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Enzon Announces FDA Approval of Schering-Plough's Supplemental NDA to Market REBETOL - ribavirin, USP - Capsules Separately for Use in Combination Therapy With INTRON A for Chronic Hepatitis C.


Business & Health Editors

PISCATAWAY, N.J--(BUSINESS WIRE)--July 26, 2001

Enzon, Inc. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
: ENZN) announced today that Schering-Plough Corporation (NYSE NYSE

See: New York Stock Exchange
:SGP SGP Singapore (ISO Country code)
SGP Schering-Plough (stock symbol)
SGP Stability and Growth Pact
SGP Southern Great Plains
SGP Staatkundig Gereformeerde Partij
SGP Speedway Grand Prix
) has reported that it has been granted marketing approval from the U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) for REBETOL(R) (ribavirin ribavirin /ri·ba·vi·rin/ (ri?bah-vi´rin) a broad-spectrum antiviral used in the treatment of severe viral pneumonia caused by respiratory syncytial virus, particularly in high-risk infants; also used in conjunction with interferon , USP USP - unique sales point ) Capsules as a separately marketed product for use only in combination with INTRON(R) A (interferon alfa-2b, recombinant) Injection for the treatment of chronic hepatitis C in patients with compensated liver disease previously untreated with alpha interferon or who have relapsed following alpha interferon therapy.

The safety and efficacy of REBETOL Capsules with interferons other than INTRON A have not been established.

REBETOL had been previously approved in the United States for this indication only as a component of REBETRON(TM) Combination Therapy, which contains REBETOL Capsules and INTRON A Injection in a single package. Schering-Plough has reported it will continue to market REBETRON Combination Therapy in the United States.

Schering-Plough expects REBETOL Capsules, available by prescription only, to be available nationwide sometime this fall.

In February 2001, Schering-Plough submitted a supplemental Biologics License Application (sBLA) to the FDA seeking marketing approval of PEG-INTRON for use in combination therapy with REBETOL for the treatment of chronic hepatitis C in patients not previously treated with interferon alpha who have compensated liver disease and are at least 18 years of age.

PEG-INTRON (peginterferon alfa-2b) is a longer-acting form of INTRON(R) A (interferon alfa-2b, recombinant) Injection that uses proprietary PEG technology developed by Enzon. Under the Company's licensing agreement with Schering-Plough, Enzon is entitled to royalties on worldwide sales of PEG-INTRON.

Enzon is a biopharmaceutical company developing advanced therapeutics for life-threatening diseases through the application of its proprietary drug delivery and targeting technologies, PEG Modification, Pro Drug/Transport technology and Single-Chain Antigen-Binding (SCA(R)) protein technology. Three products are currently marketed which utilize Enzon's technology: PEG-INTRON marketed by Schering-Plough for hepatitis C, ONCASPAR(R) for Acute Lymphoblastic Leukemia acute lymphoblastic leukemia
n. Abbr. ALL
Lymphoblastic leukemia occurring mainly in older adults, characterized by rapid onset and progression of symptoms. Also called acute lymphocytic leukemia.
 (ALL), and ADAGEN(R) a treatment for a form of Severe Combined Immunodeficiency Disease Noun 1. severe combined immunodeficiency disease - a congenital disease affecting T cells that can result from a mutation in any one of several different genes; children with it are susceptible to infectious disease; if untreated it is lethal within the first year or  (SCID SCID severe combined immunodeficiency (disease); see under immunodeficiency.

SCID
abbr.
severe combined immunodeficiency



SCID

severe combined immunodeficiency disease.
), commonly known as the "Bubble Boy Disease." In addition to three approved products, Enzon has several products in various stages of clinical development by itself and with partners, including additional indications for PEG-INTRON with Schering-Plough. A Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the  is being conducted for PEG-INTRON for the treatment of malignant melanoma. Enzon develops and markets products on its own and through strategic alliances, which in addition to Schering-Plough Corporation, include Alexion Pharmaceuticals, Inc., Baxter Healthcare Corporation, Bristol-Myers Squibb Company, Eli Lilly & Company, and Aventis.

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/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.

This release is also available at www.enzon.com
COPYRIGHT 2001 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2001, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Jul 26, 2001
Words:516
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