Enzon Reports Schering-Plough's PEG-INTRON Accepted by
the FDA For Review
PISCATAWAY, N.J.--(BUSINESS WIRE)--Feb. 10, 2000
Enzon, Inc. (NASDAQ: ENZN) announced today that Schering-Plough
Corporations' (NYSE: SGP) Biologics License Application (BLA) for
PEG-INTRON(TM) has been accepted for standard review by the FDA.
PEG-INTRON is a modified form of Schering-Plough's INTRON(R) A
(interferon alfa-2b) that uses proprietary PEG technology developed
by Enzon. Schering-Plough submitted its BLA to the FDA on Dec. 23,
1999 seeking marketing clearance for PEG-INTRON (peginterferon
alfa-2b) for the treatment of chronic hepatitis C in patients 18
years of age or older with compensated liver disease.
Under the Prescription Drug Users Fee Act, the FDA should act on
Schering-Plough's BLA within 12 months from the date of receipt.
While Schering-Plough had requested priority review status for the
drug, which would have taken six months, the FDA granted a standard
"We have always assumed that PEG-INTRON would receive the
standard twelve month FDA review," said Peter Tombros, Enzon's
president and CEO. Mr. Tombros further stated, "Schering-Plough has
to be commended for the speed at which they have conducted their
clinical trial program."
"The Agency's acceptance of our application for PEG-INTRON moves
us another step forward in the regulatory review of this product,"
said Tom Lauda, Executive Vice President of Schering-Plough
Pharmaceuticals. "We continue to be pleased with the progress of
our PEG-INTRON filings."
In Europe, Schering-Plough has submitted a centralized Marketing
Authorization Application for PEG-INTRON to the European Union's
(EU) European Agency for the Evaluation of Medicinal Products
(EMEA) seeking marketing approval for the same indication. Approval
of the centralized Marketing Authorization Application for
PEG-INTRON would result in unified labeling that would be valid in
all 15 EU-Member States. The application is currently under CPMP
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. Enzon's research
activities are focused primarily in the area of oncology. In
addition to two FDA approved products, Enzon has several products
in various stages of clinical development by itself and with
partners. Enzon develops and markets products on its own and
through its alliance partners, which in addition to Schering-Plough
include Alexion Pharmaceuticals, Baxter Healthcare, Bristol-Myers
Squibb, Eli Lilly, and Rhone-Poulenc Rorer Pharmaceuticals.
Certain statements made in this press release related to
potential government approvals, market potential, commercialization
and sales revenues of medical products and biologics, as well as
their therapeutic applications and outcomes, are forward-looking
and are made pursuant to the safe harbor provisions of the
Securities Litigation Reform Act of 1995. Such statements involve
risks and uncertainties, which may differ materially from those set
forth in these statements. In addition, the economic, competitive,
governmental, technological and other factors identified in the
Company's filings with the Securities and Exchange Commission could
affect such results.
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