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) June 7, 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 June 11, 2001, Enzon, Inc. ("Enzon") reported that Schering-Plough
Corporation's Phase III study comparing its PEG-INTRON(TM) (peginterferon
alfa-2b) Injection to its INTRON(R) A (interferon alfa-2b) Injection in patients
with newly diagnosed chronic myelogenous leukemia (CML) has been completed. In
this study, PEG-INTRON administered once weekly demonstrated clinical
comparability to INTRON A administered daily, with a comparable safety profile.
Despite demonstrating clinical comparability, the efficacy results for
PEG-INTRON did not meet the protocol-specified statistical criteria for
non-inferiority - the primary endpoint in the study. The major cytogenetic
response rates at month 12 for both products were similar to those previously
reported in the literature for alpha interferon.
Results of this Phase III study have not yet been presented or published,
and, therefore, are not publicly available at this time. Presentations of these
data by study investigators at appropriate medical meetings are anticipated,
followed by the subsequent publication of the study results.
In addition to conducting this Phase III study of PEG-INTRON in CML,
Schering-Plough is working with independent investigators to pursue novel
research initiatives with PEG-INTRON in oncology indications through a
comprehensive Medical Affairs program. This program includes large ongoing
studies with PEG-INTRON in high-risk melanoma, myeloma and non-Hodgkin's
lymphoma, both as monotherapy and in combination with other agents.
PEG-INTRON is currently marketed by Schering-Plough in major world markets
for the treatment of chronic hepatitis C. It is the first and only pegylated
interferon approved for marketing in the world. PEG-INTRON (peginterferon
alfa-2b) is a longer-acting form of Schering-Plough's INTRON A that uses
proprietary PEG technology developed by Enzon, Inc. Under Enzon's licensing
agreement with Schering-Plough, Enzon is entitled to royalties on worldwide
sales of PEG-INTRON.
Peter Tombros resigned as a Director of Enzon as of June 7, 2001. Mr.
Tombros, former President and Chief Executive Officer of Enzon, was recently
replaced as President and Chief Executive Officer by Arthur J. Higgins. Mr.
Higgins officially started as President and Chief Executive Officer on May 31,
2001. Mr. Higgins was also elected to Enzon's Board of Directors as of May 31,
2001.
ADAGEN, our first FDA-approved PEG product, is used to treat patients
afflicted with a type of Severe Combined Immunodeficiency Disease, or SCID, also
known as the Bubble Boy Disease, which is caused by the chronic deficiency of
the adenosine deaminase enzyme. The adenosine deaminase or ADA enzyme in ADAGEN
is obtained from bovine intestine. We purchase this enzyme from the world's only
FDA approved supplier, which, until recently, has obtained it from cattle of
German origin. Bovine spongiform encephalopathy (BSE or mad cow disease) has
been detected in cattle herds in the United Kingdom and more recently, in other
European countries. In November 2000, BSE was identified for the first time in
cattle in Germany. There is evidence of a link between the agent that causes BSE
in cattle and a new variant form of Creutzfeld-Jakob, or nvCJD disease, in
humans. The ADA that has been used in ADAGEN and will be used through early
2002, is derived from bovine intestines harvested prior to November 2000, when
herds were identified in Germany as BSE-free. The BSE agent has not been
detected in the herds from which ADA was derived for ADAGEN and we have no
reason to believe that these herds were infected with that agent. Based upon the
timing of the harvest of the intestines, the use of certain purification steps
taken in the manufacture of ADAGEN, and from our analysis of relevant
information concerning this issue, we consider the risk of product contamination
to be extremely low. However, the lengthy incubation period of BSE, and the
absence of a validated test for the BSE agent in pharmaceutical products, makes
it impossible to be absolutely certain that ADAGEN is free of the agent that
causes nvCJD. To date, cases of nvCJD have been rare in the United Kingdom,
where large numbers of BSE-infected cattle are known to have entered the human
food chain. To date, no cases of nvCJD have been linked to ADAGEN or, to our
knowledge, any other pharmaceutical product, including vaccines manufactured
using bovine derived materials from countries where BSE has been detected.
We have been in discussions with the FDA concerning our continued
distribution of ADAGEN. Given the significant benefit to the patients who take
this product, and the likely significant adverse consequences to these patients
if this product were not available, we have agreed with the FDA to continue to
distribute the product. In order to avoid any potential BSE-related risk from
ADAGEN and to be consistent with recommendations from the FDA, our supplier has
secured a new source of bovine intestines from New Zealand, which has no
confirmed cases of BSE. We are working closely with our supplier to expedite the
delivery of ADA from New Zealand herds, but do not anticipate being able to
supply ADAGEN derived from this source until early in 2002. In the longer term,
we are pursuing development of a recombinant form of human ADA, but a product
based on this technology will not be available for several years, if ever.
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.
Item 7. Exhibits
10.30 Employment Agreement between Enzon, Inc. and Arthur J. Higgins dated
May 9, 2001.
10.31 Amendment dated May 23, 2001 to Employment Agreement between Enzon,
Inc. and Arthur J. Higgins dated May 9, 2001.
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: June 12, 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