CARLSBAD, California and GENEVA, Switzerland, October 2
/PRNewswire-FirstCall/ -- Micromet, Inc. (NASDAQ: MITI), a
biopharmaceutical company focusing on the development of novel, proprietary
antibody-based products for cancer, inflammatory and autoimmune diseases,
and Serono (virt-x: SEO and NYSE: SRA) today reported on the outcome of two
phase II trials testing the activity of adecatumumab (MT201) in metastatic
breast cancer and in prostate cancer, respectively. Adecatumumab originated
at Micromet and is developed in collaboration between Micromet and Serono.
The product candidate, a fully human monoclonal antibody targeting tumor
cells overexpressing the epithelial cell adhesion molecule (EpCAM), was
assessed as a single agent for efficacy and safety in patients with
EpCAM-positive metastatic breast cancer (N=109) and in patients with
prostate cancer (N=84). The studies tested adecatumumab at two dose levels
in patients with high and low EpCAM expression. The results suggested dose
dependent activity of adecatumumab as well as a dependency on relevant
levels of target expression.
    Final results from a phase II trial with adecatumumab in metastatic
breast cancer were reported at the 31st Congress of the European Society of
Medical Oncology (ESMO) in Istanbul, Turkey. This randomized, open label
study was conducted in 5 European countries with 26 centers participating.
Patients were stratified according to EpCAM expression into two groups, one
with low EpCAM expression and another with high level EpCAM expression.
Each group was then randomized into two arms treated every two weeks by
intravenous infusion at either 2 mg adecatumumab per kg body weight (2
mg/kg) or at 6 mg adecatumumab per kg body weight (6 mg/kg). Patients were
treated until disease progression with full tumor assessments every 6 weeks
according to standardized RECIST criteria.
    While the primary endpoint of the study (i.e., 25 percent clinical
benefit rate at week 24) was not reached, secondary end point analysis
showed a significant prolongation of time-to-progression (TTP) in patients
treated with the higher dose of adecatumumab (p=0.0465) compared to
patients receiving the lower dose. In addition, the importance of target
presence was underscored by a trend towards increased TTP in patients
expressing high EpCAM levels as opposed to patients with low or moderate
EpCAM expression on their primary tumor tissue. Patients receiving the high
dose of adecatumumab and expressing high EpCAM (high/high) on their tumor
tissue had a significantly longer TTP compared to patients with low EpCAM
on their tumor tissue and treated with the low dose of adecatumumab
(low/low) (p=0.0057). Progression-free survival was 336 days, 128 days and
49 days for 10%, 25% and 50% (median) of patients in the high/high group
with those numbers being 112 days, 59 days and 42 days in the low/low
group.
    "This phase II study indicates activity of adecatumumab in metastatic
breast cancer based on progression-free survival analysis," commented the
principal investigator, Dr. Ahmad Awada, Head of the Medical Oncology Unit
at Institute Jules Bordet in Bruxelles, Belgium. "If this activity can be
confirmed in additional trials, adecatumumab may offer a treatment option
for patients with breast cancers highly overexpressing EpCAM. This finding
is important because normally this patient population is believed to have a
reduced overall survival compared to patients with low or no EpCAM
expression."
    The second trial, a placebo-controlled phase II study in relapse of
prostate cancer, used serum PSA levels as the main readout for biological
and clinical activity (n=84). The primary endpoint of this study was mean
change in PSA at week 24 compared to baseline. While the primary end point
was not reached, the analysis of the final data of the study indicated that
treatment with 6 mg/kg adecatumumab had a beneficial trend when compared to
placebo (0.46 ng/ml versus 1.24 ng/ml; p=0.0879). In a further exploration
this trend was only seen for patients having high EpCAM expression levels
(p=0.0884), but not for patients with low EpCAM expression (p=0.7947). The
patients included in this trial had a high variability of PSA at study
start (variation by a factor of 100 with baseline PSA values ranging from
0.2 to 20 ng/ml in serum). The clinical experts advising the company in
connection with this trial determined that this high variability of PSA may
have confounded the results and recommended that a retrospective sub-group
analysis of the primary endpoint should be performed in a more homogeneous
patient population. According to the experts, predominantly patients with
PSA levels £1 ng/ml at baseline would define a minimal residual disease
setting. The retrospective sub-group analysis for this specific patient
population with high EpCAM expression (n=23) showed that both high (6
mg/kg) and low adecatumumab dose (2 mg/kg) given every other week for seven
weeks led to a statistically significant smaller increase in PSA (0.38
ng/ml; p=0.0356, and 0.21 ng/ml; p=0.0014, respectively) compared to the
placebo group (0.76 ng/ml) in patients with a high EpCAM expression.
    Prof. Axel Heidenreich, Head of the Urological Clinic at the University
Hospital of Cologne, Germany, commented:"While the primary end point was
not reached likely due to high inter-patient variability of PSA, the
analysis of the minimal residual disease subset showed an encouraging
effect on PSA progression, although patient numbers are limited. The fact
that these effects were seen in patients with high EpCAM expression further
validates the concept of adecatumumab being a true targeted therapy."
    Adecatumumab was generally well tolerated in both trials with the
observation of a dose-dependent incidence of adverse events (AE) in both
trials. The most frequent AE were fever, chills, diarrhea, hypertension,
lymphopenia, and elevation of pancreatic enzymes, and most AE were of mild
to moderate severity.
    The partners continue to investigate opportunities for further
development. Adecatumumab is being explored for tolerability in combination
with docetaxel in an ongoing phase Ib study in Europe. The information from
the current trials will be used to further refine the targeted patient
populations and dosing regimens as well as to explore other solid tumor
settings.
    Background material
    For free B-roll, video and other content for Serono and its products,
please visit the Serono Media Center http://www.thenewsmarket.com/Serono. You can
download print-quality images and receive broadcast-standard video
digitally or by tape from this site. Registration and video is free to the
media.
    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 and autoimmune diseases.
    In 2005, Serono, whose products are sold in over 90 countries, achieved
worldwide revenues of US$2,586.4 million. Reported net loss in 2005 was
US$106.1 million, reflecting a charge of US$725 million taken relating to
the settlement of the US Attorney's Office investigation of Serostim.
Excluding this charge as well as other non-recurring items, adjusted net
income grew 28.4% to US$565.3 million in 2005. 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 Micromet, Inc. (http://www.micromet-inc.com)
    Micromet, Inc. is a biopharmaceutical company focusing on the
development of novel, proprietary antibody-based products for cancer,
inflammatory and autoimmune diseases. Two product candidates are currently
in clinical trials. For adecatumumab (MT201), a recombinant human
monoclonal antibody, two Phase 2 clinical trials for the treatment of
patients with breast cancer and prostate cancer have been completed in Q3
2006. MT103 (MEDI-538), a BiTE(r) product candidate, is being studied in a
Phase 1 clinical trial for the treatment of patients with Non Hodgkin
Lymphoma. Micromet has established a drug development platform based on its
BiTE(r) technology, a unique, antibody-based format that leverages the
cytotoxic potential of T cells, the most powerful 'killer cells' of the
human immune system. Micromet has established collaborations with
MedImmune, Inc. and Serono.
    Forward-Looking Statements
    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 February 28, 2006. 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 any government
investigations and litigation. Serono is providing this information as of
the date of this press release, and 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.
    For Micromet:
    This release contains certain forward-looking statements that involve
risks and uncertainties that could cause actual results to be materially
different from historical results or from any future results expressed or
implied by such forward-looking statements. Such forward-looking statements
include statements regarding the company's clinical development activities;
the observation of clinical activity of MT201 in metastatic breast cancer,
based on the observed prolongation of TTP in patients treated with the
higher dose of MT201, compared to patients receiving the lower dose and the
progression -free survival rates observed in the high EpCAM / high dose
group, compared to the low EpCAM / low dose group; the potential for such
clinical activity to be confirmed in additional clinical trials; the
potential for adecatumumab to offer a treatment option for patients with
high EpCAM overexpression; the observation in the prostate cancer trial of
the potential benefit of MT201 in patients with high EpCAM expression
levels; the belief that the variability in baseline PSA for the trial
subjects may have impacted the results of the prostate cancer trial;
Micromet's and Serono's intention to continue the development of
adecatumumab for the treatment of metastatic breast cancer in combination
with docetaxel; the evaluation of other solid tumor settings for additional
development opportunities; and Micromet's and Serono's intention to
continue to explore the future development opportunities; and Micromet's
and Serono's intention to continue to explore the future development of
MT201 as a single agent in prostate cancer or breast cancer.. Factors that
may cause actual results to differ materially include the risk that product
candidates that appeared promising in early research and clinical trials do
not demonstrate safety and/or efficacy in larger-scale or later clinical
trials, the risk that encouraging results from clinical trials may not be
confirmed upon further analysis of the detailed results of a trial and
additional information relating to the safety, efficacy or tolerability of
our product candidates may be discovered upon further analysis of the trial
data, the risk that we will not obtain approval to market our product
candidates, the risks associated with reliance on outside financing to meet
capital requirements, and the risks associated with reliance on
collaborative partners, including Serono, for further clinical trials,
development and commercialization of product candidates, including MT201.
You are urged to consider statements that include the words "ongoing",
"may", "will", "would", "could", "should", "believes", "estimates",
"projects", "potential", "expects", "suggests", "plans", "anticipates",
"intends", "continues", "forecast", "designed", "goal", or the negative of
those words or other comparable words to be uncertain and forward-looking.
These factors and others are more fully discussed in our periodic reports
and other filings with the SEC.
    Any forward-looking statements are made pursuant to Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the Securities
Exchange Act of 1934, as amended, and, as such, speak only as of the date
made. Micromet, Inc. undertakes no obligation to publicly update any
forward-looking statements, whether as a result of new information, future
events or otherwise.
    For more information, please contact:

    Serono

    Corporate Media Relations:
    Tel: +41-22-739-36-00
    Fax: +41-22-739-30-85
    http://www.serono.com

    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
    http://www.seronousa.com

    Investor Relations, USA:
    Tel: +1-781-681-2552
    Fax: +1-781-681-2912

    Micromet, Inc.

    Media Europe:
    Evelyn Wolf
    +49(0)89-895277-220
    evelyn.wolf@micromet-inc.com

    Investors:
    Ines-Regina Buth
    +1-760-494-4235 (US)
    +49(0)89-895277-221 (Europe)
    ines.buth@micromet-inc.com

    Media US:
    Susan Noonan
    +1-212-966-3650
    susan@sanoonan.com

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