CSG to Conduct KRX-101 Phase II/III Clinical Program

    The Collaborative Study Group to Conduct US-Based Phase II/III Clinical 
  Program for KRX-101 (sulodexide)for the Treatment of Diabetic Nephropathy 
                                        
            Study places KRX-101 in the hands of Clinical Leaders 
                     In the field of Diabetic Nephropathy 
  
    NEW YORK, Aug. 5 -- Keryx Biopharmaceuticals, Inc. 
(Nasdaq: KERX) announced today that the Collaborative Study Group (CSG), the 
largest standing renal clinical trial group comprised of academic and tertiary 
nephrology care centers, will conduct Keryx's US-based Phase II/III clinical 
program for KRX-101 (sulodexide) for the treatment of diabetic nephropathy.  
It is anticipated that the KRX-101 clinical program will commence by the late 
third quarter or early fourth quarter of 2003. 
    KRX-101 is a first-in-class oral heparinoid compound that has been studied 
extensively in Europe and is currently being marketed in select European, 
Asian and South American markets by the Company's licensor for certain 
cardiovascular indications.  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 indications.  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).  This study was published in the June 2002 issue of the Journal of the 
American Society of Nephrology.  
     "We believe this is an important validation of the potential for KRX-
101," said Michael S. Weiss, Keryx's Chairman and CEO.  "The CSG is highly 
selective in the drug candidates that it works with and has an outstanding 
track-record of conducting high quality, medically important clinical trials 
in the field of renal care and diabetic nephropathy.  In fact, each of their 
last 3 major clinical trials led to product approvals, including the recent 
approval of Bristol-Myers Squibb's and Sanofi's drug, irbesartan (Avapro(R)), 
an angiotensin receptor blocker (ARB) for diabetic nephropathy."  Mr. Weiss 
continued, "We are very excited to place our Phase II/III clinical program for 
KRX-101 in the hands of these leading renal care and diabetes specialists so 
that it may finally begin to benefit the millions of patients that continue to 
suffer from this disease."  
    Dr. Edmund J. Lewis, Principal Investigator of CSG commented, "KRX-101 is 
an exciting and promising treatment for diabetic nephropathy.  The positive 
data from the DiNAS Phase II clinical trial is the culmination of over 20 
years of research, which provides consistent pre-clinical and clinical 
evidence for the benefits of this drug in this disease and related conditions.  
Since the mechanism of action appears to be completely independent of the 
angiotensin system, the target of current interventions in this area, this 
compound represents a truly novel approach to treating the disease.  We are 
genuinely excited for our patients about the prospects of this new agent. " 
    Dr. Lawrence Hunsicker, Co-Chairman of CSG added "We are enthusiastic 
about working with Keryx on the development of KRX-101.  Data generated to 
date indicates that KRX-101 may offer significant benefit above and beyond 
that which we are currently able to achieve with ACE inhibitors and ARBs, the 
current first-line of therapy for this disease.  This is extremely important 
since despite these existing therapies, the number of patients progressing to 
end stage renal disease continues to climb at an alarming rate.  We are 
looking forward to commencing this important clinical program as soon as 
possible."   
 
    ABOUT THE COLLABORATIVE STUDY GROUP 
    The Collaborative Study Group (CSG), the largest standing renal clinical 
trials group, is comprised of academic and tertiary care physician-researchers 
interested in collaborative clinical trials investigating new therapeutic 
approaches in the treatment of kidney disease. Since 1979 the CSG has 
conducted multiple large-scale clinical trials resulting in over 40 major 
publications in peer-reviewed journals. The CSG trial of ACE Inhibition in 
Type 1 Diabetic Nephropathy and the recently completed trial of Irbesartan in 
Type 2 Diabetic Nephropathy (I.D.N.T.) led to FDA product registration for new 
indications and the recommendation of these agents as standard of care by the 
American Diabetes Association. The results of each of the CSG's last 3 major 
clinical trials were published in the New England Journal of Medicine. The 
recently completed IDNT multi-national trial in collaboration with Bristol-
Myers Squibb and Sanofi-Synthelabo is the largest trial in renal disease to 
date, consisting of 1,715 patients from 210 investigative sites worldwide.      
 
    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 DIABETIC NEPHROPATHY 
    According to The American Diabetes Association, there are an estimated 16 
million diabetics in the United States, of which 90%-95% are Type II 
diabetics. Approximately 20% of all diabetics develop diabetic kidney disease, 
a condition known as diabetic nephropathy. Therefore, it is estimated that 
there are approximately 3 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 US and in many other developed nations, and represents 44% of 
all new cases of ESRD in the US. 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 end-stage renal failure in this group higher than in most forms 
of cancer. Unfortunately, renal transplantation is an option for less than 20% 
of diabetics with end-stage renal disease (as compared to 40-50% of non-
diabetics), principally due to age and concomitant vascular disease. 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 
biopharmaceuticals company focused on the acquisition, development and 
commercialization of novel pharmaceutical products for the treatment of 
serious, 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.  
Cautionary Statement  
 
    Statements contained or referenced in this news release that are not 
historical facts, including, but not limited to, statements concerning Keryx's 
ability to successfully begin and complete clinical trials of KRX-101, may be 
forward-looking statements, as the term is defined in the Private Litigation 
Reform Act of 1995. In some cases, you can identify forward-looking statements 
by terminology such as "anticipate", "estimate", "expect", "project", "hope", 
"should', "intend", "plan", "believe", "scheduled", will" and other words and 
terms of similar meaning in connection with any discussion of future operating 
or financial performance. Important factors may cause Keryx's actual results 
to differ materially, including: adverse results in its clinical development 
processes; failure to obtain patent protection for its discoveries; commercial 
limitations imposed by patents owned or controlled by third parties; 
difficulties or delays in obtaining regulatory approvals to market products 
resulting from its development efforts; difficulties or delays in obtaining 
clinical or commercial supplies of our product candidates; and the requirement 
for substantial funding to conduct research and development, and to expand 
commercialization activities. Important factors that might cause or contribute 
to such a discrepancy include, but are not limited to, the risks discussed 
under the heading "Risk Factors" in our Annual Report or Form 10-K, which has 
been filed with the Securities and Exchange Commission, as well as other 
filings we periodically make with the Commission. Any forward-looking 
statements set forth in this news release speak only as of the date of this 
news release. Keryx does 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 
     Vice President Finance and Investor Relations      
     Keryx Biopharmaceuticals, Inc.           
     Tel: [phone]           
     E-mail: [e-mail]          
 
SOURCE  Keryx Biopharmaceuticals, Inc. 
    -0-                             08/05/2003 
    /CONTACT:  Ron Bentsur, Vice President Finance and Investor Relations of 
Keryx Biopharmaceuticals, Inc., [phone], [e-mail]/ 
    /Web site:  http://www.keryx.com / 
    (KERX) 
 




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