HuMax-CD4 Currently in Phase III Clinical Trial for Cutaneous T-Cell
Lymphoma and Phase II Clinical Trial for Non-Cutaneous T-Cell Lymphoma

    GENEVA, Switzerland and COPENHAGEN, Denmark, August 18
/PRNewswire-FirstCall/ -- Serono (virt-x: SEO and NYSE: SRA) and Genmab A/S
(CSE: GEN) announced today an agreement under which Genmab has granted Serono
exclusive worldwide rights to develop and commercialize Genmab's HuMax-CD4.
HuMax-CD4 is a fully human monoclonal antibody in development for the
treatment of cutaneous and non-cutaneous T-cell lymphomas. It is currently
being evaluated in a pivotal Phase III clinical trial for cutaneous T-cell
lymphoma (CTCL) under the US Food and Drug Administration's Special Protocol
Assessment process and has Fast Track designation from the FDA. HuMax-CD4 is
also being studied in a Phase II trial for non-cutaneous T-cell lymphoma
(NCTCL). HuMax-CD4 is directed against the CD4 antigen and causes depletion
of certain T-cells through antibody-dependent cellular cytotoxicity.
    Under the terms of the agreement, Genmab will receive a license fee of
USD 20 million, and Serono will make a USD 50 million investment in Genmab
common stock, at a premium to the market price. Genmab may receive up to USD
215 million in total payments, including the initial license fee and equity
purchase, milestone payments for regulatory submissions and approvals of
HuMax-CD4 in CTCL and NCTCL in the US, Europe and Japan, and payments based
on the achievement of certain sales milestones. Genmab will be entitled to
receive royalties on global sales of HuMax-CD4. Serono will be responsible
for all future development costs for HuMax-CD4 and for future manufacturing
of the product. Genmab will continue to conduct the ongoing clinical trials
as described above.
    "Serono's proficiency in bringing biotechnology products to market as
well as their established presence in highly specialized dermatology clinics,
which play a significant role in the diagnosis and treatment of CTCL, makes
the company an excellent strategic partner," said Lisa N. Drakeman, Ph.D.,
Chief Executive Officer of Genmab.
    "We are committed to building a strong oncology pipeline through
partnerships with leading companies such as Genmab, and through our own
internal research," said Ernesto Bertarelli, Chief Executive Officer of
Serono. "HuMax-CD4 is an important addition to Serono's oncology portfolio,
which now consists of four different clinical-stage products being
investigated across a broad range of indications."
    Simultaneously with this release, Genmab will publish a separate stock
exchange release containing more information regarding the placement of
Genmab shares to Serono, which is made in direct connection with the Global
Development and Commercialization Agreement regarding HuMax-CD4.
    About CTCL and NCTCL
    Cutaneous T-cell lymphomas (CTCL) are a group of lymphomas characterized
by abnormal accumulation of malignant T-cells in the skin, potentially
resulting in the development of rashes, plaques and tumors. The most common
types of CTCL include mycosis fungoides (MF) and Sezary syndrome (SS). CTCL
result from errors in the production of T-lymphocytes or transformation of
T-lymphocytes into malignant cells. Abnormal, uncontrolled growth and
multiplication of malignant T-lymphocytes result in accumulation of these
lymphocytes in the skin and may in some cases spread and affect the lymph
nodes and other body tissues and organs, resulting in life-threatening
complications.
    Non-cutaneous T-cell lymphomas (NCTCL) are defined by highly malignant
disease, which has localized to the lymph nodes even at the earliest stage of
presentation, and include angioimmunoblastic T-cell lymphoma, anaplastic
large cell lymphoma (ALCL) and unspecified peripheral T-cell lymphoma. NCTCL
is characterized by aggressive progression with average survival time of
approximately two years.
    About HuMax-CD4 (Zanolimumab)
    HuMax-CD4 is a human monoclonal antibody currently in Phase III
development for cutaneous T-cell lymphoma (CTCL) and in Phase II for
non-cutaneous T-cell lymphoma. These types of lymphomas express the CD4
receptor, which is the target of HuMax-CD4. In April 2005, Genmab and the
United States Food and Drug Administration (FDA) reached an agreement on the
design of its pivotal study protocol for HuMax-CD4 to treat CTCL under the
Special Protocol Assessment process (SPA). The pivotal study will include
patients with mycosis fungoides (MF) who are refractory to or intolerant of
Targretin(R) and one other standard therapy, and will treat a total of 88
patients.
    In March 2004, Genmab announced that HuMax-CD4 had been designated a Fast
Track Product by the US Food and Drug Administration (FDA). This designation
covers patients with CTCL for whom no available therapy exists, i.e. have
failed at least two systemic treatment regimens. HuMax-CD4 for the treatment
of MF has also been granted Orphan Drug status in the US and Europe.
    Genmab forward-looking statements
    This press release contains forward-looking statements. The words
"believe", "expect", "anticipate", "intend" and "plan" and similar
expressions identify forward looking statements. Actual results or
performance may differ materially from any future results or performance
expressed or implied by such statements. The important factors that could
cause our actual results or performance to differ materially include, among
others, risks associated with product discovery and development,
uncertainties related to the outcome and conduct of clinical trials including
unforeseen safety issues, uncertainties related to product manufacturing, the
lack of market acceptance of our products, our inability to manage growth,
the competitive environment in relation to our business area and markets, our
inability to attract and retain suitably qualified personnel, the
unenforceability or lack of protection of our patents and proprietary rights,
our relationships with affiliated entities, changes and developments in
technology which may render our products obsolete, and other factors. Genmab
is not under an obligation to up-date statements regarding the future
following the publication of this release; nor to confirm such statements in
relation to actual results, unless this is required by law.
    Serono forward-looking statements
    Some of the statements in this press release are forward looking. Such
statements are inherently subject to known and unknown risks, uncertainties
and other factors that may cause actual results, performance or achievements
of Serono S.A. and affiliates to be materially different from those expected
or anticipated in the forward-looking statements. Forward-looking statements
are based on Serono's current expectations and assumptions, which may be
affected by a number of factors, including those discussed in this press
release and more fully described in Serono's Annual Report on Form 20-F filed
with the U.S. Securities and Exchange Commission on March 16, 2005. These
factors include any failure or delay in Serono's ability to develop new
products, any failure to receive anticipated regulatory approvals, any
problems in commercializing current products as a result of competition or
other factors, our ability to obtain reimbursement coverage for our products,
the outcome of government investigations and litigation and government
regulations limiting our ability to sell our products. Serono has no
responsibility to update the forward-looking statements contained in this
press release to reflect events or circumstances occurring after the date of
this press release.
    About Genmab A/S
    Genmab A/S is a biotechnology company that creates and develops human
antibodies for the treatment of life-threatening and debilitating diseases.
Genmab has numerous products in development to treat cancer, infectious
disease, rheumatoid arthritis and other inflammatory conditions, and intends
to continue assembling a broad portfolio of new therapeutic products. At
present, Genmab has multiple partnerships to gain access to disease targets
and develop novel human antibodies including agreements with Roche and Amgen.
A broad alliance provides Genmab with access to Medarex, Inc.'s array of
proprietary technologies, including the UltiMAb(R) platform for the rapid
creation and development of human antibodies to virtually any disease target.
Genmab has operations in Copenhagen, Denmark, Utrecht, the Netherlands, and
Princeton, New Jersey in the US. For more information about Genmab, visit
http://www.genmab.com.
    About Serono
    Serono is a global biotechnology leader. The Company has eight
biotechnology products, Rebif(R), Gonal-f(R), Luveris(R), Ovidrel(R
)/Ovitrelle(R), Serostim(R), Saizen(R), Zorbtive(TM) and Raptiva(R). In
addition to being the world leader in reproductive health, Serono has strong
market positions in neurology, metabolism and growth and has recently entered
the psoriasis area. The Company's research programs are focused on growing
these businesses and on establishing new therapeutic areas, including
oncology. Currently, there are approximately 30 ongoing development projects.
    In 2004, Serono achieved worldwide revenues of US$2,458.1 million, and a
net income of US$494.2 million, making it the third largest biotech company
in the world. Its products are sold in over 90 countries. Bearer shares of
Serono S.A., the holding company, are traded on the virt-x (SEO) and its
American Depositary Shares are traded on the New York Stock Exchange (SRA).
    http://www.serono.com
    http://www.seronousa.com

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