GENEVA, May 17 /PRNewswire-FirstCall/ -- Serono (virt-x: SEO and NYSE:
SRA) and NovImmune (private) have signed an exclusive agreement under which
NovImmune has granted Serono exclusive worldwide rights to develop and
commercialize two of NovImmune's fully human monoclonal antibodies, NI-0401
and NI-0501, which may have therapeutic potential in a broad range of
autoimmune diseases:
    - NI-0401 targets the CD3 antigen, a key regulator in the activation of
T-cells. The proliferation of activated T-cells is a hallmark of many
autoimmune diseases, including insulin-dependent diabetes, Crohn's disease,
multiple sclerosis and rheumatoid arthritis, and of organ transplant
rejection.
    - NI-0501 targets interferon-gamma, a key cytokine involved in the
regulation of immune and inflammatory responses. Interferon-gamma is
overexpressed in autoimmune diseases such as systemic lupus erythematosus,
Crohn's disease and several forms of vasculitis.
    NI-0401 and NI-0501 are currently in preclinical development. NI-0401 is
expected to enter clinical trials later this year.
    Under the terms of the agreement, NovImmune is responsible for the
development of the two products until the completion of Phase IIa clinical
trials, after which Serono will take over further development. Serono will
pay a license fee of $5 million for the two products, make a CHF 7.5 million
equity investment in NovImmune, and lend NovImmune up to CHF 7.5 million,
convertible into shares of NovImmune on certain conditions or repayable with
accrued interest at maturity. Based on the successful development and initial
registration of the products, NovImmune may receive up to $105 million in
future milestone payments. In addition, NovImmune may receive further
milestone payments based on approval of the products for additional
indications, and will also be entitled to receive undisclosed royalties based
on eventual net sales of the products.
    "NovImmune is proud of this alliance as it represents a recognition of
the quality and clinical relevance of these products. Our products can profit
from Serono's expertise in development and marketing across multiple
indications to maximize their full potential," declared Jack Barbut,
NovImmune's CEO. "More specifically, NI-0401, which should enter the clinic
later this year, addresses a basic mechanism of the immune response and could
be efficacious in treating numerous different immune related diseases."
    "NovImmune has used state-of-the-art technologies to design antibodies
with very distinctive properties," said Tim Wells, Head of Research at
Serono. "We expect that NI-0401 and NI-0501 will have significant advantages
over precedent molecules and that those advantages will translate into
greater therapeutic potential for the treatment of chronic autoimmune
disorders."
    For Serono
    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 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).
    About NovImmune
    NovImmune is a Geneva-based product development company focusing on
immune mechanisms in order to clinically impact Immune Related Diseases,
Inflammation and Organ transplantation. NovImmune develops fully human
monoclonal antibodies, based on its direct access to both the transgenic
mouse lines and antibody display technology. NovImmune has a strategic
partnership for GMP production with Lonza Biologics. In addition, NovImmune
is developing a new class of immunosuppressors and anti-inflammatory agents
as low molecular weight inhibitors of MHC Class II expression, directed
against highly specific and totally validated protein targets. NovImmune's
first product NI-0401 is expected to enter clinical trials in Q4 2005.
    http://www.serono.com
    http://www.seronousa.com
    http://www.novimmune.com

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