13
BioTech Sage Report, January 2000
tients with NHL. As a result, the
companies plan to initiate a Phase III
investigational clinical study for pre-
viously untreated patients with inter-
mediate- or high-grade NHL. The
phase III randomized, open-label
clinical study, is scheduled to begin in
January 2000 to evaluate the safety
and efficacy of Rituxan plus CHOP
versus CHOP alone in previously un-
treated CD20-positive intermediate-
or high-grade NHL patients. The
study will include approximately 420
patients at various sites in the US and
Canada.
Currently, Rituxan is indicated for
the treatment of patients with relapsed
or refractory, low-grade or follicular,
CD20 positive, B-cell non-Hodgkin's
lymphoma.
On December 6
th
, IDEC said more
patients with non-Hodgkins lym-
phoma responded to treatment using
its experimental cancer drug Zevalin
plus its popular drug Rituxan, than
taking Rituxan alone. In Phase III
interim results, 90 patients with cer-
tain type of non-Hodgkins lymphoma,
80 percent either went into remission
or had a 50 percent reduction in tu-
mor mass on a therapy of Zevalin and
Rituxan. That was compared to a re-
sponse rate of 44 percent of patients
taking Rituxan alone.
A related study, also reported the
results of a Phase III trial of Zevalin
in patients with follicular
non-Hodgkins lymphoma, who did
not respond or were slow to respond
to a previous treatment of Rituxan.
In the trial of patients given Zevalin
with a small pre-treatment of Rituxan,
46 percent had at least a 50 percent
reduction in tumor mass. Before the
treatment, 80 percent of these patients
had sizable tumors and 76 percent
were chemotherapy-resistant.
Immune Response (BSR #23:
Cancer Vaccines) to be replaced with
Abgenix (BSR #35: Psoriasis).
(BSR #1/#25: AIDS/Gene Therapy)
signed in October. As a result, Cell
Genesys is required to pay Genzyme a
$15 million termination fee. The Cell
Genesys board stated that the pro-
posed acquisition was not in the best
interests of Cell Genesys shareholders
primarily because the value of the
company's equity ownership of Ab-
genix Inc. had increased by approxi-
mately $230 million since the agree-
ment was announced. Cell Genesys
owns approximately 19 percent of Ab-
genix.
On December 3
rd
, Gilead (BSR
#2/#33: AIDS-related/AIDS) an-
nounced the termination of its U.S.
HIV development program for the
investigational agent adefovir
dipivoxil. This decision follows a
FDA Advisory Committee meeting on
November 1st, which the Committee
recommended against accelerated ap-
proval of adefovir dipivoxil.
On December 1
st
, IDEC (BSR
#19: Lymphoma) stockholders ap-
proved a 2-for-1 split of its common
stock.
On December 4
th
, Genentech and
IDEC announced that results from
over 90 investigational abstracts of
Rituxan, a monoclonal antibody that
was featured at the 41st Annual
American Society of Hematology
(ASH) meeting.
Two small investigational Phase II
studies evaluating the combination of
Rituxan plus CHOP cyclophospha-
mide, doxorubicin, vincristine and
prednisone) chemotherapy in patients
with CD20-positive low-grade or fol-
licular and intermediate- or high-
grade non-Hodgkin's lymphoma
(NHL) were presented. Even though
the Phase II trials were conducted in a
relatively small number of patients, it
appears that adding Rituxan to CHOP
chemotherapy may have the potential
to provide durable remissions for pa-
nounced on December 20th that they
have initiated a Phase III clinical trial
for people with moderate-to-severe
plaque psoriasis.
On December 16
th
, Genentech
announced the decision to proceed
with Phase III clinical trials studying
the company's recombinant human-
ized monoclonal antibody to Vascular
Endothelial Growth Factor (rhuMAb-
VEGF) in combination with chemo-
therapy in metastatic colorectal cancer
and metastatic non-small cell lung
cancer. The decision is based on
meeting the primary objectives in
Phase II clinical trials. Through the
Phase III trials, Genentech will have a
better understanding of the potential
safety and efficacy profile of anti-
VEGF in a larger patient population.
Genentech plans to sponsor the
Phase III trial in colorectal cancer and
is in discussions with the Eastern Co-
operative Oncology Group (ECOG) to
study rhuMAb-VEGF in conjunction
with chemotherapy in a non-small cell
lung cancer Phase III trial.
On December 2
nd
, Genentech an-
nounced FDA approval for its growth
hormone products, Nutropin and Nu-
tropin AQ for for treating young
adults with growth hormone defi-
ciency who have low bone mineral
density. Clinical data show that Nu-
tropin increased bone mineral density
at the spine, an area at risk for frac-
tures, in patients with childhood-onset
growth hormone deficiency. In the
third quarter of this year, Genentech's
sales of growth hormone products to-
taled $60.1 million.
Genentech reports 1999 earnings
target of near 90
˘
per share. The com-
pany has a five-year financial plan
calling for revenue to increase by 20-
30 percent annually and earnings per
share to grow by 25-30 percent a year.
Genzyme (BSR #8: Cardiovascu-
lar) announced on December 22
nd
,
that it has terminated the definitive
agreement to acquire Cell Genesys
