Keryx Expands Study Program for Lead Compound, KRX-101

    Keryx Biopharmaceuticals, Inc. Announces First S.O.A.R. 
     (Sulodexide Open Access Research) Program Collaboration for KRX-101 
 
     Esteemed Researcher to explore impact of KRX-101 on development and 
                progression of Diabetes in Pre-Clinical Models 
 
    NEW YORK, Sept. 17 -- Keryx Biopharmaceuticals, 
Inc. (Nasdaq: KERX; London AIM: KRX) announced today that, in connection with 
its recently announced S.O.A.R. (Sulodexide Open Access Research) Program, it 
has entered into its first S.O.A.R. collaboration with Dr. Hanna Abboud, 
Professor of Medicine and Chief of the Division of Nephrology at the 
University of Texas Health Sciences Center in San Antonio.  
    Dr. Abboud's proposed research is expected to provide further insight into 
how KRX-101 impacts the development and progression of diabetes-related 
nephropathy.   
    "This is a very exciting beginning to our S.O.A.R. program," stated 
Michael S. Weiss, the Company's Chairman and CEO.  "Our ability to rapidly 
convert a concept to collaboration in just a few short weeks, reflects a high 
level of interest in KRX-101 and in our ability as a company to execute our 
research programs.  Dr. Abboud is a world-class clinician and researcher and 
we eagerly await the results of his very exciting research."    
    Dr. Abboud commented, "KRX-101 is a very interesting compound with several 
distinct mechanisms of action of potential relevance in Diabetic Nephropathy. 
Our research will hopefully add to the current body of knowledge on how  
KRX-101 affects the progression of diabetic nephropathy.  Keryx's S.O.A.R. 
program provides an innovative platform for researchers to access KRX-101, and 
this is particularly exciting because KRX-101 has never before been available 
to US investigators."  
 
    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 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 
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 
     VP Finance and Investor Relations 
     Tel: [phone]  
     E-mail: [e-mail] 
 
     Thomas Redington 
     Redington Inc. 
     203 222 7399 
     212 926 1733 
     www.redingtoninc.com 
 
    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-                             09/17/2003 
    /CONTACT:  S.O.A.R. Program - Dr. Michael Spero, Medical Director, 
[e-mail], or Dr. Enrique Poradosu, Corporate Development Manager, 
[e-mail], [phone], or Ron Bentsur, VP Finance and Investor 
Relations, [phone], [e-mail], all of Keryx Biopharmaceuticals, 
Inc.; Thomas Redington, Redington Inc., [phone], [phone], for 
Keryx Biopharmaceuticals, Inc./ 
    /Web site:  http://www.keryx.com / 
    (KERX) 
 
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