected patients go on to develop chronic liver
disease, according to the Centers for Disease Control and Prevention (the
"CDC"). Hepatitis C infection
contributes to the deaths of an estimated 8,000 to 10,000 Americans each year
and this toll is expected to triple by the year 2010, according to the CDC. The
CDC has reported that HCV-associated end-stage liver disease is the most
frequent indication for liver transplantation among adults. It is predicted that
direct U.S. medical costs to treat HCV-related disease will exceed $13 billion
for the years 2010 through 2019, according to a study published in the American
Journal of Public Health.
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 the Company's Form 10-K and Form 8-Ks on file
with the SEC, including without limitation, risks in obtaining and maintaining
regulatory approval for indications and expanded indications, 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: October 4, 2001
ENZON, INC.
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(Registrant)
By: /s/ KENNETH J. ZUERBLIS
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Kenneth J. Zuerblis
Vice President, Finance, Chief Financial
Officer and Corporate Secretary