Serono and NovImmune to Collaborate in Development of Two Novel Treatments for Autoimmune Diseases
May 17 2005 - 2:00AM
PR Newswire (US)
Serono and NovImmune to Collaborate in Development of Two Novel
Treatments for Autoimmune Diseases 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/ DATASOURCE:
Serono International S.A. CONTACT: Serono, Corporate Media,
Relations, Tel: +41-22-739-36-00, Fax: +41-22-739-30-85; Corporate
Investor Relations, Tel: +41-22-739-36-01, Fax: +41-22-739-30-22;
Media Relations, USA Tel: +1-781-681-2340, Fax: +1-781-681-2935,
Investor Relations, USA, Tel: +1-781-681-2552, Fax:
+1-781-681-2912; NovImmune SA, Tel: +41-22-839-41-01, Fax:
+41-22-839-41-02
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