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 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
Enzon, Inc. reported that Schering-Plough Corporation has advised it that
Schering-Plough has submitted a supplemental Biologics License Application
(sBLA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval
for PEG-INTRON(TM) (peginterferon alfa-2b) Redipen(TM) Single-dose Delivery
System. 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.
Schering-Plough has reported that PEG-INTRON Redipen Single-dose Delivery
System consists of a dual-chamber glass cartridge with a sterile active chamber
containing PEG-INTRON powder and a diluent chamber containing Sterile Water for
Injection, USP. The cartridge is provided in a pen device for reconstitution,
dose preparation and subcutaneous administration. Following reconstitution of
the powder with the diluent contained within the cartridge, each Redipen
Single-dose Delivery System contains PEG-INTRON at strengths of either 50
mcg/0.5 mL, 80 mcg/0.5 mL, 120 mcg/0.5 mL or 150 mcg/0.5 mL for a single use.
The FDA on Jan. 19, 2001, granted marketing approval to PEG-INTRON(TM)
(peginterferon alfa-2b) Powder for Injection 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.
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On June 22, 2001, Schering-Plough reported, among other things, that the
FDA had issued inspection reports (Form FDA-483s) which cited some continuing
and some additional deficiencies concerning compliance with current Good
Manufacturing Practices. Schering-Plough reported that it cannot predict the
outcome of the issues cited in the inspection reports or the timing of any
resolution.
Near the end of June 2001 we were made aware that certain references in
certain of these inspection reports relate to ribavirin, which is manufactured
in Schering-Plough's facilities. The supplemental BLA and NDA for ribavirin that
Schering-Plough submitted to the FDA in February 2001 and November 2000,
respectively, are currently under active FDA review. The February 2001
supplemental BLA seeks marketing
approval for PEG-INTRON for use in combination therapy with REBETOL Capsules
(ribavirin) for the treatment of adult patients with chronic hepatitis C. The
November 2000 supplemental NDA seeks approval to market REBETOL separately for
use in combination with INTRON A for the treatment of the same indication. Enzon
cannot predict whether Schering-Plough's failure to resolve the deficiencies
cited in these inspection reports could delay or otherwise impact the FDA's
review of these applications.
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 16, 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