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PEGINTRON(R) Receives a Recommendation for Approval from FDA Advisory Committee for a New Application in Melanoma
Monday, October 05, 2009 2:44 PM


Oct. 5, 2009 (Business Wire) -- Enzon Pharmaceuticals, Inc. (Nasdaq: ENZN) today announced that the FDA Oncologic Drug Advisory Committee voted in favor of recommending approval of PEGINTRON® as a treatment in addition to surgery in patients with metastatic melanoma. The product is currently being marketed, manufactured and developed by Schering-Plough. PEGINTRON (Peginterferon alfa-2b) is currently indicated for treatment of chronic hepatitis C in patients 18 years of age or older with compensated liver disease and previously untreated with interferon alpha. PEGINTRON is also indicated for use in combination with REBETOL® (ribavirin) for the treatment of chronic hepatitis C in patients 3 years of age and older with compensated liver disease. PEGINTRON is one of several products which utilize Enzon’s PEGylation technology, including CIMZIA®, Macugen®, and Pegasys®.

“We congratulate Schering-Plough for this great achievement. PEGINTRON provides effective treatment to hepatitis C patients and we are pleased Schering-Plough continues to explore its use in additional areas,” said Jeffrey H. Buchalter, Enzon's president and chief executive officer.

About Enzon

Enzon Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to developing, manufacturing and commercializing important medicines for patients with cancer and other life-threatening conditions. The Company has a portfolio of four marketed products, Oncaspar®, DepoCyt®, Abelcet® and Adagen®. Enzon’s drug development programs utilize several cutting-edge approaches, including its industry-leading PEGylation technology platform and the Locked Nucleic Acid (LNA) technology. Enzon’s PEGylation technology was used to develop two of its products, Oncaspar and Adagen, and has created a royalty revenue stream from licensing partnerships for other products developed using the technology. Enzon also engages in contract manufacturing for several pharmaceutical companies to broaden its revenue base. Further information about Enzon and this press release can be found on the Company’s web site at www.enzon.com.

Forward Looking Statements

There are forward-looking statements contained herein, which can be identified by the use of forward-looking terminology such as the words "believes," "expects," "may," "will," "should,” "potential," "anticipates," "plans" or "intends" and similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, events or developments to be materially different from the future results, events or developments indicated in such forward-looking statements. Such factors include, but are not limited to: the timing, success and cost of clinical studies; the ability to obtain regulatory approval of products; market acceptance of, and continuing demand for, Enzon’s products and the impact of competitive products and pricing. A more detailed discussion of these and other factors that could affect results is contained in our filings with the U.S. Securities and Exchange Commission, including our annual report on Form 10-K for the year ended December 31, 2008. These factors should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements. No assurance can be given that the future results covered by the forward-looking statements will be achieved. All information in this press release is as of the date of this press release and Enzon does not intend to update this information.

(Source: iStockAnalyst )


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