GTX, INC. 8-K
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: September 7, 2006
(Date of earliest event reported)
GTx, Inc.
(Exact name of registrant as specified in its charter)
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Delaware
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005-79588
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62-1715807 |
(State or other jurisdiction of
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(Commission
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(I.R.S. Employer |
incorporation or organization)
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File Number)
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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 registrants 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 (see General
Instruction A.2. below):
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 7.01 Regulation FD Disclosure.
On September 7, 2006, GTx publicly announced today that they have entered into a
definitive agreement under which Ipsen will have an exclusive license to develop and
market GTxs Acapodene® (toremifene citrate) in all indications except
breast cancer, in Europe (European Union, Switzerland, Norway, Iceland, Lichtenstein
and the Commonwealth of Independent States) (European Territory), a copy of which
is furnished as Exhibit 99.1 to this Current Report.
This release is furnished by GTx pursuant to Item 2.02 of Form 8-K and is not to be
considered filed under the Exchange Act, and shall not be incorporated by
reference into any previous or future filing by the Registrant under the Securities
Act or the Exchange Act.
ITEM 9.01 Financial Statements and Exhibits.
(c) Exhibits
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Exhibit |
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Description |
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99.1 |
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Press Release issued by GTx, Inc. dated September 7, 2006 |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the
Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly
authorized.
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GTx, Inc.
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Date: September 7, 2006 |
By: |
/s/ Henry P. Doggrell
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Name: |
Henry P. Doggrell |
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Title: |
Vice President, General Counsel
& Secretary |
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Ex-99.1
Exhibit 99.1
Ipsen and GTx enter into partnership agreement
for the European rights of Acapodene®
GTx conference call & webcast today at 9:00 a.m. Eastern Time
Paris (France) and Memphis, Tenn. (USA), 7 September 2006 Ipsen, a European pharmaceutical
group (Euronext: IPN) and GTx, Inc. (Nasdaq: GTXI), the Mens Health Biotech Company announced
today that they have entered into a definitive agreement under which Ipsen will have an exclusive
license to develop and market GTxs Acapodene® (toremifene citrate) in all indications
except breast cancer, in Europe (European Union, Switzerland, Norway, Iceland, Lichtenstein and the
Commonwealth of Independent States) (European Territory).
Acapodene®, a selective estrogen receptor modulator (SERM), is intended to exploit a new
strategy of estrogen receptors modulation which could translate into a tangible clinical benefit in
both the chemoprevention of prostate cancer in high-risk men and the treatment of multiple side
effects from androgen deprivation therapy in advanced prostate cancer.
Acapodene® is currently being developed in separate pivotal Phase III clinical trials
for two indications. The first indication is for the treatment of multiple side effects of androgen
deprivation therapy (ADT) for advanced prostate cancer (80 mg dose). Final data from the ADT trial
is expected in the second half of 2007 with an anticipated New Drug
Application filing in the U.S. in
2008. The second indication is for the prevention of prostate cancer in men with high grade
prostatic intraepithelial neoplasia (HGPIN)(20 mg dose). GTx expects to conduct an interim
efficacy analysis between the second half of 2007 and first quarter of 2008 for the HGPIN
indication. If the statistical parameters are achieved, GTx will proceed with the filing of a New
Drug Application in the U.S.
Ipsen will pay to GTx 23 million (approximately $30 million based on current exchange rates)
upfront payment and fees. In addition, GTx may receive milestone payments from Ipsen of 39 million
($50 million) for Acapodene®, depending on the successful development and European
launch of Acapodene® and subject to certain conditions for HGPIN: up to 9 million ($12
million) for the ADT Indication, up to 20 million ($26 million) for the HGPIN Indication and up to
10 million ($13 million) as additional milestone payments. As from execution of the agreement,
Ipsen will pay all clinical development, regulatory and launch expenses to commercialize
Acapodene® in the European Territory. Ipsen may pay a portion of GTxs
Acapodene® development costs in the U.S. if certain conditions are met. Ipsen has
agreed to pay GTx a graduating royalty on net sales in the mid-teens which could reach the
mid-twenties based on certain sales price thresholds being met. GTx is responsible for paying
upstream royalties for Acapodene®. Ipsen will procure the bulk material from
a third party and is responsible for the secondary manufacturing of the product.
We are excited to enter into a partnership with Ipsen for European rights to
Acapodene®, said Mitchell S. Steiner, M.D., Chief Executive Officer of GTx. Ipsen has
an extensive track record of drug development and commercialization in Europe and has specific
expertise marketing to urologists and oncologists. This partnership allows GTx to maintain its
rights to Acapodene® in the United States, where we will build a sales force to market
it to urologists and medical
oncologists, Steiner said. The upfront payment will add sufficient cash on our balance sheet to
last through the first quarter of 2008, which is beyond the time when we expect to see data from
both of our pivotal Phase III Acapodene® trials.
This partnership with GTx regarding Acapodene®, a product for prostate cancer
prevention and for the treatment of side effects of ADT, will further expand Ipsens franchise of
oncology products, one of our targeted therapeutic areas, said Jean-Luc Belingard, Chairman and
CEO of the Ipsen Group. It confirms Ipsens positioning in the treatment of hormone-dependent
diseases, both in oncology and endocrinology and broadens the range of our prostate cancer related
product portfolio.
Acapodene®
GTx is developing Acapodene® in two pivotal Phase III clinical trials for two separate
indications in men:
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GTx is conducting a pivotal Phase III clinical trial evaluating
Acapodene® in an 80 mg dose for the treatment of
multiple side effects of ADT for advanced prostate cancer.
Approximately 1,400 patients are participating in the trial, which
is being conducted under a Special Protocol Assessment (SPA) with
the United States Food & Drug Administration (FDA). The primary
endpoint of the trial is a reduction in vertebral fractures. Other
endpoints include improvements in Bone Mineral Density (BMD), hot
flashes, lipid profiles and gynecomastia. In December 2005, GTx
conducted a planned interim analysis of bone mineral density in
the first 197 patients to complete a full year of treatment. In
each of three measurements (lumbar spine, hip and femoral neck),
highly statistically significant positive changes in BMD were
observed in patients on Acapodene®, when compared to
patients on placebo, who on average lost bone. In June 2006, GTx
conducted a lipid interim analysis of the same 197 patients.
Patients treated with Acapodene® had statistically
significantly lower levels of total cholesterol, Low Density
Lipoproteins (LDL), and triglycerides, a reduction in the ratio of
total cholesterol to High Density Lipoproteins (HDL), and higher
HDL, when compared to patients on placebo. The full lipid data set
will be evaluated before conclusions about clinical significance
of the findings can be drawn. GTx expects to receive
final data from the trial in the second half of 2007. |
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GTx is conducting a separate pivotal Phase III clinical trial
evaluating Acapodene® in a 20 mg dose for the
prevention of prostate cancer in men with high grade PIN. More
than 1,300 patients with high grade PIN are enrolled in the trial,
which is being conducted under a SPA with the FDA. The primary
endpoint of the trial is a reduction in the incidence of prostate
cancer. GTx expects to conduct an interim efficacy analysis
between the second half of 2007 and the first quarter of 2008. If
the requisite statistical parameters are achieved, GTx will
proceed with the filing of a New Drug Application. |
About GTx, Inc.
GTx, headquartered in Memphis, Tenn., is a biopharmaceutical company dedicated to the discovery,
development and commercialization of therapeutics for cancer and serious conditions related to
mens health. GTxs lead drug discovery and development programs are focused on small molecules
that selectively modulate the effects of estrogens and androgens, two essential classes of
hormones. GTx is developing Acapodene® (toremifene citrate), a selective estrogen
receptor modulator (SERM), in two separate clinical programs in men: first, a pivotal Phase III
clinical trial for the treatment of serious side effects of ADT for advanced prostate cancer, and
second, a pivotal Phase III clinical trial for the prevention of prostate cancer in high risk men
with high grade prostatic intraepithelial neoplasia, or PIN. Orion Pharma is supplying
Acapodene® under its license and supply agreement with GTx. GTx is developing ostarine,
a
selective androgen receptor modulator, or SARM, for muscle wasting and bone loss indications.
Ostarine is currently being evaluated in a Phase II clinical trial in 120 elderly men and
postmenopausal women. GTx expects to have data from the Phase II ostarine trial in the second half
of 2006. GTx has licensed to Ortho Biotech Products, L.P., a subsidiary of Johnson & Johnson,
another of its SARMs, andarine, under a joint collaboration and license agreement.
About Ipsen
Ipsen is a European pharmaceutical group with over 20 products on the market and a total worldwide
staff of nearly 4,000. The companys development strategy is based on a combination of products in
targeted therapeutic areas (oncology, endocrinology and neuromuscular disorders), which are growth
drivers and primary care products which contribute significantly to its research financing. This
strategy is also supported by an active policy of partnerships. The location of its four R&D
centers (Paris, Boston, Barcelona and London) gives the Group a competitive edge in gaining access
to leading university research teams and highly qualified personnel. In 2005, Research and
Development expenditure reached EUR 169 million, i.e. 20.9% of consolidated sales, which amounted
to EUR 807 million in the Groups pro forma accounts set up according to the IFRS. Nearly 700
people in R&D are dedicated to the discovery and development of innovative drugs for patient care.
Ipsens shares are traded on Segment A of Eurolist by Euronext (stock code: IPN, ISIN code:
FR0010259150). Ipsens internet website is www.ipsen.com.
Ipsen in oncology
Oncology is a key driver for the future of the Ipsen Group, and is also one of its targeted
therapeutic area. Ipsens leading product, Decapeptyl®, a GnRH analogue used in androgen
deprivation therapy for prostate cancer, had 2005 sales of 211 million. Ipsens technology
programmes in peptide and protein engineering and medicinal chemistry enable it to explore and
develop new approaches in cancer treatment under hormonal control, e.g. like with steroids, growth
factors and enzymes regulating cell cycle. For instance:
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Decapeptyl®, a decapeptide analogue of GnRH, a hormone
secreted by the hypothalamus, paradoxically act as castration
agent in diseases induced by sexual hormones. Decapeptyl®
is marketed in monthly or quarterly sustained release
formulations, as well as in a daily formulation. Ipsen is
developing sustained-release formulations of Decapeptyl®
for treatment durations longer than three months and is
conducting phase III clinical trials with this product in
combination with an aromatase inhibitor in the treatment of breast
cancer in premenopausal women. |
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BN 83495, a first in class steroid sulfatase inhibitor, is tested
in a phase I trial in the treatment of postmenopausal women with
breast cancer. |
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BN 2629, a DNA minor groove binding agent, is being studied in 3
phase I trials in patients with metastatic refractory solid
tumours and leukemias. |
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Two patented cytotoxic agents, diflomotecan and elomotecan are
respectively in phase II and I clinical trials are being tested in
metastatic cancers. |
Forward-Looking Information is Subject to Risk and Uncertainty (GTx)
This press release contains forward-looking statements based upon GTxs current expectations.
Forward-looking statements involve risks and uncertainties. GTxs actual results and the timing of
events could differ materially from those anticipated in such forward-looking statements as a
result of these risks and uncertainties, which include, without limitation, the risks that (i) GTx
will not be able to commercialize its product candidates if clinical trials do not demonstrate
safety and efficacy in humans; (ii) GTx may not able to obtain required regulatory approvals to
commercialize its product candidates; (iii) GTxs clinical trials may not be completed on
schedule, or at all, or may otherwise be suspended or terminated; and (iv) GTx could utilize its
available cash resources sooner than it currently expects and may be unable to raise capital when
needed, which would force GTx to delay, reduce or eliminate its product development programs or
commercialization efforts. You should not place undue reliance on these forward-looking statements,
which apply only as of the date of this press release. GTxs
quarterly report on Form 10-Q filed with
the U.S. Securities and Exchange Commission on August 9, 2006, contains a more comprehensive
description of these and other risks to which GTx is subject. GTx expressly disclaims any
obligation or undertaking to release publicly any updates or revisions to any forward-looking
statements contained herein to reflect any change in its expectations with regard thereto or any
change in events, conditions or circumstances on which any such statements are based.
Forward-looking statements (Ipsen)
The forward-looking statements and targets contained herein are based on Ipsens managements
current views and assumptions. Such statements involve known and unknown risks and uncertainties
that may cause actual results, performance or events to differ materially from those anticipated
herein.
Ipsen expressly disclaims any obligation or undertaking to update or revise any forward-looking
statements, targets or estimates contained in this press release to reflect any change in events,
conditions, assumptions or circumstances on which any such statements are based unless so required
by applicable law. Ipsens business is subject to the risk factors outlined in its information
documents filed with the French Autorité des marchés financiers.
Conference Call Information
GTx will host a conference call & webcast today at 9:00 a.m. Eastern Time. To listen to the
conference call, please dial:
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800-659-2037 from the United States and Canada or |
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617-614-2713 (International)
The access code for the call is 47021236. |
A playback of the call will be available beginning today at 11:00 a.m., Eastern Time through
September 21, and may be accessed by dialing:
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888-286-8010 from the United States and Canada or |
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617-801-6888 (International)
The reservation number for the replay is 28701566. |
Additionally, you may access the live and subsequently archived webcast of the conference call from
the Investor Relations section of GTxs website at http://www.gtxinc.com.
For further information:
GTx, Inc.
McDavid Stilwell, Manager, Corporate Communications & Financial Analysis
Tel.: +1 901-523-9700 Fax: +1 901-844-8075 e-mail: mstilwell@gtxinc.com
Ipsen
Didier Véron, Director of Public Affairs and Corporate Communications
Tel.: +33 (0)1 44 30 42 38 Fax: +33 (0)1 44 30 42 04 e-mail: didier.veron@ipsen.com
David Schilansky, Investor Relations Officer
Tel.: +33 (0)1 44 30 43 88 Fax: +33 (0)1 44 30 43 21 e-mail: david.schilansky@ipsen.com