Keryx Biopharmaceuticals, Inc. Announces Collaboration

    Keryx Biopharmaceuticals, Inc. Announces S.O.A.R. (Sulodexide Open Access 
       Research) Program Collaboration with the University of Michigan 
 
      Top researcher to explore potential beneficial effects of KRX-101  
                           in cardiovascular injury 
 
    NEW YORK, Nov. 25 -- In connection with its S.O.A.R. (Sulodexide Open Access 
Research) Program, Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX, London AIM: 
KRX) announced today that it has entered into a S.O.A.R. collaboration with the 
University of Michigan on behalf of Dr. Benedict R. Lucchesi, Professor of 
Pharmacology at the University in Ann Arbor.  Pursuant to this collaboration, 
Dr. Lucchesi and his research team will undertake to assess the potential 
benefit of KRX-101 (sulodexide) in the treatment of cardiovascular injury.  KRX-
101, Keryx's lead drug candidate, is currently in a Phase II/III clinical 
program for the treatment of diabetic nephropathy. 
    A person suffering from a heart attack suffers myocardial damage, both 
during the ischemic phase when blood flow to regions of the heart is 
compromised, and during the reperfusion phase when blood flow is restored as a 
result of drug treatment and/or angioplasty.   Dr. Lucchesi's laboratory, 
which has developed preclinical models for analyzing the pathophysiological 
basis for myocardial injury and the pharmacological protection of the ischemic 
heart, intends for this proposed research to evaluate KRX-101's ability to 
modulate inflammatory events associated with myocardial ischemia and 
reperfusion and its potential benefit in treating these conditions.   
    "We are very excited about the commencement of this collaboration since it 
will be the first time we are exploring KRX-101's therapeutic potential in 
myocardial damage, a condition which significantly limits the probability of 
full recovery for the millions of patients who suffer cardiac events and one 
in which inflammation is a key component.  We are hopeful that KRX-101, with 
its potential distinct anti-inflammatory characteristics, will provide 
therapeutic benefit in this disease area," said Michael S. Weiss, the 
Company's Chairman and CEO.  Mr. Weiss continued, "It is an honor to be 
associated with the University of Michigan and Dr. Lucchesi's highly regarded 
laboratory, and we very much look forward to the results from these exciting 
studies."  
    Dr. Lucchesi commented, "Sulodexide, the subject of numerous publications, 
possesses distinct advantages over other heparins and related GAG's, namely 
its oral bioavailability.  As it is known that the GAG class possesses anti-
inflammatory characteristics, we certainly look forward to exploring KRX-101's 
potential beneficial effect in reducing or preventing myocardial injury 
associated with ischemia and reperfusion." 
 
    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 
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 has initiated a 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 business prospects 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 
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 September 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-                             11/25/2003 
    /CONTACT:  For S.O.A.R. Program - Dr. Michael Spero, Medical Director, 
[phone], [e-mail], or Dr. Enrique Poradosu, Corporate 
Development Manager, [phone], [e-mail]; or For Keryx - Ron 
Bentsur, VP Finance and Investor Relations, Tel: [phone],  
E-mail: [e-mail], all of Keryx Biopharmaceuticals, Inc./ 
    /FCMN Contact: [e-mail] / 
    /Web site:  http://www.keryx.com / 
    (KERX) 
 






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