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 13, 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 ANNOUNCES SCHERING-PLOUGH IN-LICENSING AGREEMENT
WITH ROCHE RESOLVING PEGINTERFERON PATENT DISPUTES
Enzon, Inc. announced today that Schering-Plough (NYSE:SGP) has reported
that that it has entered into a licensing agreement with F.Hoffmann-La Roche Ltd
and Hoffmann-La Roche Inc., (Roche) that settles all patent disputes relative to
the two companies' respective peginterferon products. The agreement provides for
each company to manufacture and market worldwide its peginterferon products free
from liability for infringement under the other's existing patent rights.
Under the agreement, Schering-Plough and Roche will seek court dismissal of
all patent litigation in the United States and Europe involving the two
companies' respective peginterferon products. In addition, opposition to Roche's
European peginterferon patent, filed by both Schering-Plough and Enzon, and
currently pending in the European Patent Office, will be withdrawn.
Under terms of the agreement, Schering-Plough and Roche will cross license
to each other all patents applicable to their pegylated alpha interferon
products, PEG-INTRON(TM) (peginterferon alfa-2b) and PEGASYS (peginterferon
alfa-2a), respectively. In addition, each party will license to the other its
patents applicable to peginterferon as combination therapy with ribavirin.
The settlement agreement also includes a Schering-Plough sublicense of
Enzon's branched PEG patents (among others) to Roche. The sublicense of Enzon
patents pertains only to pegylated versions of alpha interferon. Consequently,
Enzon has agreed to dismiss the patent infringement lawsuit it filed in
September 2000 against Roche asserting that PEGASYS infringes Enzon's branched
PEG patents. However, Enzon will continue to prosecute the patent infringement
lawsuit it filed in December 1998, against Shearwater Polymers Inc. for
infringement of Enzon's branched PEG patents based upon Shearwater's making,
using, and selling branched PEG reagents to parties other than Roche solely with
regard to Roche's peginterferon product, PEGASYS.
In a June 1999 amendment to Enzon's PEG-INTRON licensing agreement with
Schering-Plough, Enzon had granted Schering-Plough a non-exclusive worldwide
license, with a limited right to sublicense, under Enzon's branched PEG patents
in exchange for an increased royalty rate on Schering-Plough's sales of
PEG-INTRON. The PEG-INTRON licensing agreement entitles Enzon to royalties on
worldwide sales of PEG-INTRON.
In addition, Schering-Plough will cooperate should Roche wish to acquire a
license from ICN Pharmaceuticals, Inc. (NYSE: ICN) of Costa Mesa, Calif., under
patent rights to oral ribavirin for use in combination with Roche's
peginterferon product. Currently, Schering-Plough has exclusive license rights
under ICN's patents through a previous licensing agreement with ICN.
Financial terms of the agreement are not being disclosed. The agreement is
subject to the courts' dismissal of the relevant lawsuits.
PEG-INTRON is a longer-acting form of INTRON(R) A (interferon alfa-2b,
recombinant) Injection that uses proprietary PEG technology developed by Enzon.
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 granted by
Enzon.
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/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 13, 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