UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): December 7, 2006
GTx, Inc.
(Exact name of registrant as specified in its charter)
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| Delaware
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000-50549
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62-1715807 |
(State or other jurisdiction of
incorporation or organization)
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(Commission
File Number)
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(I.R.S. Employer
Identification No.) |
3 N. Dunlap Street
3rd
Floor, Van Vleet Building
Memphis, Tennessee 38163
(901) 523-9700
(Address, including zip
code, and telephone number,
including area code, of registrant’s principal executive offices)
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy
the filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
TABLE OF CONTENTS
ITEM 1.02 Termination of a Material Definitive Agreement
On December 7, 2006, GTx, Inc. (“GTx”) and Ortho Biotech Products, L.P., a subsidiary of
Johnson & Johnson (“Ortho Biotech”), mutually agreed to terminate the Joint Collaboration and
License Agreement, dated March 16, 2004, by and between GTx and Ortho Biotech (the “Collaboration
Agreement”). Pursuant to the terms of the Collaboration Agreement, GTx and Ortho Biotech had agreed
to jointly develop and commercialize andarine, a selective androgen receptor modulator (“SARM”),
for indications related to men’s health and other licensed SARM compounds meeting specified
criteria that Ortho Biotech may have ultimately chosen to develop instead of, or in addition to,
andarine. Pursuant to the terms of the Collaboration Agreement, GTx received an up-front licensing
fee and reimbursement of certain andarine development expenses totaling approximately $6.7 million,
which was being amortized into revenue over five years. In the fourth quarter 2006, GTx expects to
recognize collaboration revenue of approximately $3.3 million, which represents the unamortized
balance of the up-front licensing fee paid by Ortho Biotech to GTx. Under the Collaboration
Agreement, GTx was entitled to receive additional licensing fees and milestone payments prior to
product launch of (1) up to an aggregate of $76.0 million for licensed products containing andarine
or any replacement compound, and (2) up to $45.0 million for each licensed product containing any
other compound developed under the Collaboration Agreement, upon achievement of specific clinical
development milestones or receipt of regulatory approvals. Ortho Biotech was also obligated under
the Collaboration Agreement to pay GTx up to double digit royalties on worldwide net sales of
andarine and other licensed products, and an additional royalty in excess of 20% on all co-promoted
net sales to urologists in the United States. As a result of the termination of the Collaboration
Agreement, GTx does not expect to receive or record any portion of these additional licensing fees,
milestone payments or royalties. Under the Collaboration Agreement, Ortho Biotech was responsible
for the manufacture, packaging and supply of andarine for both clinical trials and
commercialization.
The above description of the Collaboration Agreement is a summary of certain of the material
terms of the Collaboration Agreement and does not purport to be complete, and is qualified in its
entirety by reference to the Collaboration Agreement, which was filed as Exhibit 10.24 to GTx’s
Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission on May 7, 2004.
ITEM 8.01 Other Events.
On December 8, 2006, GTx, Inc. issued a press release announcing positive Phase II clinical
trial results for ostarine, a SARM, and announcing that it has reacquired full rights to develop
and commercialize andarine and all backup compounds previously licensed to Ortho Biotech under the
Collaboration Agreement. A copy of the press release is attached as Exhibit 99.1 to this current
report and is incorporated herein by reference.
ITEM 9.01 Financial Statements and Exhibits.
(d)
Exhibits
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Description |
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99.1 |
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Press Release issued by GTx, Inc. dated December 8, 2006 |