23.04.2008 13:35:00
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Cimzia(R), Utilizing Enzon's Pegylation Technology, Approved in the U.S.
Enzon Pharmaceuticals, Inc. (Nasdaq: ENZN) today announced that the U.S.
Food and Drug Administration (FDA) has approved Cimzia®,
the first and only PEGylated anti-TNFa (Tumor Necrosis Factor alpha)
antibody indicated for reducing signs and symptoms of Crohn’s
disease and maintaining clinical response in adult patients with
moderate to severe active disease who have an inadequate response to
conventional therapy. Cimzia is currently being developed by UCB.
"Enzon continues to be committed to developing
this important technology,” said Jeffrey H.
Buchalter, Enzon's chairman and chief executive officer. "I
am extremely pleased that our PEGylation has enabled another product
which will benefit patients.”
This technology was designed by Enzon to improve versions of injectable
therapeutics through the chemical attachment of polyethylene glycol or
PEG. Specific advantages of PEG include: increased efficacy, reduced
dosing frequency, reduced toxicity and immunogenicity, increased
stability, and enhanced solubility. Currently, there are several
biologic products that utilize our proprietary PEG platform, two of
which we market, Adagen and Oncaspar, others for which we receive
royalties, PEG-INTRON, Pegasys, and Macugen, as well as other products
currently in development.
About Cimzia® (certolizumab pegol)
Cimzia® is the first and only PEGylated
anti-TNFa (Tumor Necrosis Factor alpha). Cimzia®
has a high affinity for human TNF-alpha, selectively neutralizing the
pathophysiological effects of TNF- alpha. Over the past decade,
TNF-alpha has emerged as a major target of basic research and clinical
investigation. This cytokine plays a key role in mediating pathological
inflammation, and excess TNF-alpha production has been directly
implicated in a wide variety of diseases. UCB is developing Cimzia®
in Crohn's Disease, RA and other autoimmune disease indications. For
additional information, including safety information, please refer to
the Cimzia® factsheet in the "News" section
of UCB's website (www.ucb-group.com).
About Enzon
Enzon Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to
the development, manufacturing, commercialization of important medicines
for patients with cancer and other life-threatening conditions. Enzon
has a portfolio of four marketed products, Oncaspar®,
DepoCyt®, Abelcet®
and Adagen®. The Company's drug development
programs utilize several cutting-edge approaches, including its
industry-leading PEGylation technology platform used to create product
candidates with benefits such as reduced dosing frequency and less
toxicity. 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 the Company's 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 period ended December 31, 2007. 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.
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Enzon Pharmaceuticals Inc. | 0,08 | 10,96% |
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NASDAQ Comp. | 19 904,68 | 0,01% |