Keryx Biopharmaceuticals, Inc. Initiates Phase II/III Clinical Program of  
      KRX-101 (Sulodexide Gelcaps) for Treatment of Diabetic Nephropathy 
 
               KRX-101 has FDA Fast-Track Designation To Treat 
                     A Life-Threatening Kidney Condition 
 
 Study to be conducted by the Collaborative Study Group, the world's leading 
         clinical trial group in the field of diabetic kidney disease 
 
    NEW YORK, Oct. 21 -- Keryx Biopharmaceuticals, Inc. [Nasdaq: KERX; London 
AIM: KRX] announced today the initiation of a multi-center clinical trial, 
representing the Phase II portion of its Phase II/III clinical program for the 
treatment of diabetic nephropathy.  This trial is a randomized, double-blind, 
placebo-controlled study, comparing two doses (200mg and 400mg daily) of KRX-
101, the Company's lead drug candidate, versus placebo. 
    The Phase II/III program is designed to assess the safety and efficacy of 
KRX-101 in patients with Type 2 Diabetes who continue to have persistent 
microalbuminuria despite treatment with maximum approved doses of  
standard-of-care therapy (ACE inhibitors or A2 Receptor Blockers (ARBs)).  
This trial will evaluate KRX-101's ability to impact urinary protein (albumin) 
excretion (also referred to as proteinuria) in the study population.  Patients 
will be on treatment for six months, followed by two months of evaluation.  
All patients in the study population will continue to receive maximum approved 
doses of ACEs or ARBs during the treatment and follow-up periods.      
    The entire Phase II/III program is expected to enroll between 
approximately 750 and 1,000 patients, with the Phase II component enrolling up 
to approximately 135 patients.  Enrollment in the Phase II component of the 
program is expected to take six to nine months, with enrollment for the Phase 
III component of the program expected to take an additional twelve to fifteen 
months, depending on the final size of the trial and recruitment rates.  Data 
from the Phase II component of the program is expected to be available as 
early as the fourth quarter of 2004. 
    The KRX-101 Phase II/III clinical program is being conducted by The 
Collaborative Study Group (CSG), the world's largest standing renal clinical 
trial group, whose execution of the ACE Inhibition trial in Type 1 Diabetic 
Nephropathy and the recently completed trial of Irbesartan in Type 2 Diabetic 
Nephropathy (I.D.N.T.) both led to FDA approval and the recommendation of 
these agents as standards of care by the American Diabetes Association.  The 
program's lead investigator is Dr. Edmund J. Lewis, Director of Nephrology at 
the Rush-Presbyterian-St. Luke's Medical Center in Chicago and co-chairman of 
the CSG.  Also participating in the Phase II component are approximately 25 of 
the most highly regarded U.S. clinical centers for the disease.  As the 
program moves into its second component, it is anticipated that a significant 
number of additional clinical centers will participate in the trial. 
    "The commencement of this Phase II/III clinical program marks an extremely 
important milestone in the development of KRX-101, and a significant 
accomplishment for Keryx," commented Michael S. Weiss, Chairman and CEO of 
Keryx.  "Diabetic nephropathy is the leading cause of End-Stage Renal Disease 
(ESRD), a disease that has an approximately 80% 5-year mortality rate and an 
annual cost to the healthcare system in excess of  $15 billion today that is 
expected to grow to nearly $40 billion per year by 2010.  This Phase II/III 
program represents a major step towards bringing this novel treatment closer 
to the three to four million Americans afflicted by the disease and it 
represents the first time KRX-101 will be administered to patients in the U.S.  
The goal of this therapy is to potentially prevent patients afflicted with 
diabetic nephropathy from ever developing ESRD and suffering the hardship of 
its significant associated morbidity and mortality."  
    Dr. Edmund J. Lewis, Co-Chairman of CSG and lead investigator, commented, 
"The CSG is very excited to begin this very important clinical work.  We are 
quite hopeful that this program will corroborate the efficacy KRX-101 has 
demonstrated in its previous European clinical trials in which patients 
treated with KRX-101 experienced highly statistically significant reductions 
in urinary protein levels versus placebo.  If successful, sulodexide will 
offer an entirely new approach in the treatment of this devastating disease." 
    Dr. Lawrence Hunsicker, Co-chairman of the CSG, added, "Despite existing 
therapies, the number of patients progressing to end-stage renal disease 
continues to rise in epidemic proportions.  With such a compelling need for a 
novel treatment approach to diabetic nephropathy, this program represents one 
of the most important developments in treating diabetic nephropathy today.  
The CSG is excited to be able to begin enrolling patients, and looks forward 
to the rapid conclusion of this important clinical program."  
 
    ABOUT KRX-101 
    KRX-101 (sulodexide), a first-in-class oral heparinoid compound, is being 
developed for the treatment of diabetic nephropathy, a progressive and  
life-threatening kidney disease which afflicts approximately 3 to 4 million 
people with diabetes in the United States alone. 
    KRX-101 belongs to a proposed new class of nephroprotective (kidney 
protecting) drugs, called glycosaminoglycans.  A variety of members of this 
chemical family have been shown to decrease pathological albumin excretion in 
diabetic nephropathy in man.  However, these heparin agents all require 
therapy by injection and are all potent anticoagulants, which are blood 
thinners capable of inducing bleeding.  Sulodexide, on the other hand, is 
given orally and, in this form, has demonstrated little, if any, anticoagulant 
effects to date.   
    More than 20 studies have been published in leading medical journals 
assessing the safety and efficacy of KRX-101 in diabetic nephropathy and other 
vascular conditions.  Most recently, KRX-101 demonstrated significant efficacy 
in treating diabetic nephropathy in a randomized, placebo-controlled,  
223-patient Phase II clinical trial (the DiNAS Study) conducted in Europe.  In 
this study, patients with Type 1 and Type 2 diabetes with diabetic nephropathy 
were treated daily for four months with 50, 100- and 200-milligram gel caps of 
KRX-101 and showed substantial dose-dependent reduction in proteinuria, with 
the highest dose achieving a 74% reduction versus placebo following four 
months of treatment.  In addition, the data in the DiNAS Study showed that the 
therapeutic effect of KRX-101 was additive to ACE-inhibitor treatment, 
suggesting that KRX-101 operates under a different mechanism of action than do 
ACE inhibitors and Angiotensin Receptor Blockers ("ARBs"), which represent the 
existing first line of treatment for the disease.  These findings were 
published in the June 2002 issue of the Journal of American Society of 
Nephrology.  
    KRX-101 (sulodexide) has a well-established safety profile based upon 
nearly twenty years of marketing experience by the Company's licensor and use 
by thousands of patients (representing over 50 million patient days of use) in 
Italy, Spain, Eastern Europe, Asia, and South America as a cardiovascular 
drug.   
    In 2001, KRX-101 was granted Fast-Track designation for the treatment of 
diabetic nephropathy and, in 2002, the Company announced that the FDA had 
agreed, in principle, to permit the Company to avail itself of the accelerated 
approval process under subpart H.   
 
    ABOUT DIABETIC NEPHROPATHY 
    According to the American Diabetes Association, there are an estimated  
17 million people with diabetes in the United States, of which 90%-95% are 
people with Type II diabetes.  Approximately 20% of all people with diabetes 
develop diabetic kidney disease, a condition known as diabetic nephropathy. 
Therefore, it is estimated that there are approximately 3 to 4 million people 
suffering from the disease in the U.S. alone.  Diabetes is now the most common 
cause of End Stage Renal Disease, or ESRD, in the U.S. and in many other 
developed nations, and represents 44% of all new cases of ESRD in the U.S. 
Despite advances in clinical care, including improvements in glycemic (blood 
sugar) control and blood pressure control, the number of diabetes-related 
cases of ESRD continues to rise.  In particular, the incidence of Type II 
diabetes-related ESRD is rapidly increasing.  Less than 20% of diabetics on 
dialysis in the US survive for five years, making the mortality of ESRD in 
this group higher than in most forms of cancer.  Principally due to age and 
concomitant vascular disease factors, renal transplantation is an option for 
less than 20% of patients with ESRD from diabetes (as compared to patients 
with ESRD caused by other non-diabetes conditions, for whom 40-50% may benefit 
from renal transplantation).  Thus, despite recent advances, diabetic 
nephropathy remains a potentially catastrophic illness for which partial, but 
insufficient treatment is available today. 
 
    ABOUT KERYX BIOPHARMACEUTICALS, INC. 
    Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX; London AIM: KRX) is a 
biopharmaceutical company focused on the acquisition, development and 
commercialization of novel pharmaceutical products for the treatment of  
life-threatening diseases, including diabetes and cancer.  Keryx is developing 
KRX-101 (sulodexide), a novel first-in-class oral heparinoid compound, for the 
treatment of diabetic nephropathy, for which Keryx is currently conducting its 
U.S.-based Phase II/III clinical program.  Keryx also has an active  
in-licensing program designed to identify and acquire clinical-stage drug 
candidates.  Additionally, Keryx is seeking partners for its KinAce(TM) drug 
discovery technology and related products.  Keryx Biopharmaceuticals is 
headquartered in New York City.  
 
    Some of the statements included in this press release, particularly those 
anticipating future financial performance, timelines for the completion of the 
KRX-101 Phase II/III clinical trial program and the release of data from this 
program, size of the program, market size estimates for KRX-101, growth and 
operating strategies and similar matters, are 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. Important factors may 
cause our actual results to differ materially, including: our ability to 
successfully begin and complete cost-effective clinical trials of KRX-101; and 
other risk factors identified from time to time in our SEC reports, including, 
but not limited to, the report on Form 10-K for the year ended December 31, 
2002, and our quarterly report on Form 10-Q for the quarter ended June 30, 
2003. Any forward-looking statements set forth in this news release speak only 
as of the date of this news 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 Keryx's website is not incorporated by 
reference into this press release and is included as an inactive textual 
reference only.  
 
     KERYX CONTACT: 
     Ron Bentsur 
     VP Finance and Investor Relations 
     Keryx Biopharmaceuticals, Inc. 
     Tel: +1-212-531-5965 
     E-mail: ron@keryx.com 
 
SOURCE  Keryx Biopharmaceuticals, Inc. 
    -0-                             10/21/2003 
    /CONTACT:  Ron Bentsur, VP Finance and Investor Relations of Keryx 
Biopharmaceuticals, Inc., +1-212-531-5965, or ron@keryx.com / 
    /Web site:  http://www.keryx.com / 
    (KERX) 
 
-END-
NNNN



END