SecProbe.io

<DOCUMENT>
<TYPE>CORRESP
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
<PAGE>
                                 ALSTON&BIRD LLP

                                 90 Park Avenue
                            New York, New York 10016

                                  212-210-9400
                                Fax: 212-210-9444
                                 www.alston.com

MARK F. MCELREATH     DIRECT DIAL: 212-210-9595    E-MAIL: MMCELREATH@ALSTON.COM

                                December 2, 2005

VIA: UPS AND EDGAR

Mr. Jim B. Rosenberg
Senior Assistant Chief Accountant
United States Securities and Exchange Commission
100 F Street, N.E.
Division of Corporation Finance
Mail Stop 6010
Washington, D.C. 20549

     Re: Keryx Biopharmaceuticals, Inc.
         Annual Report on Form 10-K for the year ended December 31, 2004
         File No. 000-30929

Dear Mr. Rosenberg:

     At the request and on behalf of our client, Keryx Biopharmaceuticals, Inc.
(the "Company"), we hereby file, via EDGAR, responses to the comments of the
Securities and Exchange Commission (the "Commission") received by telephone from
Oscar M. Young, Jr. ((202) 551-3622), on October 25, 2005, relating to the
Company's Annual Report on Form 10-K for the year ended December 31, 2004 (File
No. 000-30929) (the "Form 10-K"). These responses have been prepared by the
Company with the assistance of its legal counsel. A copy of this letter is also
being sent to the Commission via overnight mail.

COMMENT:

     As was requested in our July 29, 2004, letter, please amend the following
to provide this disclosure as requested by our prior and following comments,
otherwise please explain why an amendment is unnecessary and how you propose to
provide these disclosures in a timely manner.

RESPONSE:

     The Company recognizes the concern of the Commission that any change in
disclosure agreed to in this process will not reach the public until the Company
files its next annual report on Form 10-K in March of 2006. As a result, the
Company proposes to make

<TABLE>
<S>                          <C>                                  <C>                               <C>
    One Atlantic Center             Bank of America Plaza         3201 Beechleaf Court, Suite 600   601 Pennsylvania Avenue, N.W.
1201 West Peachtree Street   101 South Tryon Street, Suite 4000        Raleigh, NC 27604-1062         North Building, 10th Floor
  Atlanta, GA 30309-3424          Charlotte, NC 28280-4000                  919-862-2200              Washington, DC 20004-2601
       404-881-7000                     704-444-1000                     Fax: 919-862-2260                   202-756-3300
     Fax: 404-881-7777                Fax: 704-444-1111                                                   Fax: 202-756-3333
</TABLE>

<PAGE>

Page 2

appropriate changes in our disclosure, as discussed below, in a voluntary filing
on Form 8-K promptly after the Company and the Commission agree on the
appropriate disclosure.

     The Company believes that disclosure on a Form 8-K is more appropriate than
filing an amendment to the Company's Form 10-K for a number of reasons. First,
the Form 10-K already contains substantial disclosure with respect to the types
of information you have requested to be included. With respect to acquired
in-process research and development, the Form 10-K contained a full description
of the assumptions used to determine the amount recorded as acquired in-process
research and development costs associated with the drugs the Company acquired
when it merged with ACCESS Oncology, Inc. in February 2004. With respect to cost
and time estimates of our drug candidates, the Form 10-K contained a full
description of each of our drug candidates, including the status of each drug in
its current stage of development. Additionally, the "Management's Discussion and
Analysis of Financial Condition and Results of Operations" section of the Form
10-K and the same section contained in the Company's quarterly reports on Form
10-Q includes a discussion of the changes in research and development expense,
from period to period, including an approximation of the impact of the
development costs for a particular drug candidate, where applicable. Second, we
believe that the Form 10-K, when it was filed under the Securities Exchange Act
of 1934, as amended (the "Exchange Act"), did not contain any untrue statement
of a material fact or omitted to state a material fact necessary to make the
statements therein, in light of the circumstances under which they were made,
not misleading, and consequently, we believe that the Form 10-K does not need to
be amended. Third, we believe that amending the Form 10-K with the information
you have requested could harm the investing public by confusing them as to
whether the Form 10-K was in fact materially incorrect at the time it was filed.

COMMENT:

     Regarding your response to Part A of our prior comment, please provide
quantitative disclosure about the significant assumptions used in valuing the
acquired in-process research and development.

RESPONSE:

     The Company proposes to make the following disclosure regarding its
acquired in-process research and development charge relating to the ACCESS
Oncology merger in February of 2004. As mentioned above, the Company will
include this disclosure in a voluntary filing on Form 8-K. The Company will also
follow this disclosure format in its future filings with the Commission. For
your convenience, we have marked with double underline and strike-through the
portions of the disclosure which differ from what the Company included in the
Form 10-K.

     Revised Disclosure for the "Critical Accounting Policies" portion of the
     Management's Discussion and Analysis of Financial Condition and Results of
     Operations:

<PAGE>

Page 3

     Accounting Related to the Valuation of Acquired In-Process Research and
     Development.

          As required by Financial Accounting Standards Board Interpretation No.
     4, "Applicability of FASB Statement No. 2 to Business Combinations
     Accounted for by the Purchase Method," or FIN 4, we recorded a charge of
     $18,800,000 for the estimate of the portion of the ACCESS Oncology purchase
     price allocated to acquired in-process research and development.

          A project-by-project valuation using the guidance in Statement of
     Financial Accounting Standards No. 141, "Business Combinations" and the
     AICPA Practice Aid "Assets Acquired in a Business Combination to Be Used In
     Research and Development Activities: A Focus on Software, Electronic
     Devices and Pharmaceutical Industries" was performed with the assistance of
     independent valuation specialists to determine the fair value of research
     and development projects of ACCESS Oncology which were in-process, but not
     yet completed.

          The fair value was determined using the income approach on a
     project-by-project basis. This method starts with a forecast of the
     expected future net cash flows. These cash flows are then adjusted to
     present value by applying an appropriate discount rate that reflects the
     project's stage of completion and other risk factors. These other risk
     factors can include the nature of the product, the scientific data
     associated with the technology, the current patent situation and market
     competition.

          The forecast of future cash flows required the following assumptions
     to be made:

          -    revenue that is likely to result from specific in-process
               research and development projects, including estimated patient
               populations, estimated selling prices, estimated market
               penetration and estimated market share and year-over-year growth
               rates over the product life cycles;

          -    cost of sales related to the potential products using industry
               data or other sources of market data;

          -    sales and marketing expense using industry data or other market
               data;

          -    general and administrative expenses; and

          -    research and development expenses.

          The valuations are based on information that was available as of the
     acquisition date and the expectations and assumptions deemed reasonable by
     our

<PAGE>

Page 4

     management. No assurance can be given, however, that the underlying
     assumptions or events associated with such assets will occur as projected.
     For example, the following changes in our assumptions would have yielded
     the indicated change in the total amount of the in-process research and
     development charge:

          -    If the growth rate regarding the revenue assumptions for the
               three drugs under development and included in the assumptions on
               future cash flows were increased by 10%, the result on the
               aggregate amount of the charge would have been approximately
               $4,500,000, yielding a total charge of approximately $23,300,000,
               or decreased by 5%, the result on the aggregate amount of the
               charge would have been approximately $2,200,000, yielding a total
               charge of approximately $16,600,000;

          -    if the discount rate used to bring the estimated future cash
               flows to a present value amount (which was based on a 55% rate)
               were reduced by 10%, the total charge would have increased to
               approximately $33,000,000, and if the discount rate were
               increased by 10%, the total charge would have decreased to
               approximately $11,000,000.

     Additionally, if it was assumed that the research and development activity
of the least developed of the three drugs under development acquired with ACCESS
Oncology was going to be terminated for any reason, including inconclusive
clinical results, the amount of the in-process research and development charge
may have been reduced, creating a situation were the Company would have
recognized goodwill.

     In each of the above scenarios, the change in the in-process research and
development charge would have required an equal change in contingent equity
rights or if a significant decrease, goodwill would have been recorded.
Contingent equity rights represent the lesser of negative goodwill and the
maximum value of the contingent consideration at the date of the acquisition.
Changes in the in-process research and development charge do not change the
amount or the value of the contingent consideration that could ultimately be
paid.

COMMENT:

     Regarding your response to Part B and C of our prior comment, please
disclose the amount or range of estimated costs and time to complete the current
stage of each project as we had requested. Otherwise, please disclose what
precludes you from making a reasonable and estimated amount of said completion
at the current stage.

RESPONSE:

     The Company proposes to make the following disclosure regarding its
products under development, including certain estimates of costs and time to
complete the development and the risks associated with those estimates. As
mentioned above, the Company will include this disclosure in a voluntary filing
on Form 8-K. The Company will also follow this disclosure format in its future
filings with the Commission. For your convenience, we have marked with double
underline and strike-through the portions of the disclosure which differ from
what the Company included in the Form 10-K.

<PAGE>

Page 5

REVISED DISCLOSURE FOR THE "BUSINESS" PORTION OF THE COMPANY'S ANNUAL REPORT ON
FORM 10-K

PRODUCTS UNDER DEVELOPMENT

KRX-101

Overview

     We have obtained a license to develop sulodexide, or KRX-101, to treat
diabetic nephropathy and other conditions. Diabetic nephropathy is a long-term
complication of diabetes in which the kidneys are progressively damaged.
Sulodexide, our lead drug candidate, is a glycosaminoglycan compound with
structural similarities to the broad family of marketed heparins and low
molecular weight heparins. Specifically, sulodexide is comprised of heparan
sulfate, also referred to as fast-moving heparin, dermatan sulfate and
slow-moving heparin. This drug has been marketed in a number of European, Asian
and South American countries for many years by our licensor for certain
cardiovascular conditions and has a well established safety profile at the doses
used for such indications. Additionally, it has been demonstrated in multiple
clinical trials conducted in Europe, including a randomized, double-blind,
placebo-controlled Phase II study, that KRX-101 can reduce urinary protein
excretion in patients with diabetic nephropathy. In the fourth quarter of 2003,
we announced the initiation of our KRX-101 U.S.-based Phase II/III clinical
program for the treatment of diabetic nephropathy. In the third quarter of 2004,
we completed the target enrollment for the Phase II portion of this clinical
program. This trial is being conducted by the CSG. In January 2005, we announced
that the CSG, based on a safety and efficacy analysis of the interim Phase II
data conducted by an independent DSMC and the CSG, respectively, recommended
that we proceed to the Phase III portion of our Phase II/III clinical program of
KRX-101 for the treatment of diabetic nephropathy, as planned.

     We plan to develop sulodexide in the United States, and possibly other
countries where we have exclusive rights under our license, for the treatment of
diabetic nephropathy and potentially for other indications.

Market Opportunity

     According to the American Diabetes Association, or ADA, there are 18.2
million people in the United States, or approximately 6.3% of the population,
who have diabetes. Of this population, approximately 13 million have been
diagnosed with the disease, of whom approximately 90-95% have been diagnosed
with diabetes mellitus, type 2, referred to as DM2. DM2 results from the
combination of insulin deficiency and the body's relative insensitivity to the
insulin present, as opposed to DM1, in which severe insulin deficiency results
from destruction of the insulin-producing beta cells of the pancreas. Moreover,
an August 2003 study published by Datamonitor estimates that approximately 50%
of all diabetics in the U.S., or approximately 9 million people, have diabetic
nephropathy. Diabetes is the most common cause of End Stage Renal Disease, or

<PAGE>

Page 6

ESRD, in the United States and in many other developed nations and represents
approximately 45% of all new cases of ESRD in the United States. Despite
advances in clinical care, including improvements in glycemic or blood sugar
control and blood pressure control, the number of DM1- and DM2-related cases of
ESRD continues to rise. In particular, the incidence of DM2-related ESRD is
rapidly increasing. Less than 20% of diabetics on dialysis in the United States
survive for five years, making the mortality of end-stage renal failure in this
group higher than most forms of cancer. Unfortunately, renal transplantation is
an option for less than 20% of diabetics with ESRD, as compared to 40-50% of
non-diabetics, principally due to age and concomitant vascular disease. Despite
recent advances, diabetic nephropathy remains a potentially catastrophic
illness, for which partial but insufficient treatment is currently available.

Scientific Background

     Both DM1 and DM2 are characterized by insufficient insulin effect upon
insulin-requiring tissues. As insulin is required for normal metabolism of
glucose, fat and protein, diabetes is accompanied by abnormal blood levels of
these substances. In the short term, hyperglycemia, or elevated blood glucose,
causes the classic symptoms of diabetes: excessive thirst, frequent urination
and weight loss. In the long term, hyperglycemia, as well as other e