9
On December 4, Genentech/
NYSE: DNA (BSR #46: Breast Cancer)
and Roche announced a Phase II
study of Herceptin in combination with
Taxotere suggested improved survival
rate in breast cancer patients as a first-
line treatment for HER-2 (human epi-
dermal growth factor receptor-2) posi-
tive metastatic breast cancer patients.
The multicenter randomized Phase II
trial results suggested that adding Her-
ceptin to Taxotere resulted in an in-
crease in median survival of 51%, or
9.4 months. The overall response rate
for patients treated with Herceptin plus
Taxotere was significantly increased.
On November 25, Genentech re-
leased news about Avastin in comb i-
nation with 5-FU/Leucovorin, a non-
standard of care chemotherapy regi-
men, versus 5-FU/Leucovorin alone in
Phase II clinical trials. Although Avas-
tin did not achieve a statistical signifi-
cance in reaching its primary end-
points of increasing survival time, 29%
or 3.5 months when patients were
added to the two-drug regimen, it sig-
nificantly prolonged progression-free
survival by 67%. This data, combined
with earlier positive data in combina-
tion with a three-drug regimen,
strongly supports Avastin as a first-
line standard of care for the treatment
of metastatic colorectal cancer.
As a result, we continue to expect
FDA approval of Avastin in the first
quarter of 2004.
On December 1, Genentech and
Protein Design Labs/NASDAQ:
PDLI (BSR #18: Leukemia) announced
they have reached an agreement in
principle to resolve their dispute relat-
ing to Protein Design Lab's antibody
humanization patents and certain of
OA in both the knee and hip. Two ad-
ditional clinical trials are expected to
begin later this year in Europe to
evaluate Synvisc in treating pain due
to OA of the ankle and shoulder.
We've mentioned in the past the
pending competition with Genzyme's
Renagel from Shire's Fosrenol. A rat
toxicology study conducted by Ge n-
zyme, found significant deposits of
Fosrenol in lung, liver and brain tis-
sues after 28 days of dosing, and con-
cluded that the bone is unlikely to be
the primary target of accumulation.
Importantly, Genzyme plans to
submit this data to the FDA, in an ef-
fort to combat potential approval and
competition from Fosrenol.
However, Amgen's Cinacalcet
could affect Genzyme's Renagel sales
once Cinacalcet reaches the market.
Cinacalcet will reduce the average
dose of Renagel, and could have a
modestly negative effect on the num-
ber of patients on Renagel. (Cinacalcet
causes a decline in phosphorous lev-
els permitting a lower required dose of
Renagel in patients receiving both Re-
nagel and Cinacalcet. In addition, by
reducing calcium levels and the need
for Vitamin D, Cinacalcet may allow for
a greater number of patients to use
calcium-based phosphate binders, at
the expense of Renagel.) However, the
effect is unlikely to be material until at
least 2005 when the number of patients
receiving Cinacalcet rises to a mean-
ingful level, and a Medicare drug bene-
fit would more than offset any lost
revenues by providing increased reim-
bursement for Genzyme.
On November 25, Gilead Science/
NASDAQ: GILD (BSR #37: Hepatitis
Genentech's humanized antibodies.
Under the patent licensing master
agreement, Genentech will share prof-
its from the asthma drug Xolair and
two other cancer drugs, Raptiva and
Avastin. Under the proposed agree-
ment, Genentech will agree to pay a
royalty, though less than Protein De-
sign had originally desired, on Xolair
and on the psoriasis drug Raptiva and
the experimental cancer drug Avastin.
The news is good, as Genentech had
been contesting the claim that patents
Protein Design Labs holds on early
stages of the technology used to pro-
duce the drugs were valid. Now
Genentech has recognized Protein De-
sign Labs' claim. The companies said
they are working to conclude a defini-
tive settlement arrangement by the end
of December 2003.
On November 24, Genzyme/
NASDAQ: GENZ (BSR #8: Cardio-
vascular) announced it has begun pa-
tient treatment in its pivotal clinical
trial using Synvisc to treat pain due to
osteoarthritis (OA) of the hip. The
clinical trial will enroll 300 patients at
30 study centers across the U.S. The
primary objective of the study is to
determine efficacy and safety of two
intra-articular Synvisc injections in
treating patients with mild to moderate
primary OA of the hip. If the results are
positive for pain relief, Genzyme ex-
pects to use the data to broaden the U.
S. label for Synvisc to include treat-
ment of pain due to hip OA. There is a
large market opportunity to expand
Synvisc into other joints beyond the
knee.
Synvisc is currently approved in
Europe and Canada to treat pain due to
BioTech Stock Report, January 2004
