07.11.2007 12:08:00
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BioGeneriX and Neose Technologies Announce Positive Data from Two Phase I Studies of GlycoPEG-GCSF
BioGeneriX AG, a member of the ratiopharm Group of companies, and Neose
Technologies, Inc. (NasdaqGM:NTEC) today announced positive data from
two Phase I clinical studies of GlycoPEG-GCSF. GlycoPEG-GCSF is being
co-developed by the companies for the treatment of neutropenia
associated with myelosuppressive chemotherapy.
The first Phase I study evaluated a randomized, weight-based, single
ascending dose of GlycoPEG-GCSF compared to Neulasta®
in 53 healthy subjects. Conclusions from this trial are as follows:
Single doses of GlycoPEG-GCSF demonstrated potent stimulation of
neutrophils and mobilization of peripheral blood progenitor cells.
GlycoPEG-GCSF demonstrated an approximately 30% greater absolute
neutrophil count response versus Neulasta.
GlycoPEG-GCSF demonstrated an approximately 60% increased
bioavailability versus Neulasta®.
Single doses of GlycoPEG-GCSF, up to 100 µg/kg,
were generally well-tolerated with no serious adverse events.
Adverse events were comparable to those for Neulasta®
and there were no discontinuations due to adverse events.
There were no antibodies to GlycoPEG-GCSF detected.
The second Phase I study evaluated a 6 mg dose of GlycoPEG-GCSF versus a
6 mg dose of Neulasta® in 36 healthy subjects.
Conclusions from this trial are as follows:
GlycoPEG-GCSF demonstrated potent stimulation of neutrophils and
mobilization of peripheral blood progenitor cells.
GlycoPEG-GCSF demonstrated an approximately 30% greater absolute
neutrophil count response versus Neulasta.
GlycoPEG-GCSF demonstrated an approximately 60% increased
bioavailability versus Neulasta®.
GlycoPEG-GCSF was generally well-tolerated with no serious adverse
events.
Adverse events were comparable to Neulasta, and there were no
discontinuations due to adverse events.
There were no antibodies to GlycoPEG-GCSF detected.
"We are excited by the data generated in these
Phase I trials. We look forward to moving into Phase II in the first
half of 2008,” said Dr. Karl Heinz Emmert,
BioGeneriX chief scientific officer.
"We are encouraged by the emerging product profile for our GlycoPEG-GCSF
candidate. We look forward to determining whether the intriguing
increases in absolute neutrophil count and bioavailability seen in the
Phase I studies will continue to be evident in patients receiving
chemotherapy in Phase II," said George J. Vergis, Ph.D., Neose president
and chief executive officer.” Conference Call
As previously announced, a conference call will be held this morning at
8:00 a.m. (EST) to review the Phase I data in detail. The call is
expected to last approximately 30 minutes and will include prepared
remarks by Neose and BioGeneriX with a subsequent question and answer
period. A slide presentation of the data will be available via the
webcast and can also be accessed immediately on the Neose website via
the following link: http://phx.corporate-ir.net/phoenix.zhtml?c=60494&p=irol-presentations
The dial-in number for domestic callers is (800) 896-8445. The dial-in
number for international callers is (785) 830-1916. A replay of the call
will be available for 7 days beginning approximately three hours after
the conclusion of the call. The replay number for domestic callers is
(888) 203-1112, using the passcode 1841153. The replay number for
international callers is (719) 457-0820, also using the passcode
1841153. The call will also be webcast live through the Company’s
website via the following link: http://phx.corporate-ir.net/phoenix.zhtml?c=60494&p=irol-calendar
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.
About G-CSF and Neutropenia
G-CSF is prescribed to stimulate the production of neutrophils, and is
approved for sale in major markets around the world for the treatment of
neutropenia associated with myelosuppressive chemotherapy. Worldwide
sales in the G-CSF category exceeded $4 billion in 2006. Neutropenia is
a severe reduction in the number of neutrophils (mature white blood
cells) in the circulating blood, commonly associated with cancer
chemotherapy. Patients with neutropenia are at increased risk of
developing serious infection. If not treated promptly, neutropenia can
be life-threatening.
About BioGeneriX AG
BioGeneriX AG was founded in June 2000 to develop biopharmaceutical
drugs with known modes of action and established drug markets. With its
internal resources and a large network of strategic partners and service
providers, BioGeneriX develops a high-quality biotech portfolio for
marketing and distribution by its parent company and global partners.
For more information, visit its website at www.biogenerix.com.
About the ratiopharm Group
ratiopharm is Europe's leading generics producer and in its home country
Germany the top selling and most commonly prescribed pharmaceutical
brand. The company produces high quality medicines and sells them at low
prices. By doing so, it contributes to cost containment in the
healthcare sector. With over 700 medicines, available exclusively from
pharmacies, it has one of the widest product ranges in the business.
ratiopharm sells 472 million pack units every year, meeting the needs of
virtually all areas of medicine, from allergies to circulation problems
and from gastroenteritis to toothaches. Founded in 1974, ratiopharm is
now bringing its business model and experience to international markets.
It is already active in 24 countries. In 2006, ratiopharm generated
worldwide revenues of 1.7 billion Euros, of which 800 million Euros were
from sales in Germany. For more information, visit its website at www.ratiopharm.de.
About Neose Technologies, Inc.
Neose Technologies, Inc. is a clinical-stage biopharmaceutical company
focused on the development of next-generation therapeutic proteins that
are competitive with best-in-class protein drugs currently on the
market, on its own and through strategic partnerships. The lead
candidates in its pipeline, NE-180 for use in the treatment of
chemotherapy-induced anemia and anemia associated with chronic kidney
disease and GlycoPEG-GCSF for chemotherapy-induced neutropenia, target
markets with 2006 aggregate sales in excess of $15 billion. For more
information, please visit 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 GlycoPEG-GCSF
could fail in later clinical trials or never receive regulatory
approval. 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 sections of Neose’s
Annual Report on Form 10-K for the year ended December 31, 2006,
entitled "Risk Factors”
and "Special Note Regarding Forward-Looking
Statements” and discussions of potential
risks and uncertainties in Neose's subsequent filings with the SEC.
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