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 17, 2003
ENZON PHARMACEUTICALS, 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)
685 Route 202/206, Bridgewater, New Jersey 08807
(Address of principal executive offices) (Zip Code)
(Registrant's telephone number, including area code: (908) 541-8600
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(Former name or former address, if changed since last report)
Item 5. Other Events
On June 17, 2003, Enzon Pharmaceuticals, Inc. announced that the Company
and Fresenius Biotechnology, a division of Fresenius, have signed an agreement
in which Fresenius will license to Enzon exclusive North American rights to
develop and commercialize ATG-Fresenius S, a polyclonal antibody preparation
used for T-lymphocyte suppression in organ transplant patients and currently
marketed by Fresenius in over 60 countries worldwide.
Enzon intends to initiate a Phase III clinical program for this product
subject to, and in accordance with, the U.S. Food and Drug Administration (FDA)
requirements during the first half of calendar year 2004. Under the terms of the
agreement, Enzon will be responsible for the costs related to the North American
clinical development and regulatory approval and Fresenius will be responsible
for the drug supplies and all manufacturing aspects necessary to obtain US
regulatory approval.
For the first indication, Fresenius will provide clinical supplies at no
charge to Enzon. Fresenius will receive two separate milestone payments of $1
million each, the first payment upon FDA approval of an Investigational New Drug
Application and the second at the submission of a Biologics License Application.
Upon the commercialization of the product in North America, Enzon will purchase
the finished product from Fresenius at a specified percentage of net sales.
ATG-Fresenius S is a polyclonal antibody preparation. As opposed to
monoclonal antibodies, the product targets a range of antigens on activated
T-cells and depletes T-cells that otherwise would result in an immunologic
attack on the transplanted organ leading to its rejection. For solid organ
transplantation, ATG Fresenius S has been shown to be very effective, typically
leading to a substantial improvement of graft survival. ATG-Fresenius S more
recently has been administered conveniently as a single high dose just prior to
the surgical procedure. ATG-Fresenius S is approved outside the United States
for the prevention of organ rejection and the treatment of acute rejection
episodes. Moreover, clinical experience with ATG-Fresenius S for conditioning
regimens and prevention of graft versus host disease in bone marrow
transplantation has been described.
Except for the historical information herein, the matters discussed in
this filing 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-Q's
and Form 8-K's on file with the SEC, including without limitation, Enzon's
dependence on Schering-Plough's effective marketing of PEG-INTRON; Enzon's
ability to sustain profitability; risks in obtaining and maintaining regulatory
approval for indications and expanded indications for Enzon's products; market
acceptance of and continuing demand for Enzon's products; timing and results of
clinical trials and the impact of competitive products and pricing, All
information in this press release is as of June 17, 2003, and the Company
undertakes no duty to update this information.
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 17, 2003
By: /s/ Kenneth J. Zuerblis
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Kenneth J. Zuerblis
Vice President, Finance and
Chief Financial Officer