Keryx Biopharmaceuticals, Inc. Announces Collaboration

    Keryx Biopharmaceuticals, Inc. Announces S.O.A.R. (Sulodexide Open Access 
Research) Program Collaboration with National Institutes of Health for KRX-101 
                                        
 Esteemed Researcher from the NIDDK Division of the NIH to explore potential 
        beneficial effects of KRX-101 in non-diabetic kidney disease. 
 
    NEW YORK, Oct. 3 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc. 
announced today that, in connection with its recently announced S.O.A.R. 
(Sulodexide Open Access Research) Program, it has entered into a S.O.A.R. 
collaboration for KRX-101 (sulodexide) with Dr. Jeffrey Kopp, principal 
investigator within the Kidney Disease Section of National Institutes of 
Diabetes and Digestive and Kidney Disease at the National Institutes of Health 
("NIH") in Bethesda, Maryland.  
    Dr. Kopp's proposed pre-clinical research is intended to establish a 
rationale for the use of KRX-101 in focal segmental glomerulosclerosis (FSGS), 
a non-diabetic kidney disease characterized by glomerular scarring, with 
progressive loss of kidney function.  Over time this kidney damage often leads 
to end stage renal disease (ESRD).  
    "This collaboration is yet another example of the scientific community's 
excitement over sulodexide's therapeutic potential in microvascular/glomerular 
disorders. Working with the NIDDK division of the NIH is particularly exciting 
and corroborates our own enthusiasm for the potential of this drug in 
therapeutic areas beyond diabetic nephropathy," stated Michael S. Weiss, the 
Company's Chairman and CEO.  Mr. Weiss continued, "Dr Kopp and his team at the 
NIDDK are world class researchers and we look forward to the results from 
these exciting studies."  
 
    ABOUT FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS) 
    FSGS is a form of non-diabetic kidney disease that causes functional and 
anatomical abnormalities of the "filters", or glomeruli, of the kidneys, 
allowing protein to leak into the urine (proteinuria) and causing scarring, 
which, over time, often leads to end stage renal disease (ESRD).   Despite 
current treatment (steroids and other immunosuppressant drugs), many people 
with proteinuric FSGS will progress to complete renal failure requiring 
dialysis (artificial kidney filtration performed by a machine) or kidney 
transplant.  FSGS is a very important cause of kidney disease, being the most 
common cause of complete kidney failure in children and the cause of kidney 
failure in about 5% of adults with kidney failure.  It is the most common 
cause of primary glomerular nephrotic syndrome in adults and is especially 
common in African Americans.  In the U.S. alone, nearly 486,000 people were 
treated for ESRD in 2001, with more than 96,000 new patients treated in that 
year.     
 
    ABOUT THE S.O.A.R. PROGRAM 
    The S.O.A.R. program is designed to expand the knowledge and understanding 
of the potential clinical applications of KRX-101.    
    Pursuant to the S.O.A.R. program, the Company is inviting top researchers 
from around the world to evaluate KRX-101 (sulodexide) in clinical studies as 
well as in pre-clinical models to explore and critically assess the drug's 
potential mechanisms of action and the ability to impact a number of disease 
states, including diabetic nephropathy.  Interested researchers should contact 
the Company to learn more about the S.O.A.R. 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 million 
diabetics 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, Type 1 and Type 2 diabetics with diabetic nephropathy were treated 
daily for 4 months with 50, 100- and 200-milligram gelcaps 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 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 planning 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.  
 
     S.O.A.R. PROGRAM CONTACTS:                              
     Dr. Michael Spero             Dr. Enrique Poradosu                
     Medical Director              Corporate Development Manager  
     Tel: [phone]          Tel: [phone]           
     E-mail: [e-mail] E-mail: [e-mail]  
 
     KERYX CONTACT:                           
     Ron Bentsur 
     VP Finance and Investor Relations 
     Tel: [phone]         
     E-mail: [e-mail]            
  
    Cautionary statement 
    Some of the statements included in this press release, particularly those 
anticipating future financial performance, business prospects, 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: the success of the 
S.O.A.R. program and its ability to develop uses for KRX-101 that can impact a 
number of disease states beyond diabetic nephropathy; 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.  
 
SOURCE  Keryx Biopharmaceuticals, Inc. 
    -0-                             10/03/2003 
    /CONTACT:  Dr. Michael Spero, Medical Director, [phone], 
[e-mail], or Dr. Enrique Poradosu, Corporate Development Manager,  
[phone], [e-mail], both for S.O.A.R. Program; or Ron Bentsur, 
VP Finance and Investor Relations of Keryx, [phone], [e-mail]/ 
    /Web site:  http://www.keryx.com / 
    (KERX) 
 




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