GENEVA, Switzerland, April 6 /PRNewswire-FirstCall/ -- Serono (NYSE: SRA;
virt-x: SEO) announced today the discontinuation of two phase 3 clinical trial
programs; onercept (recombinant tumor necrosis factor binding protein) in
moderate-to-severe psoriasis and Canvaxin(TM) in Stage IV melanoma, licensed
from CancerVax. The decision to discontinue these clinical trials is based on
the recommendations of two separate independent Data and Safety Monitoring
Boards (DSMBs).
Onercept in moderate-to-severe psoriasis
In 2004, Serono initiated three phase 3 clinical trials in moderate-to-
severe psoriasis. Investigators have recently reported two patients diagnosed
with sepsis, one of whom subsequently died. Sepsis is a recognized potential
risk for patients treated with anti-tumor necrosis factor (TNF) therapies.
Serono convened a meeting of the independent DSMB to evaluate the available
blinded efficacy data at 12 weeks for the two placebo-controlled pivotal
trials and data from the first 12 weeks of the open-label trial. It was
determined based on these aggregate data that the efficacy response observed
for onercept was less than that observed in the earlier phase 2 trial, and
with other available treatments. As a consequence of its unfavorable risk-
benefit profile, the DSMB recommended to discontinue the clinical development
of onercept in moderate-to-severe psoriasis.
Canvaxin(TM) in Stage IV melanoma
The DSMB for Canvaxin(TM) which recently completed its planned, second
interim analysis of the data in Stage IV melanoma, recommended its
discontinuation as the data are unlikely to provide significant evidence of a
survival benefit for Canvaxin(TM)-treated patients with Stage IV melanoma
versus those receiving placebo.
With regard to the currently on-going phase 3 clinical trial of
Canvaxin(TM) in Stage III melanoma, the DSMB confirmed that this trial should
continue. The third interim analysis of the data is expected in the third
quarter of 2005. The final analysis of data from this clinical trial will take
place after the required number of clinical events will have occurred, which
is currently estimated to be around mid-2006.
"We support the recommendation of the two Data and Safety Monitoring
Boards," said Franck Latrille, Senior Executive Vice President, Corporate
Global Product Development. "We will continue to develop Canvaxin(TM) in Stage
III melanoma."
Conference Call
Serono will hold a conference call on Wednesday, April 6, 2005, starting
at 15:00 pm Central European Time (9:00 am Eastern Time) during which Serono
Management will present a statement on the discontinuation of these clinical
trials and answer questions. To join the telephone conference please dial
+1-866-291-4166 (from the US), 091-610-5600 (from Switzerland), 0207-107-0611
(from the UK) and +41-91-610-5600 (from elsewhere). Telephone playback will be
available one hour after the conference call and until 5.00 pm CET on April
15, 2005. To access this playback please dial the following numbers: 091-612-
4330 (from Switzerland), 0207-108-6233 (from the UK), +1-866-416-2558 (from
the USA) and +41-91-612-4330 (from elsewhere) and enter the PIN code 943# from
a touch tone telephone.
About the DSMB
The DSMB consists of independent experts who are not participating in the
clinical trials. Their primary responsibility is to monitor, on a periodic
basis, the data emerging from a clinical trial and to provide recommendation
to the sponsor on whether a study should continue, be modified or
discontinued.
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,
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).
http://www.serono.com
http://www.seronousa.com
Reuters: SEO.VX / SRA.N
Bloomberg: SEO VX / SRA US
SOURCE Serono International S.A.
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Related links:
http://www.serono.com
http://www.seronousa.com
CONTACT:
Corporate Media Relations: Tel:
+41-22-739-36-00, Fax: +41-22- 739-30-85; Media Relations, USA:
Tel: +1-781-681-2340, Fax: +1-781-681-2935; Corporate Investor
Relations: Tel: +41-22-739-36-01, Fax: +41-22-739-30-22; Investor
Relations, USA: Tel: +1-781-681-2552, Fax: +1-781-681-2912
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