SEC Company Response from ENZON PHARMACEUTICALS, INC. (ENZN) (CIK 0000727510) (VISK) — Aug 13, 2012
ENZON PHARMACEUTICALS, INC. (ENZN) (CIK 0000727510)
Date: Aug. 13, 2012 · CIK: 0000727510 · Accession: 0001144204-12-044890
AI Filing Summary & Sentiment
Reasoning
File numbers found in text: 000-12957
Referenced dates: July 30, 2012
Letter
VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance Form 10-K for the Fiscal Year Ended December 31, 2011 Filed March 12, 2012 File No. 000-12957
Re: Enzon Pharmaceuticals, Inc.
Dear Mr. Rosenberg:
This letter sets forth the responses of Enzon Pharmaceuticals, Inc. (the “Company”) to the comments raised in the letter dated July 30, 2012 (the “Comment Letter”) from the staff (the “Staff”) of the United States Securities and Exchange Commission (the “Commission”) related to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2011 filed on March 12, 2012 (the “2011 Form 10-K”). Set forth below are the Company’s responses to the Staff’s comments as set forth in the Comment Letter. To facilitate your review, the Staff’s comments set forth in the Comment Letter are reprinted below in italics, numbered to correspond with the paragraph numbers assigned in the Comment Letter, and are followed by the corresponding response from the Company.
Santarus Pharma A/S License Agreement, page 12
1. We note your disclosure stating that Santarus may terminate the agreement with respect to specific LNA compounds if you do not achieve certain development milestones for that product. Please discuss the development milestones that must be achieved and the timeframe for achieving them as to each of the three pipeline products being developed as a result of this agreement. Also disclose the year in which the royalty term will expire as to each of the three pipeline products in each country where patents have been issued or where patent applications are pending.
Response:
Under the Company’s license agreement with Santaris Pharma A/S (as amended, the “Santaris License Agreement”), the Company has licensed several LNA compounds consisting of messenger ribonucleic acid (mRNA) antagonists directed against novel oncology targets. The three pipeline products being developed as a result of the Santaris License Agreement consist of (i) a mRNA antagonist targeting Hypoxia-Inducible Factor-1 alpha, (ii) a mRNA antagonist targeting Survivin and (iii) a mRNA antagonist targeting the androgen receptor. The other mRNA antagonists to which the Company has rights under the Santaris License Agreement remain in early stages of preclinical study.
Mr. Jim B. Rosenberg, Senior Assistant Chief Accountant
United States Securities and Exchange Commission
August 13, 2012
Page 2
As disclosed in the 2011 Form 10-K, the Santaris License Agreement provides that Santaris Pharma A/S can terminate the agreement with respect to a specific LNA compound if the Company does not achieve certain time-based development milestones for that product. With respect to the three pipeline products, the Company has already achieved these time-based development milestones. Because these milestones have already been achieved, the Company does not consider these milestones relevant information for disclosure to investors. With respect to the other mRNA antagonists licensed under the Santaris License Agreement, the Company has yet to achieve these time-based development milestones. However, because these other mRNA antagonists remain in early stages of preclinical study and it is not known whether or when any of these mRNA antagonists will enter clinical trials, the Company also does not consider these development milestones relevant information for disclosure to investors. Nevertheless, to clarify the above in the Company’s disclosure, the Company proposes to include disclosure to the following effect under “Item 1. “Business – Development and Commercialization Agreements – Santaris Pharma A/S License Agreement” in its next Annual Report on Form 10-K:
“The license agreement provides that Santaris can terminate the agreement with respect to a specific LNA compound provided by Santaris if we do not achieve certain time-based development milestones for that product. These time-based development milestones were achieved for the HIF-1 alpha, Survivin and AR antagonists, but remain to be achieved for the other antagonists licensed under the license agreement.”
With respect to the Staff’s request that the Company disclose the years in which the royalty terms will expire as to each of these three pipeline products, the Company will disclose the years in which the royalty terms will expire as to the mRNA antagonist targeting Hypoxia-Inducible Factor-1 alpha and the mRNA antagonist targeting the androgen receptor. However, in periodic filings subsequent to the 2011 Form 10-K, the Company disclosed that it does not intend to proceed with the clinical development of Survivin at this time. Accordingly, the Company does not believe that disclosure of the year in which the royalty term will expire as to the mRNA antagonist targeting Survivin would be material to investors. In this regard, to address the Staff’s request, the Company proposes to include disclosure to the following effect under “Item 1. “Business – Development and Commercialization Agreements – Santaris Pharma A/S License Agreement” in its next Annual Report on Form 10-K:
“The royalty term for the mRNA antagonist targeting Hypoxia-Inducible Factor-1 alpha will expire in 2023 in the U.S. and countries where patents have been issued or where patent applications are pending. The royalty term for the mRNA antagonist targeting the androgen receptor will expire in 2028 in the U.S. and countries where patents have been issued or where patent applications are pending.”
Mr. Jim B. Rosenberg, Senior Assistant Chief Accountant
United States Securities and Exchange Commission
August 13, 2012
Page 3
Patents and Intellectual Property Rights, page 15
2. We note your disclosure indicating that the original patent covering the Company’s PEG technology has expired and that current patents cover improved methods of attaching PEG to therapeutic compounds and PEG-modified compounds that the company has identified or created. It is unclear whether any of these current patents are material to your business. Please provide expiration dates for any of these patents if they are material or, alternatively, please provide a supplemental analysis detailing why they are not material to your business. Also, please provide the jurisdiction and expiration dates of any material patents related to any of the three pipeline products being developed as a result of the agreement with Santarus.
Response:
With respect to the Staff’s request that the Company provide expiration dates for the original patent covering the Company’s PEG technology and current patents covering improved methods of attaching PEG to therapeutic compounds and PEG-modified compounds that the Company has identified or created, based upon the Company’s consideration of the disclosure included in the 2011 Form 10-K and Item 101(c)(1)(iv) of Regulation S-K, the Company does not consider the expiration dates for these patents relevant information for disclosure to investors. Rather, the Company considers the expirations of the Company’s right to receive royalties with respect to these patents to be the most relevant information for disclosure to investors and, accordingly, the Company included this information on pages 12 and 13 of the 2011 Form 10-K.
With respect to the Staff’s request that the Company provide the jurisdiction and expiration dates of any material patents related to any of the three pipeline products being developed as a result of the Santaris License Agreement, the Company proposes to include disclosure to the following effect with respect to the mRNA antagonist targeting Hypoxia-Inducible Factor-1 alpha and the mRNA antagonist targeting the androgen receptor under “Item 1. “Business – Development and Commercialization Agreements – Santaris Pharma A/S License Agreement” in its next Annual Report on Form 10-K:
“The patents related to the mRNA antagonist targeting Hypoxia-Inducible Factor-1 alpha are expected to expire as late as 2026 in the U.S. (not including any patent term extensions) and internationally in 2025 (not including any patent term extensions). The patents related to the mRNA antagonist targeting the androgen receptor are expected to expire as late as 2028 in the U.S. and internatio
Show Raw Text
CORRESP
1
filename1.htm
August 13, 2012
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F. Street, N.E.
Washington, D.C. 20549
Attn: Mr. Jim B. Rosenberg, Senior Assistant Chief Accountant
Re: Enzon Pharmaceuticals, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2011
Filed March 12, 2012
File No. 000-12957
Dear Mr. Rosenberg:
This letter sets forth
the responses of Enzon Pharmaceuticals, Inc. (the “Company”) to the comments raised in the letter dated July
30, 2012 (the “Comment Letter”) from the staff (the “Staff”) of the United States Securities
and Exchange Commission (the “Commission”) related to the Company’s Annual Report on Form 10-K for the
fiscal year ended December 31, 2011 filed on March 12, 2012 (the “2011 Form 10-K”). Set forth below are the
Company’s responses to the Staff’s comments as set forth in the Comment Letter. To facilitate your review, the Staff’s
comments set forth in the Comment Letter are reprinted below in italics, numbered to correspond with the paragraph numbers assigned
in the Comment Letter, and are followed by the corresponding response from the Company.
Santarus Pharma A/S License Agreement,
page 12
1. We
note your disclosure
stating that Santarus
may terminate the
agreement with respect
to specific LNA
compounds if you
do not achieve certain
development milestones
for that product.
Please discuss the
development milestones
that must be achieved
and the timeframe
for achieving them
as to each of the
three pipeline products
being developed
as a result of this
agreement. Also
disclose the year
in which the royalty
term will expire
as to each of the
three pipeline products
in each country
where patents have
been issued or where
patent applications
are pending.
Response:
Under the Company’s license
agreement with Santaris Pharma A/S (as amended, the “Santaris License Agreement”), the Company has licensed
several LNA compounds consisting of messenger ribonucleic acid (mRNA) antagonists directed against novel oncology targets. The
three pipeline products being developed as a result of the Santaris License Agreement consist of (i) a mRNA antagonist targeting
Hypoxia-Inducible Factor-1 alpha, (ii) a mRNA antagonist targeting Survivin and (iii) a mRNA antagonist targeting the androgen
receptor. The other mRNA antagonists to which the Company has rights under the Santaris License Agreement remain in early stages
of preclinical study.
Mr. Jim B. Rosenberg, Senior Assistant Chief Accountant
United States Securities and Exchange Commission
August 13, 2012
Page 2
As disclosed in the 2011 Form
10-K, the Santaris License Agreement provides that Santaris Pharma A/S can terminate the agreement with respect to a specific
LNA compound if the Company does not achieve certain time-based development milestones for that product. With respect to the three
pipeline products, the Company has already achieved these time-based development milestones. Because these milestones have already
been achieved, the Company does not consider these milestones relevant information for disclosure to investors. With respect to
the other mRNA antagonists licensed under the Santaris License Agreement, the Company has yet to achieve these time-based development
milestones. However, because these other mRNA antagonists remain in early stages of preclinical study and it is not known whether
or when any of these mRNA antagonists will enter clinical trials, the Company also does not consider these development milestones
relevant information for disclosure to investors. Nevertheless, to clarify the above in the Company’s disclosure, the Company
proposes to include disclosure to the following effect under “Item 1. “Business – Development and Commercialization
Agreements – Santaris Pharma A/S License Agreement” in its next Annual Report on Form 10-K:
“The license agreement
provides that Santaris can terminate the agreement with respect to a specific LNA compound provided by Santaris if we do not achieve
certain time-based development milestones for that product. These time-based development milestones were achieved for the HIF-1
alpha, Survivin and AR antagonists, but remain to be achieved for the other antagonists licensed under the license agreement.”
With respect to the Staff’s
request that the Company disclose the years in which the royalty terms will expire as to each of these three pipeline products,
the Company will disclose the years in which the royalty terms will expire as to the mRNA antagonist targeting Hypoxia-Inducible
Factor-1 alpha and the mRNA antagonist targeting the androgen receptor. However, in periodic filings subsequent to the 2011 Form
10-K, the Company disclosed that it does not intend to proceed with the clinical development of Survivin at this time. Accordingly,
the Company does not believe that disclosure of the year in which the royalty term will expire as to the mRNA antagonist targeting
Survivin would be material to investors. In this regard, to address the Staff’s request, the Company proposes to include
disclosure to the following effect under “Item 1. “Business – Development and Commercialization Agreements –
Santaris Pharma A/S License Agreement” in its next Annual Report on Form 10-K:
“The royalty term for
the mRNA antagonist targeting Hypoxia-Inducible Factor-1 alpha will expire in 2023 in the U.S. and countries where patents have
been issued or where patent applications are pending. The royalty term for the mRNA antagonist targeting the androgen receptor
will expire in 2028 in the U.S. and countries where patents have been issued or where patent applications are pending.”
Mr. Jim B. Rosenberg, Senior Assistant Chief Accountant
United States Securities and Exchange Commission
August 13, 2012
Page 3
Patents and Intellectual Property Rights,
page 15
2. We
note your disclosure
indicating that
the original patent
covering the Company’s
PEG technology has
expired and that
current patents
cover improved methods
of attaching PEG
to therapeutic compounds
and PEG-modified
compounds that the
company has identified
or created. It is
unclear whether
any of these current
patents are material
to your business.
Please provide expiration
dates for any of
these patents if
they are material
or, alternatively,
please provide a
supplemental analysis
detailing why they
are not material
to your business.
Also, please provide
the jurisdiction
and expiration dates
of any material
patents related
to any of the three
pipeline products
being developed
as a result of the
agreement with Santarus.
Response:
With respect to the Staff’s
request that the Company provide expiration dates for the original patent covering the Company’s PEG technology and current
patents covering improved methods of attaching PEG to therapeutic compounds and PEG-modified compounds that the Company has identified
or created, based upon the Company’s consideration of the disclosure included in the 2011 Form 10-K and Item 101(c)(1)(iv)
of Regulation S-K, the Company does not consider the expiration dates for these patents relevant information for disclosure to
investors. Rather, the Company considers the expirations of the Company’s right to receive royalties with respect to these
patents to be the most relevant information for disclosure to investors and, accordingly, the Company included this information
on pages 12 and 13 of the 2011 Form 10-K.
With respect to the Staff’s
request that the Company provide the jurisdiction and expiration dates of any material patents related to any of the three pipeline
products being developed as a result of the Santaris License Agreement, the Company proposes to include disclosure to the following
effect with respect to the mRNA antagonist targeting Hypoxia-Inducible Factor-1 alpha and the mRNA antagonist targeting the androgen
receptor under “Item 1. “Business – Development and Commercialization Agreements – Santaris Pharma A/S
License Agreement” in its next Annual Report on Form 10-K:
“The patents related to
the mRNA antagonist targeting Hypoxia-Inducible Factor-1 alpha are expected to expire as late as 2026 in the U.S. (not including
any patent term extensions) and internationally in 2025 (not including any patent term extensions). The patents related to the
mRNA antagonist targeting the androgen receptor are expected to expire as late as 2028 in the U.S. and internatio