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 12, 2002
ENZON, INC.
(Exact name of registrant as specified in its charter)
Delaware 0-12957 22-237286
(State or other jurisdiction (Commission (IRS Employer
of 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
N/A
(Former name or former address, if changed since last report)
Item 5. Other Events
Enzon, Inc. today announced a voluntary recall of the prescription
medication ONCASPAR(R), a product used for the treatment of acute lymphoblastic
leukemia. The lot numbers of ONCASPAR(R)involved in the recall in the U.S. are
AE0114, AE0115, AH0120, AK0129 and AA0201. In addition to the United States
recall, the Company is in the process of notifying its customers of the affected
lots located outside the United States.
During routine testing of ONCASPAR(R) lot number AE0115, and subsequent
testing of other lots, the tested samples were determined to have increased
enzymatic activity in vitro outside the labeled claim. Enzon will be replacing
the recalled lots with product which has been tested and which is currently
within published specifications. The Company is currently reviewing its
inventory and developing an assessment of whether it is adequate to meet current
and anticipated market demand. Enzon cannot provide assurance that sufficient
product will be available to meet demand. Enzon does not currently believe that
the cost of this recall will have a material adverse effect on its fourth
quarter results.
The recall is a voluntary recall initiated by the Company in the United
States but is being conducted with the knowledge of the U.S. Food and Drug
Administration.
Enzon will make arrangements at its own expense with pharmacies in the
United States to have the recalled lots returned to its manufacturing
facilities.
Enzon has provided a dedicated toll-free number to respond to medical
questions from pharmacists, patients and physicians. The toll-free number is
1-800-836-4459.
ONCASPAR is a PEG-enhanced version of a naturally occurring enzyme called
L-asparaginase. It is currently used in conjuction with other chemotherapeutics
to treat patients with acute lymphoblastic leukemia who are hypersensitive, or
allergic, to native, or unmodified, forms of L-asparaginase.
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 including, without limitation, potential adverse regulatory
action, risks that costs of the recall may be more than anticipated, risks that
inventory may be insufficient to satisfy demand, risks in obtaining and
maintaining regulatory approval for indications and expanded indications as well
as manufacturing processes, market acceptance of and continuing demand for
Enzon's products and the impact of competitive products and pricing and other
risks which are described in Enzon's Form 10-K, Form 10-Qs and Form 8-Ks on file
with the SEC.
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, 2002
ENZON, INC.
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(Registrant)
By: /s/Kenneth J. Zuerblis
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Kenneth J. Zuerblis
Vice President,
Finance and Chief Financial Officer
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