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) March 24, 2003
ENZON PharmaceuticalS, INC.
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(Exact name of registrant as specified in its charter)
Delaware 0-12957 22-2372868
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(State or other jurisdiction of (Commission (IRS Employer
incorporation) File Number) Identification)
685 Route 202/206, Bridgewater, New Jersey 08807
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(Address of principal executive offices) (Zip Code)
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(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
Enzon Pharmaceuticals, Inc. reported today data presented at the annual
scientific meeting, Focus on Fungal Infections (FOFI) 13, held in Maui, Hawaii,
suggesting possible new roles for ABELCET(R) (amphotericin B lipid complex
injection) in the management of invasive fungal infections (IFIs). ABELCET, a
long-standing antifungal therapy is approved for the treatment of invasive
fungal infections in patients who are refractory to, or intolerant of
conventional amphotericin B. ABELCET has now been shown to offer new potential
when given in aerosolized form. New data were also presented confirming the
drug's safety profile and renal tolerability. These data support the important
role ABELCET continues to play in treatment strategies for immunocompromised
patients at risk for IFIs.
Data from a recently completed study at Duke University Medical Center
concluded that ABELCET administered in an aerosolized, or inhaled, form had
fewer side effects than aerosolized conventional amphotericin B (acAmB).
According to John Perfect, MD, a Duke investigator, "The trial results are
encouraging and point toward the potential use of inhaled ABELCET as a new
strategy for antifungal prophylaxis in lung transplant patients. This is another
important step in the evaluation of ABELCET as an aerosol in the management of
high risk patients for fungal infections."
In the Duke study, ABELCET was administered via inhalation at 50 mg/d
for 4 days, then once weekly for up to 7 weeks. Of the patients treated with
aerosolized ABELCET, only 8% were considered failures for pulmonary prophylaxis
in this high risk patient population for fungal infections, and of particular
importance, the group receiving aerosolized ABELCET demonstrated a significantly
lower incidence of adverse events compared to acAmB, suggesting a major
safety/tolerance advantage with the use of aerosolized ABELCET which may
translate into a clinical benefit.
An additional study is under way at Duke University Medical Center to
investigate the safety and tolerability of aerosolized ABELCET in allogeneic
bone marrow transplant patients and this study should be completed in the summer
of 2003. In this study, patients are enrolled to receive inhaled ABELCET and
systemic fluconazole prophylaxis through the first 100 days post-transplant (the
period at which patients are at the highest risk of infection). The
investigation into the safety and efficacy of aerosolized ABELCET represents a
new and creative way to use this lipid formulation of amphotericin B in addition
to the approved intravenous indication.
More at FOFI: resolving nephrotoxicity issues
Also at FOFI, data from a Canadian study conducted primarily in cancer
patients at Hamilton Health Sciences, Hamilton, Ontario, demonstrated no
significant difference between ABELCET and Ambisome(R) (liposomal amphotericin
B, Fujisawa Healthcare/Gilead Sciences, Inc.) in the incidence and severity of
nephrotoxicity, or decreased kidney function. This multicenter, retrospective,
and prospective study involved over 250 patients. According to one of the
authors, Barrie McTaggart, "Our study looked at the nephrotoxic effects of two
lipid formulations in patients receiving drugs used in routine practice. In this
setting, we were unable to demonstrate any significant differences between the
two agents in terms of nephrotoxicity. These data do differ from a recently
published study by Wingard et al. Often patients in clinical trials are not
representative of the types of patients receiving drugs in everyday practice.
This may explain the differences in these findings."
Additional presentations from Duke University by Barbara Alexander, MD
reinforced the renal tolerability of ABELCET assessed over a 3-year period. An
in-depth analysis of the university's experience with the drug in 123 transplant
patients revealed that only 14.6% of these patients (considered at high risk for
developing nephrotoxicity, e.g., poor initial renal function, concomitant
nephrotoxic drugs) developed nephrotoxicity as defined by a doubling of baseline
creatinine. Only 1 of the 123 patients who received ABELCET required
hemodialysis at the end of therapy. "Our experience with ABELCET indicates that
renal complications are generally not significant enough to cause therapy
discontinuations in the vast majority of patients," said Dr. Alexander.
Emerging therapeutic strategies: combination use
Investigators at FOFI presented research and cases of successful
ABELCET use in combination with other new, antifungal agents, based on the
premise that different drug classes attack different fungal targets for
synergistic effect.
Enzon reinforces corporate commitment to infectious disease research
Enzon announced last week at FOFI the initiation of a new award for
outstanding achievement in the field of research in infectious disease, the
Thomas J Walsh Clinical Mycology Award by Enzon Pharmaceuticals. This award will
be presented annually beginning in 2004 to acknowledge the accomplishment,
dedication and commitment of an outstanding, researcher. Enzon believes that
this award reflects its own commitment to assist the infectious disease
community in confronting the most important issues surrounding successful
patient care.
About fungal infections
Invasive fungal infections are life-threatening complications often
affecting already compromised patients such as those suffering from cancer, HIV,
recipients of lung and bone marrow transplants, and others. They can be caused
by dozens of different pathogens that attack the patient's weakened immune
system. Effective treatment is critical and can mean the difference between life
and death, and must often be initiated even in the absence of a specific
diagnosis.
About ABELCET (amphotericin B lipid complex injection)
ABELCET was approved for use by the US Food and Drug Administration
(FDA) in November 1995. It is indicated for the treatment of invasive fungal
infections in patients who are refractory to or intolerant of conventional
amphotericin B therapy. The adverse events most commonly reported with ABELCET
are transient chills and/or fever during infusion of the drug. ABELCET is
contraindicated in patients who have shown hypersensitivity to amphotericin B or
any other component in the formulation. Please see full prescribing information
before using ABELCET or any product mentioned in this press release.
Except for the historical information herein, the matters discussed in
this news release 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, 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, the NPS and Enzon businesses may
not be integrated successfully; costs related to the proposed merger may be
significant and greater than we expect; and the NPS or Enzon stockholders may
fail to approve the proposed merger. All information in this Form 8-K is as
of March 24, 2003, and we undertake no duty to update this information.
Additional information and where to find it
In connection with the proposed NPS/Enzon merger, NPS, Enzon, and
Momentum Merger Corporation (which will be renamed by NPS and Enzon in
connection with the proposed merger) intend to file a joint proxy
statement/prospectus with the Securities and Exchange Commission (the "SEC") in
connection with the proposed merger. INVESTORS AND SECURITY HOLDERS ARE URGED TO
READ THE JOINT PROXY STATEMENT/PROSPECTUS WHEN IT BECOMES AVAILABLE BECAUSE IT
WILL CONTAIN IMPORTANT INFORMATION ABOUT THE TRANSACTION. Investors and security
holders may obtain a free copy of the joint proxy statement/prospectus (when it
is available) and other documents filed by NPS and Enzon with the SEC at the
SEC's web site at www.sec.gov or by contacting NPS at 801-583-4939 and through
NPS' web site at www.npsp.com, or by contacting Enzon at 908-541-8678 and
through Enzon's web site at www.enzon.com.
Enzon and its directors and executive officers may be deemed to be
participants in the solicitation of proxies from the stockholders of Enzon and
NPS in connection with the proposed merger transaction. Information regarding
the special interests of these directors and executive officers in the
transaction described herein will be included in the joint proxy
statement/prospectus described above. Additional information regarding these
directors and executive officers is also included in Enzon's proxy statement for
its 2002 Annual Meeting of Stockholders, which was filed with the SEC on or
about October 28, 2002. This document is available free of charge at the SEC's
web site at www.sec.gov or by contacting Enzon at 908-541-8678.
NPS and its directors and executive officers also may be deemed to be
participants in the solicitation of proxies from the stockholders of NPS and
Enzon in connection with the transaction described herein. Information regarding
the special interests of these directors and executive officers in the proposed
merger transaction will be included in the joint proxy statement/prospectus
described above. Additional information regarding these directors and executive
officers is also included in NPS' proxy statement for its 2002 Annual Meeting of
Stockholders, which was filed with the SEC on or about April 19, 2002. This
document is available free of charge at the SEC's web site at www.sec.gov or by
contacting NPS at 801-583-4939 and through the NPS website at www.npsp.com.
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: March 24, 2002
By: /s/ Kenneth J. Zuerblis
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Kenneth J. Zuerblis
Vice President, Finance and
Chief Financial Office