SecProbe.io

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Mail Stop 3-9								May 4, 2005

David S. Tierney, M.D.
President and Chief Executive Officer
Valera Pharmaceuticals, Inc.
8 Clarke Drive
Cranbury, NJ 08512

Re:	Valera Pharmaceuticals, Inc.
	Registration Statement on Form S-1
      Amended April 20, 2005
	File Number 333-123288

Dear Dr. Tierney:

      We have reviewed your filing and have the following
comments.
Where indicated, we think you should revise your document in
response
to these comments.  If you disagree, we will consider your
explanation as to why our comment is inapplicable or a revision is
unnecessary.  Please be as detailed as necessary in your
explanation.
In some of our comments, we may ask you to provide us with
supplemental information so we may better understand your
disclosure.
After reviewing this information, we may or may not raise
additional
comments.

      Please understand that the purpose of our review process is
to
assist you in your compliance with the applicable disclosure
requirements and to enhance the overall disclosure in your filing.
We look forward to working with you in these respects.  We welcome
any questions you may have about our comments or on any other
aspect
of our review.  Feel free to call us at the telephone numbers
listed
at the end of this letter.

   Prospectus Summary, page 1
1. We note our prior Comment 7, your response and reissue the
comment.  The summary section should be a balanced discussion of
the
most significant factors that relate to your offering.  You should
revise to provide more disclosure regarding any negative aspects
of
your company`s experiences, strategy and prospects.  Adding one
paragraph at the end of the summary is not sufficient.  The entire
summary should be balanced, starting with the first paragraph and
following throughout.
2. We note our prior Comment 9, your response and reissue the
comment.  Vantas and almost all of your potential products are
based
on your Hydron Technology.  Therefore, you should state in the
very
first sentence that Vantas and your potential products concern
drug
delivery.
3. We note our prior Comment 9, your response and reissue the
comment.  In your original filing, you stated on page 9 that
implantation "is generally less well received by patients than
injection therapy."  Provide this disclosure in the carryover
paragraph on pages one and two.
4. Please expand the carryover paragraph on pages one and two to
state that Hydron Technology is limited by the amount of drug
which
can be loaded into an implant due to its small size, the inability
of
the technology to deliver drugs that are water insoluble and the
need
for a minor surgical procedure to insert and remove the implant.

   Competitive Strengths, page 2
5. You state that implants using Hydron Technology can be adapted
to
deliver many different drugs.  Given that you have received FDA
approval for Vantas only, we believe you should either qualify
this
statement as being your belief or delete it.
6. As to Vantas, please state whether or not you achieved "fast
track," "accelerated" or some similar type of approval for Vantas
and
whether you are seeking or plan to seek this type of review or
approval for your other drug candidates.
7. As you have chosen to include a summary of your strategy,
please
revise to include a discussion of the risks and obstacles you must
address in implementing this strategy.

   Risk Factors, page 7

   We have a history..., page 7
8. You have added the word "sustain" throughout this risk factor
where you discuss profitability.  Since you have never made a
profit
you should not discuss sustaining profitability.

   We are dependent on single suppliers..., page 7
9. We note our prior Comment 21 and reissue it in part.  Identify
all
sole source suppliers.

   We may be unable to obtain additional capital..., page 8
10. Please state the amount of the royalty payments you made which
are tied to sales of Vantas.

   Because we have operated as a private company..., page 12
11. We note our prior Comment 27, your response, and reissue in
part.
State whether you anticipate questions regarding your current
systems
and controls.  Also, describe in more detail what additional
resources will be required and where you believe your resources
may
be deficient.

   Use of Proceeds, page 22
12. We note our prior Comment 33, your response and reissue the
comment.  For each of the indications for the drug candidates that
you intend to conduct clinical trials for using these proceeds,
disclose the stage of the FDA approval process you expect to
complete
using the proceeds.

   Management`s Discussion and Analysis of Financial Condition and
Results of Operations
13. We acknowledge your response to our comment 36 with regards to
further disclosure of your research and development projects in
process but feel that the revised disclosure is not fully
responsive
to our comment.  Please provide the following disclosures:

a. The costs incurred during each period presented and to date for
each project.  If you do not maintain any research and development
costs by project, disclose that fact and explain why management
does
not maintain and evaluate research and development costs by
project.
Provide other quantitative or qualitative disclosure that
indicates
the amount of the company`s resources being used on the project.

b.c. and d. We acknowledge your response about the risks and
uncertainties associated with completing your research and
development projects.  You state in your response letter that "the
Company believes that selective disclosure of its known future
development costs for some products or product candidates and not
others could be misleading to prospective investors".  In your S-
1/A
filed on April 20, 2004, page 30, you stated "you cannot
reasonably
estimate or know the nature, timing and estimated expenses of the
efforts necessary to complete the development of .......from any
of
our product candidates".   We continue to believe that what ever
future development costs for products or product candidates are
known
for a particular phase should be disclosed as requested in our
original comment.  To the extent that future development costs for
certain phases are not known, please state such and disclose why
these costs are not known and why (facts and circumstances) a
reasonable estimate or range cannot be made.
14. We acknowledge your response to our comment number 37
regarding
critical accounting estimates and policies that estimates at this
point have not been material nor are changes in estimates
reasonably
likely to be material.  We continue to believe that your
disclosure
should eliminate the duplication contained in the notes to your
financial statements.

   Business, page 39

15. Where you provide similar or the same disclosure here as in
the
Summary, please comply with the above comments regarding the
Summary
here as well.

   VP002, page 41
16. We note our prior Comment 43, your response and reissue the
comment.  You state that results from your Phase II clinical trial
showed that all patients were hormonally suppressed.  Please
quantify
this result and explain what clinically relevant means and what
percentage is needed to meet this threshold.
Description of Capital Stock, page 73
17. We note our prior Comment 56 and your response.  On page 74,
disclose what a "qualified offering" is and state here that if the
offering is not a "qualified offering," you have not determined
whether or not you will proceed with the offering.  Also, note
that
if after circulating prospectuses you determine that the offering
will not be a qualified offering and you choose to proceed, you
may
have to provide additional disclosure to investors.

   Notes to Financial Statements

   Note 2 Revenue Recognition, F-10
18. We acknowledge your response to comment 62 and your
evaluations
in meeting the requirements set forth by paragraph 6 and 8 of FAS
48.
With regards to your response to the additional factors that may
impair the ability to make a reasonable estimate for returns, you
state in response to paragraph 8.c. of FAS 48, that you have
employees who have sold similar products with similar types of
sales
methods.  You state that you have used this experience in
evaluating
likely return patterns.  Since your product was only approved by
the
FDA in October 2004 and represents your sole product being sold,
tell
us supplementally the relevance of the information derived from
your
employees experienced in similar matters in evaluating paragraph
8.c.
You also state your sales specialists generally confirm
utilization
of the product and inventory on hand at each customer site to
evaluate the likelihood of return.  Tell us supplementally the
methodology that all your sales specialists use in evaluating the
likelihood of returns, how you compile this data and use it in
formulating your estimate to conclude that you can reasonably
estimate returns

   Note 2 Allowance for Accounts Receivable, F-11
19. We have read your response and revised disclosure to comment
63
of our April 11, 2005 comment letter. Please confirm that when the
accounts receivable for which the return would be applicable is no
longer outstanding that you have the right of set off as required
by
FIN 39 for receivables unrelated to returned goods.

   Note 9. Stock Options, F-18
20. We may have further comment regarding your response to
comments
64 when you include the offering price in your registration
statement.

Recent Sales of Unregistered Securities, page II-2
21. We note our prior Comment 67 and reissue it in part.  For each
of
the sales of unregistered securities mentioned in Item 15(a),
state
in the registration statement to how many accredited investors you
sold securities.

*	*	*

      As appropriate, please amend your filing in response to
these
comments.  You may wish to provide us with marked copies of the
amendment to expedite our review.  Please furnish a cover letter
with
your amendment that keys your responses to our comments and
provides
any requested supplemental information.  Detailed cover letters
greatly facilitate our review.  Please file your cover letter on
EDGAR under the form type label CORRESP. Please understand that we
may have additional comments after reviewing your amendment and
responses to our comments.

      We direct your attention to Rules 460 and 461 regarding
requesting acceleration of a registration statement.  Please allow
adequate time after the filing of any amendment for further review
before submitting a request for acceleration.  Please provide this
request at least two business days in advance of the requested
effective date.

      You may contact Christine Allen at (202) 824-5533 or James
Rosenberg at (202) 942-1803 if you have questions regarding
comments
on the financial statements and related matters.  Please contact
Michael Reedich at (202) 942-1815 or me at (202) 942-1840 with any
other questions.

      Sincerely,

      Jeffrey Riedler
      Assistant Director

cc:	Robert B. Murphy, Esq.
	Pepper Hamilton LLP
	600 14th Street, N.W.
	Washington, DC 20005-2004

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