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) July 24, 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 July 24, 2001, the Company announced the initiation of patient dosing in
a Phase II clinical trial for PROTHECAN(R) (PEG-camptothecin) in patients with
small-cell lung cancer. This Phase II trial is an open-label study, that will
enroll up to 60 patients and evaluate the anti-tumor activity of PROTHECAN.
The Company expects to initiate additional Phase II trials in non-small
cell lung and other cancers with PROTHECAN as both a single-agent and in
combination with other oncolytic agents.
The pharmacokinetic data from ongoing Phase I clinical trials of PROTHECAN
show that biologically relevant plasma concentrations of free camptothecin are
sustained for up to 168 hours after a single dose of PROTHECAN and anti-tumor
activity has been observed.
PROTHECAN is a PEG-enhanced version of a small molecule called
camptothecin, which is an anti-cancer compound in the class of drugs called
topoisomerase I inhibitors. Camptothecin, which was originally studied at the
National Institutes of Health, is a potent topoisomerase inhibitor. For many
years camptothecin has been known to be a very effective oncolytic agent, but
drug delivery problems have limited its use. Two camptothecin derivatives,
topotecan and irinotecan, have been approved by the FDA for the treatment of
small-cell lung and colorectal cancers, respectively. While these two products
are more soluble than camptothecin, their efficacy rate is relatively limited.
Despite their limitations, these two products together achieved 2000 worldwide
sales of approximately $580 million.
On July 26, 2001, the Company announced that Schering-Plough Corporation
has reported that it has been granted marketing approval from the U.S. Food and
Drug Administration (FDA) for REBETOL (ribavirin, USP) Capsules as a separately
marketed product for use only in combination 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 following alpha interferon therapy. The safety
and efficacy of REBETOL Capsules with interferons other than INTRON A have not
been established.
REBETOL had been previously approved in the United States for this
indication only as a component of REBETRON(TM) Combination Therapy, which
contains REBETOL Capsules and INTRON A Injection in a single package.
Schering-Plough has reported it will continue to market REBETRON Combination
Therapy in the United States.
Schering-Plough expects REBETOL Capsules, available by prescription only,
to be available nationwide sometime this fall.
In February 2001, Schering-Plough submitted a supplemental Biologics
License Application (sBLA) to the FDA seeking marketing approval of PEG-INTRON
for use in combination therapy with REBETOL 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 (peginterferon alfa-2b) 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.
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: July 26, 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