Neose Provides Update on IND Review for NE-180
HORSHAM, Pa., July 19 /PRNewswire-FirstCall/ -- Neose Technologies, Inc. (NASDAQ:NTEC) announced that the U.S. Food and Drug Administration (FDA) orally
advised the Company today that it has placed the Company's proposed Phase I
clinical trial for NE-180 on hold. The Company submitted its investigational
new drug application (IND) to the FDA for NE-180 on June 23, 2005. NE-180 is
the Company's long-acting, GlycoPEGylated erythropoietin for the treatment of
chemotherapy-induced anemia. The FDA informed the Company that it requires
additional manufacturing and preclinical information in order to complete its
review of the IND. The Company expects to receive a formal hold letter
detailing the FDA's requests within 30 days.
The Company previously announced that it expected to commence its Phase I
clinical trial for NE-180 in the third quarter of 2005. Due to the FDA's
requests for additional information and depending on the FDA's response to the
information provided, the Company now expects initiation of its Phase I
clinical trial to be delayed by at least one quarter.
"Our highest priority is to respond to the requests of the FDA in an effort to
move our NE-180 program forward with as little delay as possible," said C. Boyd
Clarke, Neose president, chief executive officer and chairman.
Conference Call The Company will host a conference call with the investment community at 8:30
a.m. (EDT) on Wednesday, July 20, 2005 to discuss its announcement regarding
the NE-180 program. The call is expected to last approximately 30 minutes and
will include prepared remarks by Neose management with a subsequent question
and answer period.
The dial-in number for domestic callers is 800-967-7187. The dial-in number for
international callers is 719-457-2635. A replay of the call will be available
for 7 days beginning approximately four hours after the call's conclusion. The
replay number for domestic callers is 888-203-1112, using passcode 5454139. The
replay number for international callers is 719-457-0820, also using passcode
5454139. Live audio of the conference call will be simultaneously broadcast
over the Internet through First call events via the following link: (Please copy and paste link into your server)
http://phx.corporate-ir.net/phoenix.zhtml?p=irol-
eventDetails&c=60494&eventID=1104979 To listen to the live call, please go to the web site at least fifteen minutes
early to register, download, and install any necessary audio software. For
those who cannot listen to the live broadcast, a replay will be available
shortly after the call. The call will also be archived on the Neose website at
http://www.neose.com/.
About Neose Technologies, Inc.
Neose is a biopharmaceutical company using its proprietary enzymatic
technologies to develop improved drugs, focusing primarily on therapeutic
proteins. Neose uses its GlycoAdvance(R) and GlycoPEGylation(TM) technologies
to develop improved versions of drugs with proven safety and efficacy. Neose
intends to apply its technologies to products it is developing on its own and
to products it co-develops and co-owns with others. It also expects to make
its technologies available, through strategic partnerships, to improve the
products of other parties. Neose's first two proprietary candidates are NE-
180 and GlycoPEG-GCSF, a long-acting version of granulocyte colony stimulating
factor (G-CSF).
CONTACTS:
Neose Technologies, Inc.
A. Brian Davis
Sr. Vice President and Chief Financial Officer
(215) 315-9000 Barbara Krauter
Manager, Investor Relations
(215) 315-9004 For more information, please visit http://www.neose.com/.
Neose "Safe Harbor" Statement under the Private Securities Litigation Reform
Act of 1995: Statements in this press release regarding our business that are
not historical facts are "forward-looking statements" that involve risks and
uncertainties, including without limitation the risk that we will not receive
clearance from the FDA to initiate a Phase I clinical trial. For a discussion
of these risks and uncertainties, any of which could cause our actual results
to differ from those contained in the forward-looking statement, see the
section of Neose's Annual Report on Form 10-K for the year ended December 31,
2004, entitled "Factors Affecting the Company's Prospects" and discussions of
potential risks and uncertainties in Neose's subsequent filings with the SEC. DATASOURCE: Neose Technologies, Inc.
CONTACT: A. Brian Davis, Sr. Vice President and Chief Financial Officer, +1-215-315-9000, Barbara Krauter, Manager, Investor Relations, +1-215-315- 9004, both of Neose Technologies, Inc.
Web site: http://www.neose.com/
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