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Ipsen and GTx Enter into Partnership Agreement for The European Rights of Acapodene(R); GTx Conference Call & Webcast Today at 9:00 a.m. Eastern Time



    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.