Keryx Biopharmaceuticals Announces that the SUN-MICRO Phase 3 Clinical Trial Failed...

Keryx Biopharmaceuticals Announces that the SUN-MICRO Phase 3 Clinical Trial
Failed to Meet its Primary Efficacy Endpoint
Company to host a conference call Monday, March 10, 2008 at 8:30am

NEW YORK, March 7 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc.
(Nasdaq: KERX) today announced top-line results from its SUN-MICRO Phase 3
clinical trial of Sulonex (sulodexide) for the treatment of diabetic
nephropathy. The Company announced that this Phase 3 clinical trial failed to
meet the primary objective of the study, which was to increase the proportion
of patients that achieve therapeutic success at 6 months as compared to
placebo over background therapy of maximal doses of ACE-inhibitors or ARBs.
Therapeutic success was defined as (i) conversion from microalbuminuria to
normoalbuminuria, as measured by albumin/creatinine ratio (ACR), with at least
a 25% reduction in ACR relative to baseline ACR, or (ii) a 50% reduction in
ACR relative to baseline ACR. In addition, in reviewing the mean changes in
ACR over time, Sulonex and placebo appeared to be similar.
"We are all very disappointed with the outcome of this Study. While this
represents the end of one chapter for Keryx, it is not the end of Keryx. Drug
development is inherently risky and, accordingly, we have spent the last
several years building what we believe to be a promising product portfolio in
the event our lead drug failed. We plan to re-focus our primary efforts and
resources on rapidly moving Zerenex forward for ESRD patients with
hyperphosphotemia and Perifosine forward for cancer. Our goal is to have
Perifosine in a pivotal program this year and be well into our Zerenex
high-dose Phase 2 trial before the end of the year."
The Company will host a conference call on Monday, March 10, 2008 at
8:30am ET.
In order to participate in the conference call, please call 1-877-852-6578
(U.S.), 1-719-325-4794 (outside the U.S.), call-in ID: KERYX. The audio
recording of the conference call will be available for replay at
www.keryx.com, for a period of 15 days after the call.
ABOUT KERYX BIOPHARMACEUTICALS, INC.
Keryx Biopharmaceuticals is focused on the acquisition, development and
commercialization of medically important, novel pharmaceutical products for
the treatment of life-threatening diseases, including renal disease and
cancer. Keryx is developing Zerenex(TM) (ferric citrate), an oral, iron-based
compound that has the capacity to bind to phosphate and form non-absorbable
complexes. Zerenex is currently in Phase 2 clinical development for the
treatment of hyperphosphatemia (elevated phosphate levels) in patients with
end-stage renal disease, or ESRD. The Company is also developing KRX-0401
(perifosine), a novel, potentially first-in-class, oral anti-cancer agent that
modulates Akt, a protein in the body associated with tumor survival and
growth. KRX-0401 also modulates a number of other key signal transduction
pathways, including the JNK and MAPK pathways, which are pathways associated
with programmed cell death, cell growth, cell differentiation and cell
survival. KRX-0401, which is currently in Phase 2 clinical development for
multiple tumor types, is expected to move into a Phase 3 clinical program in
2008. The Company also has an active in-licensing and acquisition program
designed to identify and acquire additional drug candidates.
Cautionary Statement
As the Company has indicated in its public filings, among other things,
clinical trials have a high risk of failure. A number of companies in the
pharmaceutical industry, including biotechnology companies, have suffered
significant setbacks in advanced clinical trials, even after achieving what
appeared to be promising results in earlier trials.
Furthermore, as indicated in previous filings, interim results of
preclinical or clinical studies do not necessarily predict their final
results, and acceptable results in early studies might not be obtained in
later studies. Drug candidates in the later stages of clinical development
may fail to show the desired safety and efficacy traits despite positive
results in initial clinical testing.
Additionally, as indicated in previous filings, there can be no assurance
that the results from the Sulonex Phase 3 study will track the data from the
pilot Collaborative Study Group Phase 2 study or the DiNAS Phase 2 study.
Results from these earlier Sulonex studies may not be indicative of results
from future clinical trials and the risk remains that the pivotal program for
Sulonex may generate efficacy data that will be insufficient for the approval
of the drug, or may raise safety concerns that may prevent approval of the
drug.
Some of the statements included in this press release anticipating future
clinical and business prospects for our lead drug candidate Sulonex, may be
forward-looking statements that involve a number of risks and uncertainties.
For those statements, we claim the protection of the safe harbor for forward-
looking statements contained in the Private Securities Litigation Reform Act
of 1995. Among the factors that could cause our actual results to differ
materially are the following: if, upon final analysis, it is determined that
all trials of Sulonex should be terminated, our ability to successfully adjust
our strategy and reduce our operating expenses in order to properly support
the trials of our other drug candidates; if, upon final analysis of the Phase
3 data, it is determined that dosing should continue in the Phase 4 study, our
ability to complete enrollment into the Phase 4 study on the timetable
previously set for completion of Phase 4; our ability to complete cost-
effective clinical trials or meet anticipated development timelines for the
other drug candidates in our pipeline, including Zerenex and KRX-0401; or
other risk factors identified from time to time in our reports filed with the
Securities and Exchange Commission. Any forward-looking statements set forth
in this press release speak only as of the date of this press release. We do
not intend to update any of these forward-looking statements to reflect events
or circumstances that occur after the date hereof. This press release and
prior releases are available at www.keryx.com. The information in our
website is not incorporated by reference into this press release and is
included as an inactive textual reference only.
KERYX CONTACT:
Lauren Fischer
Director - Investor Relations
Keryx Biopharmaceuticals, Inc.
Tel: 212.531.5965
E-mail: lfischer@keryx.com

SOURCE Keryx Biopharmaceuticals, Inc.

Lauren Fischer, Director - Investor Relations, Keryx Biopharmaceuticals, Inc.,
+1-212-531-5965, lfischer@keryx.com