corresp
[GTx Letterhead]
January 19, 2011
Via EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
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Attn:
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Jeffrey Riedler |
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Johnny Gharib |
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Jennifer Riegel |
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Re:
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GTx, Inc. |
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Form 10-K |
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Filed March 15, 2010 |
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File No. 000-50549 |
Ladies and Gentlemen:
On behalf of GTx, Inc. (the Company), this letter is being transmitted in response to comments
received from the staff (the Staff) of the Securities and Exchange Commission (the Commission)
by letter dated January 10, 2011 (the Comment Letter) regarding the Companys response letter
dated December 21, 2010 (the Prior Response Letter) to the comments received from the Staff by
letter dated December 15, 2010. The text of the Staffs comments has been included in this
response letter in italics for your convenience, and the numbering of the paragraphs below
correspond to the numbering of the Comment Letter.
Form 10-K, filed March 15, 2010
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We note your response to prior comment 1 and your proposed disclosure which states a
range of royalties of a low double-digit in regard to the Orion agreement. Please revise
your proposed disclosure to include a range of royalty rates not to exceed ten percent.
Your current proposed disclosure of a low double-digit royalty is not specific enough to
clarify that the range does not exceed ten percent. |
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Response: |
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In response to the Staffs comment, the Company has revised its proposed disclosure of the
Orion agreement for its 2010 Form 10-K to more specifically describe the royalty payable to
Orion with respect to sales by us, our affiliates and third-party sublicensees, as
applicable, of FARESTON® and other toremifene-based products. In this regard, the Company
respectfully advises the Staff that under the Orion agreement, there is currently only one
royalty rate applicable to such sales, which the Company has described as being in the low
teens in its revised proposed disclosure. The revised |
Securities and Exchange Commission
January 19, 2011
Page Two
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proposed disclosure for the Companys 2010 Form 10-K is set forth on Exhibit A attached
hereto. |
Intellectual Property, page 19
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We note your response to prior comments 2 and 3. To the extent that foreign patents
and patent applications in Europe, Asia and other jurisdictions are material to your
business, please provide draft disclosure to be included in your 2010 Form 10-K stating the
countries in which these foreign patents are issued and where other patent applications are
pending. |
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Response: |
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In response to the Staffs comment, the Company has revised its proposed disclosure for its
2010 Form 10-K with respect to the countries in which foreign patents are issued and where
other patent applications are pending, as reflected in the updated proposed disclosure as
set forth on Exhibit B attached hereto. |
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With respect to the updated proposed disclosure, the Company respectfully advises the Staff
that the Company currently commercializes only one product and only in the United States,
and that the Companys own sales and marketing efforts, if any, for its current or potential
future product candidates that may be approved for commercial sale would be focused in the
United States. As a result, U.S. patents and patent applications are generally the most
important and potentially valuable to the Company. The Companys commercialization strategy
for any of its current and potential future product candidates that may be approved for
commercial sale also includes partnering commercial rights to third parties in regions
outside of the United States, but to date, none of such product candidates have been
approved for commercial sale. With respect to regions outside of the United States, the
Companys owned and licensed patent portfolios are complex, are obtained over time and the
patents and patent applications included in such portfolios are issued or pending, as
applicable, in a significant number of countries around the world. Because the Companys
product candidates have not received marketing approval in any jurisdiction, the Company is
proposing to list in its updated proposed disclosure the countries that the Company
currently believes represent potential major market opportunities for its product candidates
(if such product candidates receive the requisite marketing approvals and the Company is
able to establish and maintain relationships with third parties to commercialize such
product candidates in such jurisdictions). In this regard, the Company undertakes to revisit
its patent and intellectual property disclosures in its filings with the Commission in
connection with future changes to the Companys commercialization or partnering strategies,
as well as future changes to its business resulting from any approved products. |
* * * * *
Securities and Exchange Commission
January 19, 2011
Page Two
The Company further acknowledges that:
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the Company is responsible for the adequacy and accuracy of the disclosure in the
filings; |
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Staff comments or changes to disclosure in response to Staff comments do not foreclose
the Commission from taking any action with respect to the filings; and |
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the Company may not assert Staff comments as a defense in any proceeding initiated by
the Commission or any person under the federal securities laws of the United States. |
Please do not hesitate to contact me at (901) 507-6916 or Chad Mills at (650) 843-5654 of Cooley
LLP, outside counsel to the Company, if you have any questions or would like additional information
regarding these matters.
Sincerely,
/s/ Henry P. Doggrell
Henry P. Doggrell
Vice President and General Counsel
GTx, Inc.
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cc: |
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Mitchell S. Steiner, Chief Executive Officer
Marc S. Hanover, President and Chief Operating Officer
Chadwick L. Mills, Cooley llp |
EXHIBIT A
Orion Corporation
In March 2000, we entered into a license and supply agreement with Orion to develop and
commercialize products containing toremifene. Our rights under the original license agreement were
limited to specific disease fields pertaining to prostate cancer. In December 2004, we entered into
an agreement with Orion to purchase specified FARESTON® related assets which Orion had
re-acquired from another licensee. We also entered into an amended and restated license and supply
agreement in January 2005 with Orion which replaced the original license agreement. We paid Orion
approximately $5.2 million under the 2004 agreements for the assets and related license rights.
Under the amended and restated license and supply agreement, we obtained an exclusive license
from Orion to develop and commercialize toremifene-based products for all human indications
worldwide, except breast cancer outside of the United States. We are required to pay Orion a
portion of certain types of upfront and milestone income that we receive from third-party
sublicensees, after we recover our clinical development costs, and a royalty in the low-teens on
sales by us and our affiliates of FARESTON® for breast cancer in the United States. We are also
required to pay Orion a royalty in the low-teens on sales by us, our affiliates and third-party
sublicensees of other toremifene-based products, including toremifene 80 mg and toremifene 20 mg if
approved for commercial sale. Our license and supply agreement with Orion requires that Orion will
manufacture and supply all of our and our sublicensees needs for clinical trial and commercial
grade material for toremifene-based products developed and marketed in the United States and
abroad, including toremifene globally and FARESTON® in the United States. Orion has the
right to terminate its supply obligations at its election at any time as a result of our failure to
obtain regulatory approval of one of our toremifene product candidates in the United States prior
to December 31, 2009, in which event we will have the right to enter into a contract manufacturing
agreement with another supplier for toremifene-based products. However, any arrangements we make
for an alternative supply would have to be made with a qualified alternative supplier with
appropriate FDA approval in order for us to obtain our supply requirements for toremifene. The term
of the amended and restated license and supply agreement lasts, on a country-by-country basis,
until the later of expiration of our own patents claiming the processes or the methods of use of
toremifene for prostate cancer or the end of all marketing or regulatory exclusivity which we may
obtain for toremifene-based products. The term of our issued and pending method of use patents
pertaining to toremifene for prostate cancer extend from 2019 to 2025. Orion may terminate the
amended and restated license and supply agreement, on a country-by-country basis, as a result of
our uncured material breach, including under certain circumstances if we decided not to
commercially launch toremifene in any major country after we obtain regulatory approval in such
country, or our bankruptcy. Following the termination of the amended and restated license and
supply agreement by Orion for our material breach, we will grant a royalty-bearing license to Orion
to enable Orion to continue the development and commercialization of toremifene-based products in
the countries in which the agreement is terminated.
A-1
EXHIBIT B
For toremifene in the United States and internationally, we have entered into an amended
and restated license and supply agreement with Orion Corporation granting us an exclusive license
under Orions patents covering the composition of matter of toremifene for all uses in humans in
the United States, and for all human uses outside the United States other than the treatment and
prevention of breast cancer. However, Orions patent for toremifene expired in the United States in
September 2009 and foreign counterparts of this patent also have expired. As a result, we will need
to rely primarily on the protection afforded by the method of use patents that either have been
already issued or may later issue from our owned or licensed patent applications.
We have exclusively licensed from UTRF method of use patents and pending patent applications
for specific disease indications and doses in the United States, and have licensed issued and
pending patent applications in Canada, Australia, Japan, China and other countries in Asia, and
before the European Patent Office designating Germany, Great Britain, Spain, France, Italy and
other European Union countries, as well as in certain other countries outside those regions,
related to the use of toremifene 20 mg for the reduction in the incidence of prostate cancer in
high risk men with high grade PIN. The method of use patents issued in the United States related to
the use of toremifene for this indication that we licensed from UTRF will expire in 2019. The
method of use patents that we licensed from UTRF related to the use of toremifene for this
indication and issued outside of the United States will expire between 2019 and 2020.
We have our own method of use patents in the United States, Australia and Canada, and pending
patent applications in Japan and before the European Patent Office designating Germany, Great
Britain, Spain, France, Italy and other European Union countries, as well as pending patent
applications in certain other countries outside those regions, related to the use of toremifene 80
mg for the treatment of osteoporosis and reduction of fractures in men with prostate cancer treated
by ADT and other side effects from ADT, such as bone loss and hot flashes. Our method of use
patents issued in the United States related to the use of toremifene for the treatment of
ADT-induced osteoporosis and fractures in men with prostate cancer will expire in 2023. Our method
of use patents issued outside of the United States related to the use of toremifene 80 mg for the
treatment of osteoporosis and fractures and other side effects of ADT in men with prostate cancer
will expire in 2022. We own pending patent applications in the United States, Canada, Japan and
other countries in Asia, and pending patent applications before the European Patent Office
designating Germany, Great Britain, Spain, France, Italy and other European Union countries, as
well as pending patent applications in certain other countries outside those regions, related to
the method of use of toremifene 80 mg for the treatment of ADT-induced osteoporosis and fractures
in men with prostate cancer that, if issued, would expire between 2022 and 2025.
Even though patents have issued in respect of our owned and licensed pending method of use
patent applications, since patents covering the composition of matter of toremifene have expired,
competitors could market and sell generic versions of toremifene at doses and in formulations that
are bioequivalent to FARESTON® (toremifene citrate 60 mg) for uses other than the
indications for toremifene covered by our issued and pending method of use patent applications, and
individual physicians would be permitted to prescribe generic versions of toremifene 60 mg for
indications that are protected by our or our licensors method of use patents and pending patent
applications. Assuming toremifene receives appropriate marketing approval, if patents do not issue
in a particular country on account of our pending method of use patent applications related to the
use of toremifene 80 mg for the treatment of osteoporosis and fractures and other side effects of
ADT in men with prostate cancer, competitors may be able to market and sell generic versions of
toremifene tablets for these indications in that country.
For Ostarine and our other SARM compounds, we have an exclusive license from UTRF under its
issued patents and pending patent applications in the United States, Canada, Australia, Japan,
China and other countries in Asia, before the European Patent Office designating Germany, Great
Britain, Spain, France, Italy and other European Union countries, as well as in certain other
countries outside those regions, covering the composition of matter of the active pharmaceutical
ingredient for pharmaceutical products, pharmaceutical compositions and methods of synthesizing the
active pharmaceutical ingredients. We have also exclusively licensed from UTRF issued and pending
patent applications in the United States, Canada, Australia, Japan, China and other countries in
Asia, before the European Patent
B-1
Office designating Germany, Great Britain, Spain, France, Italy and other European Union
countries, as well as in certain other countries outside those regions, related to methods for
building muscle mass and bone in patients, for treating bone related disorders, including bone
frailty and osteoporosis, and for treating muscle wasting disorders, including cancer cachexia,
using Ostarine and other SARM compounds. The patents we licensed from UTRF and issued in the
United States for Ostarine and our other SARM compounds expire between 2021 and 2024, and the
patents we licensed from UTRF and issued outside of the United States for Ostarine expire in
2025, and with respect to other SARM compounds, expire between 2021 and 2023.
B-2