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Abelcet

Amphotericin B (Fungilin®, Fungizone®, Abelcet®, AmBisome®, Fungisome®, Amphocil®, Amphotec®) is a polyene antimycotic drug, used intravenously in systemic fungal infections. It was originally extracted from Streptomyces nodosus fungi. Currently the drug is available as plain Amphotericin B, as cholesteryl sulfate complex, as lipid complex, and as liposomal formulation. The latter formulations have been developed to improve tolerability for the patient but may show considerable pharmacokinetic characteristics compared to plain Amphotericin B. more...

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Uses

Oral preparations of amphotericin B are used to treat oral thrush; these are virtually nontoxic. The main i.v. use is in systemic fungal infections (e.g. in immunocompromised patients), and in visceral leishmaniasis. Aspergillosis, cryptococcus infections (e.g. meningitis) and candidiasis are treated with amphotericin B. It is also used empirically in febrile immunocompromised patients who do not respond to broad-spectrum antibiotics.

Method of action

As with other polyene antifungals, amphotericin B associates with ergosterol, a membrane chemical of fungi, forming a pore that leads to K⁺ leakage and fungal cell death. Recently, however, researchers found evidence that pore formation is not necessarily linked to cell death (i.e. Angewandte Chemie Int. Ed. Engl. 2004). The actual mechanism of action may be more complex and multi-faceted.

Side effects

Very often a most serious acute reaction after the infusion (1 to 3 hours later) is noted consisting of fever, shaking chills, hypotension, anorexia, nausea, vomiting, headache, dyspnea, and tachypnea. This reaction sometimes subsides with later applications of the drug and may in part be due to histamine liberation. An increase in prostaglandin-synthesis may also play a role. Often the most difficult decision has to be made, whether the fever is disease- or drug-related. In order to decrease the likelihood and severity of the symptoms, initial doses should be low and increased slowly. The liposomal preperation obviously has a lower incidence of the syndrome. Acetaminophen, pethidine, diphenhydramine and/or hydrocortisone have all be used to treat or prevent the syndrome, but the prophylactic use of these drugs should be limited.

Nephrotoxicity (kidney damage) is a major issue and can be severe and/or irreversible. It is much milder when amphotericin B is delivered in liposomes (AmBisome). Electrolyte imbalances (e.g. hypokalema and hypocalcemia) may also occur.

Increased liver enzymes and hepatotoxicity up to acute liver failure, several forms of anemia and other blood dyscrasias (leukopenia, thrombopenia), serious cardiac arrhythmias (including ventricular fibrillation), and cardiac failure have also been reported frequently. Skin reactions, including serious forms, are also possible.

Interactions

Flucytosine : Toxicity of Flucytosine increased and vice versa
Diuretics or Cisplatin : Increased renal toxicity and incrised risk of hypokalema
Corticosterioids : Increased risk of hypokalema
Cytostatic drugs : Increased risk of kidney damage, hypotension and bronchospasms.
Other nephrotoxic drugs : Increased risk of serious renal damage. Monitor patients closely.
Foscarnet, Ganciclovir, Tenofovir, Adefovir : Risk of hematological and renal side-effects of Amphotericin B increased.
Transfusion of Leukocytes : Risk of pulmonal (lung) damage. Space intervalls between the application of Amphotericin B and the transfusion and monitor pulmonal function.

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Enzon Reports First Quarter Results; Strong Sales Momentum For ABELCET And All Other Proprietary Products Marketed by Enzon
From Business Wire, 11/6/03

Business Editors/Health/Medical Writers

BRIDGEWATER, N.J.--(BUSINESS WIRE)--Nov. 6, 2003

Enzon Pharmaceuticals, Inc. (NASDAQ:ENZN) announced today its financial results for the first quarter of fiscal year 2004 ended September 30, 2003. The company's net income per share for the first quarter of fiscal 2004 was $2.8 million or $0.06 cents per diluted share, versus $12.8 million or $0.29 cents per diluted share for the first quarter of fiscal 2003. The decrease in net income was principally due to decreased royalties from Schering-Plough's PEG-INTRON(R) due to the introduction of a competitive product and increased research and development spending related to the advancement of the company's two late stage development candidates. The decrease was also due to increased income tax expense as the company is now required under GAAP to report fully taxed earnings, because the company previously recognized the tax benefits attributable to its approximately $130 million in federal net operating loss carry forwards. These net operating loss carry forwards remain available to offset income tax payments for the next two to three years.

Total revenue in the first quarter of fiscal 2004 was $40.6 million as compared to $25.1 million in the first quarter of fiscal 2003, resulting in a 62 percent increase. This increase was primarily driven by net sales and manufacturing revenue of $16.6 million related to the ABELCET(R) business, which the company acquired in November 2002.

For the three months ended September 30, 2003, combined sales of the company's other three marketed products ADAGEN(R), ONCASPAR(R), and DEPOCYT(R) were $10 million, a 52 percent increase over sales of $6.6 million in the first quarter of fiscal 2003. ADAGEN sales for the first quarter of fiscal 2004 were $4.6 million versus $3.8 million in the first quarter of fiscal 2003, a 21 percent increase. Sales of ONCASPAR for the first quarter of fiscal 2004 were $4.1 million, a 48 percent increase over sales of $2.8 million in the first quarter of fiscal 2003. Fiscal 2004 first quarter sales of DEPOCYT, marketed through Enzon's specialty sales force, were $1.3 million. The company in-licensed the North American rights to DEPOCYT in January 2003.

Total royalties for the first quarter of fiscal 2004 were $13.8 million, a 25 percent decrease from royalties of $18.4 million for the first quarter of fiscal 2003. Total royalties for the quarter were made up principally of royalties from sales of PEG-INTRON marketed by Schering-Plough.

Research and development expenses increased to $6.6 million in the first quarter of fiscal 2004 from $4.1 million in the same quarter of fiscal 2003. The increase was due to the continued advancement of the company's two late stage compounds, PEG-Camptothecin and ATG Fresenius S, as well as progress in the company's early stage programs.

"All components of our business that we control perform at or better than our expectations," said Arthur J. Higgins, Chairman and Chief Executive Officer of Enzon Pharmaceuticals, Inc. "To highlight the progress in our pipeline we will hold our first Investor R&D Day on November 20th."

SG&A expense increased to $11.2 million in the first quarter of fiscal 2004 versus $3.9 million for the first quarter of fiscal 2003 due to the addition of two sales forces that market ABELCET, DEPOCYT AND ONCASPAR.

The management of Enzon will be hosting a conference call today, November 6, 2003 at 5:00 PM EDT. All interested parties can access the live call using the following information:

Domestic Dial-In Number: 800-553-0351

International Dial-In Number: 612-288-0318

Access Code: 702254

Enzon's conference call will also be webcast in a "listen only" mode via the Internet at http://www.vcall.com. Additionally, for those parties unable to listen at the time of Enzon's conference call, a rebroadcast will be available following the call from Thursday, November 6, 2003 at approximately 10:15 pm. This rebroadcast will end on Thursday, November 13, 2003 at midnight. The rebroadcast may be accessed using the following information:

Domestic Dial-In Number: 800-475-6701

International Dial-In Number: 320-365-3844

Access Code 702254

Enzon Pharmaceuticals is a biopharmaceutical company dedicated to the discovery, development and commercialization of therapeutics to treat life-threatening diseases. The company has developed or acquired a number of marketed products, including PEG-INTRON, marketed by Schering-Plough, and ABELCET, which is marketed in North America by Enzon. Enzon's science-focused strategy includes an extensive drug development program that leverages the Company's PEG modification and single-chain antibody (SCA(R)) technologies. Internal research and development efforts are complemented by strategic transactions that provide access to additional products, projects, and technologies. Enzon has several drug candidates in various stages of development, independently and with partners.

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, Enzon's ability to continue to increase ABELCET's share of the antifungal market and to sustain such increased market share and to successfully market its proprietary products; Enzon's dependence on Schering-Plough's effective marketing of PEG-INTRON; Enzon's ability to clinically advance its PEG-Camptothecin and ATG-Fresenius S programs; Enzon's ability to sustain profitability and positive cash flow; 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 November 6, 2003, and the Company undertakes no duty to update this information.

For further information regarding this press release, please go to Enzon's website homepage at http://www.enzon.com and to Enzon's Investor Relations webpage at http://enzon.com/shareholders.html.

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