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) August 8, 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 August 8, 2001, Enzon, Inc. announced that Schering-Plough (NYSE:SGP)
has reported that the U.S. Food and Drug Administration (FDA) has approved
PEG-INTRON(TM) (peginterferon alfa-2b) Powder for Injection for use in
combination therapy with REBETOL(R) (ribavirin, USP) Capsules 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.
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 the Company's licensing agreement with Schering-Plough, Enzon is entitled
to royalties on worldwide sales of PEG-INTRON.
The PEG-INTRON and REBETOL treatment regimen is the first and only
pegylated interferon-based combination therapy approved in the United States. As
previously reported, REBETOL Capsules are expected to be available nationwide
sometime this fall.
PEG-INTRON was granted marketing approval by FDA on Jan. 19, 2001, as
once-weekly monotherapy for the treatment of chronic hepatitis C in patients not
previously treated with interferon alpha who have compensated liver disease and
are at least 18 years of age. PEG-INTRON, which is approved for dosing according
to patient body weight, is the first and only pegylated interferon monotherapy
approved for marketing in the United States.
REBETOL was granted FDA approval on July 25, 2001, as a separately marketed
product for use only in combination with INTRON A Injection. REBETOL had been
previously approved in the United States only as a component of REBETRON(TM)
Combination Therapy, which contains REBETOL Capsules and INTRON A in a single
package. Schering-Plough continues to market REBETRON Combination Therapy in the
United States.
In the European Union (EU), PEG-INTRON and REBETOL combination therapy was
granted centralized marketing authorization by the European Commission on March
26, 2001, for the treatment of both relapsed and naive (previously untreated)
adult patients with histologically proven chronic hepatitis C.
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. Schering-Plough holds an exclusive
worldwide license to PEG-INTRON.
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 (CDC).
Hepatitis C infection contributes to the deaths of estimated 8,000 to 10,000
Americans each year. This toll is expected to triple by the year 2010 and exceed
the number of annual deaths due to AIDS, 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, Form 10-K/A, Form 10-Q's
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: August 9, 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 Secretary