SecProbe.io

<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>

Mail Stop 3-9								April 11, 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
      Filed March 14, 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.

General
1. Please complete all of the blank sections of your filing prior
to
filing the next amendment.
2. Please provide us proofs of all graphic, visual or photographic
information you will provide in the printed prospectus prior to
its
use, for example in a preliminary prospectus.  Please note we may
have comments regarding this material.

3. Please note that when you file a pre-effective amendment
containing pricing-related information, we may have additional
comments.  As you are likely aware, you must file this amendment
prior to circulating the prospectus.
4. Please note that when you file a pre-effective amendment that
includes your price range, the range must be bone fide.  We
interpret
this to mean that your range may not exceed $2 if you price below
$20
and 10% if you price above $20.
5. We note that you plan to sell securities using a directed share
program.  Please provide us with any material you intend to sell
to
potential purchasers such as a "friends and family" letter.  Tell
us
when you intend to send them to these potential purchasers.  Tell
us
whether the sale will be handled by you directly or by the
underwriting syndicate.  Tell us the procedures you or the
underwriter will employ in making the offering and how you will
assure that this offer will meet the requirements of Section 5 of
the
Securities Act and Rule 134.  We may have further comments.
6. Throughout the registration statement, you cite various
estimates,
statistics and other figures, and reference beliefs you have.
Where
you cite your own estimates, please explain how you arrived at
those
estimates, disclose any third-party sources you relied upon, and
provide us with any copies of those sources.  Copies delivered
should
be marked to highlight the relevant information.  For all other
figures and statements, please identify your sources and provide
copies of these sources to us. Set forth below is an illustrative
and
not an exhaustive list of statements that should be supported:
(a) "The total number of patients with advanced prostate cancer in
the U.S. was approximately 652,000 in 2004, and we estimate the
patient population in Europe to be of similar size."
(b) "The prevalence of this condition is estimated to be between
one
in 5,000 to 10,000 children. This yields a potential population of
up
to 11,700 children who are 14 or younger with this condition in
the
U.S."
(c) "We believe that there are approximately 1,000 new acromegalic
patients per year in the U.S. and 16,000 total patients."
(d) "We estimate the U.S. acromegalic market to be $160 million
annually, consisting primarily of monthly injections of
octreotide."
(e) "...generic drug companies do not typically have field sales
forces."
(f) "There are approximately 700 pediatric endocrinologists in the
U.S., and most of them are located in the same major metropolitan
areas as the urologists we are calling on for Vantas."
(g) "There are 214 registered addiction medicine specialists
practicing in the U.S."
(h) "We believe that such predictable release over a period of 12
months has not been achieved by most other drug delivery systems,
including sustained release injections, bioerodible implants and
transdermal devices."

   Prospectus Summary, page 1
7. The summary section should be a balanced discussion of the most
significant factors that relate to your offering.  Currently, your
summary is a detailed discussion of mainly the positive aspects of
Vantas, and your company`s drug candidates under development and
strategy.  You should revise to provide more disclosure regarding
any
negative aspects of your company`s experiences, strategy and
prospects.
8. In the first sentence, you state that you are a fully-
integrated
specialty pharmaceutical company.  We note that you rely on third
parties for services, raw materials and the performance of trials.
Therefore, it appears that you are not "fully-integrated."  Please
revise.
9. 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.
10. Please explain in Plain English what "palliative treatment"
is.
Also, please explain similar terms the first time they are used in
the prospectus.
11. We note your use of the term "Phase I/II" regarding your
completed and currently ongoing clinical trials regarding your
potential products.  The use of the term "Phase I/II" should only
be
used if your trial met all the FDA requirements for a Phase II
study.
Please tell us whether or not your Phase I/II trial met all of the
requirements of Phase II clinical trials.  We note that Phase II
trials typically involve administering the product under
development
to 100-300 participants, allowing for the evaluation of the
effectiveness of the drug and determining the short-term side
effects
and risks.  Has the FDA agreed that your respective studies were
designed to meet the requirements of Phase II trials?  For any of
your studies not designed to meet all requirements of FDA approved
Phase II clinical trials, please delete the references to "Phase
I/II," replace the references with the term "Phase I" and explain
that the trials are designated to provide information related to
the
efficacy, not the effectiveness, of the product candidate.  This
comment also applies to your references to "Phase II/III"
throughout
the prospectus.
12. At the bottom of page 1, you state that you believe that
Vantas
is a more comfortable and convenient alternative to competing
products because it eliminates the requirement of multiple
physician
visits and repeated injections and is smaller, softer and more
flexible than other implants.  You should balance this disclosure
by
stating that implantation is generally less well received by
patients
than injection therapy.

   Competitive Strengths, page 2
13. You state that implants using Hydron Technology can be adapted
to
deliver many different drugs.  Given that you have only received
FDA
approval for Vantas only, we believe you should either qualify
this
statement as being your belief or delete it.
14. 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.
15. 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

   General
16. In the preamble, you state, "If any of the following risk
factors, as well as other risks and uncertainties that are not
currently known to us or that we currently believe are not
material
(italics add), actually occur, our business, financial condition
and
results of operations could be materially and adversely affected."
Please amend the preamble to state that all known material risks
are
articulated in the risk factors section and delete the italicized
language.
17. Many of your risk factors are generic in that they could apply
to
almost any company that develops drugs.  Also, some of the risk
factors merely state facts and circumstances without explaining
how
those facts and circumstances pose risks to investors and what
will
happen if those risks come to fruition.  The company`s "business,
results of operations and financial condition" being adversely
affected is not specific enough to communicate the risk.  Please
amend the risk factors to include specific disclosure and language
explaining exactly what risks you face.  We expect that you will
substantially amend many of the risk factors in response to this
comment.
18. Where you lay out bullet points highlighting specific risk
factors or embedded lists, please elaborate on any problems you
have
faced in the past relating to those bullet points.  Please note
that
in doing so, your resulting disclosure might become significant
enough to warrant a separate risk factor.  We may have further
comments on your disclosure.
19. Consider creating a risk factor which discusses any side
effects
and adverse reactions you have observed thus far in testing your
product candidates.

   We have a history..., page 7
20. Quantify the costs of your research and development activity
that
have principally caused your losses and state whether or not you
anticipate that your losses will grow as you incur significant
operating expenses going forward.

   We are dependent on single suppliers..., page 7
21. You state that you have many single-supplier arrangements for
raw
materials and services.  Please consider expanding the risk factor
which discloses the inherent risks of these arrangements.
Identify
all sole source suppliers.  To the extent that you have written
agreements with such sole source suppliers, file the agreements as
exhibits or provide us with the basis for your determination that
it
is not required.

   We may be unable to obtain additional capital..., page 8
22. Please state how long you expect the proceeds of this offering
to
fund your operations and when you believe you will need to raise
additional capital.

   The successful commercialization..., page 8
23. You state that your current sales of Vantas may be supported,
in
part, by favorable reimbursement rates, which you expect will
decrease in the second half of 2005.  Please state and highlight
in
the title to the risk factor, the reason for this projected
decrease
and provide more detailed disclosure in MD&A.

   Our failure to retain, recruit..., page 9
24. You state that you utilize consultants.  Please expand this
risk
factor to state whether or not your contracts with these
consultants
specifically contain provisions stating that all intellectual
property they develop belongs to the company and the related
risks.
25. Please expand the discussion to indicate the extent to which
you
have employment agreements with and key man insurance for your
senior
management and key scientific and technical personnel.

   Our sales of Vantas..., page 10
26. Please state whether or not you are aware of any generic
substitutes for any of your products currently being developed.
If
there are, name them.

   Because we have operated as a private company..., page 11
27. This risk factor is not at all specific to your company.
State
whether any of your current systems and controls are not in
compliance, are insufficient, are being questioned or whether you
anticipate questions regarding them.  Please state whether or not
you
or your auditors have identified any material weaknesses or
significant deficiencies in your internal controls.  We may have
further comments once we have seen your proposed response to this
comment.

   If our clinical trials..., page 12
28. The disclosure in this risk factor is generic, in that it
could
apply to any company in your business.  Please revise to highlight
the risks specific to your company.
29. Please describe any problems you have had in the past with the
risks you have posed in this section and the other risk factors in
this section.
30. Disclose the side effects and adverse reactions you have
observed
thus far in testing your drug candidates.
31. Describe any past incidence of non-compliance with the
regulatory
requirements to which you allude.

Forward-Looking Statements, page 20
32. You state, "This prospectus also contains or refers to market
data and industry statistics, forecasts and projections that we
obtained from industry publications and publicly-available data.
These sources generally indicated that they have obtained their
information from sources believed to be reliable, but do not
guarantee the accuracy or completeness of their information. We do
not guarantee, and we have not independently verified this
information. Accordingly, investors should not place undue
reliance
on this information."  Please delete this paragraph, as it is not
appropriate to disclaim the statistics and other data it
encompasses
or delete all such information from the prospectus.

   Use of Proceeds, page 21
33. Please state how much of the proceeds of the offering are
expected to be allocated to each of the matters you mention in the
bullets.  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.

   Capitalization, page 23
34. Please expand the "Convertible Preferred Stock" line item to
include the number of shares authorized, issued and outstanding in
each case appearing in the column captions.
Management`s Discussion and Analysis of Financial Condition and
Results of Operations
35. We acknowledge your "product development" table summarizing
your
product candidates. Please expand your disclosure by referring to
the
Division of Corporation Finance "Current Issues and Rulemaking
Projects Quarterly Update" under section VIII - Industry Specific
Issues - Accounting and Disclosure by Companies Engaged in
Research
and Development Activities.  You can find it at the following
website
address:
http://www.sec.gov/divisions/corpfin/cfcrq032001.htm#secviii.
36. Please disclose the following information for each of your
major
research and development projects:
a. The costs incurred during each period presented and to date on
the
project;
b. The nature, timing and estimated costs of the efforts necessary
to
complete the project;
c. The anticipated completion dates;
d. The risks and uncertainties associated with completing
development
on schedule, and the consequences to operations, financial
position
and liquidity if the project is not completed timely; and finally
e. The period in which material net cash inflows from significant
projects are expected to commence.

Regarding a., 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.

Regarding b. and c., disclose the amount or range of estimated
costs
and timing to complete the phase in process and each future phase.
To
the extent that information is not estimable, disclose those facts
and circumstances indicating the uncertainties that preclude you
from
making a reasonable estimate.
37. In your critical accounting policies and estimates, please
eliminate the duplication that is disclosed in your financial
statements related to account