Ipsen, a European pharmaceutical group (Paris: IPN) and
GTx, Inc. (Nasdaq: GTXI), the Men's 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 GTx's
Acapodene(R) (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(R), 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(R) 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 US 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 US.
Ipsen will pay to GTx EUR 23 million (approximately $30 million
based on current exchange rates) upfront payment and fees. In
addition, GTx may receive milestone payments from Ipsen of EUR 39
million ($50 million) for Acapodene(R), depending on the successful
development and European launch of Acapodene(R) and subject to certain
conditions for HGPIN: up to EUR 9 million ($12 million) for the ADT
Indication, up to EUR 20 million ($26 million) for the HGPIN
Indication and up to EUR 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(R) in the European Territory. Ipsen may pay a
portion of GTx's Acapodene(R) 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(R). 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(R)," 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(R) 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(R) trials."
"This partnership with GTx regarding Acapodene(R), a product for
prostate cancer prevention and for the treatment of side effects of
ADT, will further expand Ipsen's franchise of oncology products, one
of our targeted therapeutic areas," said Jean-Luc Belingard, Chairman
and CEO of the Ipsen Group. "It confirms Ipsen's 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(R)
GTx is developing Acapodene(R) in two pivotal Phase III clinical
trials for two separate indications in men:
-- GTx is conducting a pivotal Phase III clinical trial
evaluating Acapodene(R) 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(R), 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(R) 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.
-- GTx is conducting a separate pivotal Phase III clinical trial
evaluating Acapodene(R) 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 men's
health. GTx's 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(R) (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(R) 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 company's
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 Group's
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. Ipsen's shares are traded on Segment A of Eurolist
by Euronext (stock code: IPN, ISIN code: FR0010259150). Ipsen's
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. Ipsen's leading product,
Decapeptyl(R), a GnRH analogue used in androgen deprivation therapy
for prostate cancer, had 2005 sales of EUR 211 million. Ipsen's
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:
-- Decapeptyl(R), a decapeptide analogue of GnRH, a hormone
secreted by the hypothalamus, paradoxically act as castration
agent in diseases induced by sexual hormones. Decapeptyl(R) is
marketed in monthly or quarterly sustained release
formulations, as well as in a daily formulation. Ipsen is
developing sustained-release formulations of Decapeptyl(R) 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.
-- 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.
-- 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.
-- 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
GTx's current expectations. Forward-looking statements involve risks
and uncertainties. GTx's 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) GTx's 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. GTx's annual report on form
10-Q filed with the U.S. Securities and Exchange Commission on 5 May
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 Ipsen's management's 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. Ipsen's business is
subject to the risk factors outlined in its information documents
filed with the French Autorite des marches 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:
-- 800-659-2037 from the United States and Canada or
-- 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 21 September, and may be accessed by
dialing:
-- 888-286-8010 from the United States and Canada or
-- 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
GTx's website at http://www.gtxinc.com.
