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BioTech Stock Report, January 2004
data from the Eastern Cooperative On-
cology Group (ECOG) study 4494,
which described Rituxan plus chemo-
therapy as an induction therapy fol-
lowed by Rituxan alone as mainte-
nance therapy in newly diagnosed ag-
gressive NHL. The results from the
study demonstrated a statistically sig-
nificant improvement in time to treat-
ment failure for patients receiving Ri-
tuxan and chemotherapy compared to
chemotherapy alone.
What was called into question
was the use of Rituxan alone for main-
tenance therapy for aggressive NHL,
which was another component of the
study. We had hoped to see some evi-
dence of a trend toward improved sur-
vival for the inclusion of Rituxan in the
maintenance arm following Rituxan and
chemotherapy induction. Unfortu-
nately, none was observed. This was
disappointing, as the investigators had
hoped Rituxan in maintenance therapy
would improve patient survival.
Studies involving Rituxan in indo-
lent NHL were supporting continued
use in conjunction with chemotherapy.
In one study 321 patients, not previ-
ously treated, with stage III/IV indo-
lent lymphoma were randomized to
receive cyclophosphamide, vincristine
and prednisone (CVP) chemotherapy
on a 21 day cycle for eight cycles with
Rituxan (375 mg/m2) on the first day of
each cycle (n=162) or without Rituxan
(n=159). The primary endpoint of the
study was time to treatment failure de-
fined as the risk of disease progres-
sion, relapse, death or stable disease
growth. The merger between Biogen
and Idec, in our opinion, was a cost
saving move for both companies, but
the new entity is still faced with the
issues of slowed growth and limited
pipeline. The company's main drivers
are Rituxan, Zevalin for NHL, Amevive
for psoriasis and Avonex for multiple
sclerosis (MS). Unfortunately, in-
creased competition for psoriasis and
MS is eroding the company's market
share, which is leading to the slowed
growth. Antegren, the company's most
advanced product in development for
MS is faced with questions regarding
safety and efficacy, so we doubt Ante-
gren will be approved anytime in the
near future. Biogen-Idec had hoped
Antegren would receive approval from
the FDA market.
The other hot topic at ASH was
multiple myeloma (MM). We covered
MM in June and the main story at that
time was Millennium's (NASDAQ:
MLNM) novel proteasome inhibitor,
Velcade that had received FDA ap-
proval for treating patients with refrac-
tory/relapsing MM. Use of Velcade in
MM is gaining momentum in the clin-
ics and the data presented at the meet-
ing regarding a Phase I/II clinical trial
with Velcade as a front-line therapy for
MM was encouraging. The data
showed the effectiveness of the prod-
uct in this setting with some added
benefit demonstrated in combination
with dexamethasone. The primary side
effect was peripheral neuropathy,
which is commonly observed with Ve l-
cade treatment. The study is continu-
ing patient accrual with a target enroll-
after four cycles of treatment or on the
administration of a new treatment. The
overall response rate was 57% for the
CVP arm versus 81% for Rituxan and
CVP while the time to treatment failure
primary endpoint was 7 months for
CVP and 26 months on Rituxan-CVP.
The results of the study show strong
support for the addition of Rituxan to
the treatment regimen in the frontline
setting.
Based upon these results and oth-
ers presented at the meeting what do
we conclude? As we have said in the
past, we like Rituxan and believe it will
remain a major component for all NHL
treatments. We acknowledge that there
will remain cases where Rituxan will
not be a benefit to the patient, but out
of the more than 300,000 people in the
U.S. with B-cell lymphoma, half are
patients with aggressive NHL, which
represents a significant patient popula-
tion for Rituxan. The other half are
those patients with indolent or follicu-
lar lymphoma, who are already prime
candidates for Rituxan therapy.
What's more supportive for Rituxan is
that NHL is the second fastest grow-
ing cancer in terms of incidence and
deaths in the U.S. and is diagnosed in
more than 56,000 men and women each
year. We believe physicians will con-
tinue to prescribe Rituxan for NHL, and
that sales will continue to increase and
be the primary driver for growth, spe-
cifically for Biogen-Idec.
So, does this mean we recommend
investors buy Biogen-Idec? Not nec-
essarily, if investors are looking for
