Keryx Expands Study Program for Lead Compound, KRX-101

    Keryx Biopharmaceuticals Launches SOAR Program to Expand Study of KRX-101 
                                 (Sulodexide) 
 
Investigators Invited to Explore Potential of Novel Compound in Disease States 
                 Characterized by Glycosaminoglycan Depletion 
 
    NEW YORK, Aug. 12 -- Keryx Biopharmaceuticals, Inc. 
(Nasdaq: KERX; London AIM: KRX) announced the initiation of a program to 
expand the scientific and medical communities' knowledge and understanding of 
additional potential clinical applications of KRX-101 (sulodexide), the 
Company's lead compound currently scheduled to begin advanced US-based 
clinical trials for the treatment of diabetic nephropathy.  
    Under the program, called SOAR for Sulodexide Open Access Research, the 
Company is inviting top researchers from around the world to study sulodexide 
in their clinics as well as in their pre-clinical models in order to explore 
the drug's potential ability to positively impact a number of disease states, 
including diabetic nephropathy.   
    "This is a very important initiative for us and we believe the SOAR 
program will complement and support our lead program for KRX-101 in the 
treatment of diabetic nephropathy, for which we are on track to commence our 
Phase II/III clinical program late in 3Q or early 4Q of this year," stated 
Michael S. Weiss, Keryx's Chairman and CEO.  "There is intriguing data 
indicating KRX-101 may have substantial positive impact in other disease 
states, including other glomerulopathies and those diseases characterized by 
glycosaminoglycan depletion. Our SOAR program is designed to create 
collaborations with leading investigators from around the world to help us 
explore these additional potential applications." 
    Interested researchers should contact the Company to learn more about the 
SOAR program. 
 
    About KRX 101 (Sulodexide)  
    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.  Several members of this 
chemical family, all heparin agents, have been shown to decrease pathological 
albumin excretion in diabetic nephropathy in humans.  However, these heparin 
agents all require therapy by injection and are all potent anticoagulants, 
which are blood thinners capable of inducing bleeding.  KRX-101, 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 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 
biopharmaceuticals 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 CONTACTS:                               
     Ron Bentsur                              
     Vice President Finance and Investor Relations                     
     Tel: [phone]                          
     E-mail: [e-mail]            
 
    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, which will be filed with the SEC on or before August 14, 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-                             08/12/2003 
    /CONTACT:  S.O.A.R. Program - Dr. Michael Spero, Medical Director,  
[phone], [e-mail], or Dr. Enrique Poradosu, Corporate 
Development Manager, [phone], [e-mail]; or KERYX - Ron 
Bentsur, Vice President Finance and Investor Relations, [phone], 
[e-mail], all of Keryx Biopharmaceuticals, Inc./ 
    /Web site:  http://www.keryx.com / 
    (KERX) 
 





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