10
Biogen (BSR #35: Psoriasis) at-
tributed its record revenue of $237
million, up from $216.8 million in the
year-ago quarter, to the strong sales of
Avonex. Earnings rose to 47˘ per
share from 41˘ per share last year
in line with estimates and despite low-
ered royalties.
Biogen's management
has proven that its marketing efforts,
supported by solid efficacy results
and Avonex's brand appeal, have
staying power with current patients,
along with the ability to draw new
patients. Biogen projects earnings to
be in line with $1.90, and with new
drugs under development, BSR main-
tains buying on the dips.
Celgene (BSR #39: Cancer
Phase III) reported first-quarter re-
sults as a breakeven, as compared to
consensus estimates of a loss of 2˘.
Revenue was $22.4 million, up from
$14.5 million in the first-quarter of
2000, an increase of 54%. The major-
ity of the income was derived from the
$17 million in sales of Thalomid,
which represents an increase of 46%
for the drug over the first quarter of
2000. Comparing year- to-year quar-
ters, Thalomid's sales show tremen-
dous growth, but comparing Q4-00 to
Q1-01, sales are flat. It appears that
sales of Thalomid (remember, Thalo-
mid is used off-labeled) have peaked,
and to rejuvenate Thalomid's growth
will require FDA approval for other
cancer indications. Celgene's man-
agement is under pressure to get data
to support Thalomid's therapeutic
benefits for other cancer types. Mean-
while, Attenade is coming into play,
and Wall Street may change its focus
and concentrate on that news, so Cel
gene's shares may get a lift.
On April 26, Celgene presented
data at a scientific conference on two
classes of compounds, cytokine in-
hibitor platform selcids and the JNK
inhibitors that demonstrate potent and
selective anti-inflammatory effects for
the treatment of immune and inflam-
matory diseases. The data on the new
selcids compounds show minimal side
effects on animal models, while data
on the JNK inhibitors confirmed the
importance of this pathway in control-
ling immunoinflammatory events in
animal models of arthritis as well as
other inflammatory diseases. Celgene
intends to file an investigational new
drug application for a novel JNK in-
hibitor within the next year.
April 3, Celgene announced that
the Arkansas Cancer Research Cen-
ter, the National Cancer Institute and
an independent data monitoring board
have conducted an interim analysis on
the safety and efficacy of the Total
Therapy II combination multiple mye-
loma trial, and will allow the study to
continue through its intended course
of treatment. To preserve the integrity
of the trial, the data safety monitoring
board has elected not to allow the re-
lease of the unblinded data. There
were no safety issues. Based on the
blinded results, the ACRC has de-
cided to enroll an additional three
hundred patients in the trial.
With an
additional 300 patients enrolled in its
clinical trials, the company will not
be able to file its supplemental NDA
by midyear, nor will the company be
able to present its data for multiple
myeloma at upcoming spring confer-
ences.
April 17,
Cell Genesys (BSR
#25: Gene Therapy) initiated clinical
trials of a GVAX prostate cancer vac-
cine following encouraging Phase II
clinical data recently reported for its
first-generation product. This new
high-potency vaccine will be tested in
prostate cancer patients who have
failed standard hormone therapy. The
series of trials to evaluate safety and
efficacy and to explore various treat-
ment regimens, is anticipated to in-
volve a total of approximately forty to
sixty patients, and will include an
evaluation of GVAX prostate cancer
vaccine in combination with chemo-
therapy. These trials will be con-
ducted at multiple centers in the
United States and are designed to pro-
vide clinical data to support the initia-
tion of a Phase III trial, which is tar-
geted for late 2002.
Additional Phase II data from the
company's ongoing GVAX prostate
cancer vaccine studies are expected to
be presented at the American Society
of Clinical Oncology Conference in
May 2001.
On April 25,
Chiron (BSR #1:
AIDS) announced that the Health
Canada's Bureau of Biologics and Ra-
diopharmaceuticals has approved
Menjugate for vaccinating all age
groups, including infants from two
months of age through adults, for pre-
vention of meningococcal C disease
.
There were no surprises on
Cor
Therapeutics' (BSR #9: Cardiovas-
cular)
first-quarter results. A few
weeks ago, the company warned that
Integrilin sales were going to be lower
because wholesalers were selling
BioTech Sage Report, May 2001
