11
at nearly two hundred hospitals, and
Genzyme has previously invested $15
million in Focal for these marketing
rights. So far, Genzyme's manage-
ment has displayed smart moves and
success in developing businesses, so
let's hope it can repeat that.
Gilead Sciences (BSR #34: In-
fluenza) reported its Q1 numbers and
beat forecasts. Revenues for the quar-
ter rose 21% to just under $58 mil-
lion. Net losses were 24˘ per share,
eleven cents better than analyst esti-
mates of a loss of 35˘. Sales were
driven by the antifungal therapy Am-
Bisome. AmBisome sales were up
21% to $41.9 million.
The company
should be profitable in the not-so-
distant future from its pipeline, and
continued research should help fuel
its growth. Gilead's pipeline of drugs
remains attractive.
Gilead Sciences presented data
from four studies of adefovir
dipivoxil, its antiviral agent for the
treatment of chronic hepatitis B virus
(HBV) infection, at the 36th Annual
Meeting of the European Association
for the Study of the Liver (EASL) in
Prague, The Czech Republic. Data
from the four studies demonstrates the
efficacy, safety and resistance profile
of adefovir dipivoxil.
Currently Gilead is evaluating
adefovir dipivoxil as a monotherapy
treatment in the form of a tablet taken
once a day for chronic HBV infection.
Two pivotal multinational Phase III
clinical trials are currently underway.
Results will be released later this year,
and Gilead intends to file for regula-
tory approval in the United States and
analyze the data to gain understand-
ing prior to any decisions and an-
nouncements. It is difficult to specu-
late on the outcome.
Genentech released its first-
quarter earnings of 17˘ per share, in
line with estimates, compared with
14˘ per share in the year-ago quarter.
Revenue rose to $540.1 million from
$387.9 million last year as product
sales increased across the board.
On April 17,
Genzyme (BSR #8:
Cardiovascular) and DaVita, Inc., a
major provider of dialysis treatment
for patients with end-stage renal dis-
ease, announced the launch of a new
program to help make Renagel widely
available to patients
. This is a good
alliance enabling Genzyme to reach a
large number of people who are on
dialysis. Renagel studies have shown
excellent benefits for patients using a
phosphate binder instead of a calcium
binder.
In late April, Genzyme said it
will acquire Focal, Inc. and merge its
operations with
Genzyme Biosurgery
(
BSR #47: Wound Healing). The
merger is expected to close in the sec-
ond or third quarter of 2001. Gen-
zyme said the deal would add to the
Genzyme Biosurgery product line of
surgical materials, including gaining
worldwide rights to market FocalSeal-
L, a liquid polymer used to seal air
leaks during surgery and FocalSeal-S,
which is under development for use in
sealing the dura following brain or
spinal surgery.
Genzyme Biosurgery has mar-
keted FocalSeal-L in North America
down their inventory rather than buy-
ing new product. Cor Therapeutics
stated a narrower-than-expected 1Q
loss of 5˘ compared with the 1Q-00
loss of 19˘. Wall Street had projected
a 1Q loss of 6˘. The company reaf-
firmed 2001 earnings of 35˘ to 37˘.
April 5,
Dendreon (BSR #45:
Prostate Cancer) said it will contract
with Covance Biotechnology Services
to produce an antigen used in the
preparation of Provenge. Dendreon's
prostate cancer vaccine is currently in
Phase III clinical trials. Under the
agreement, Covance will work with
Dendreon to produce the antigen for
the commercial launch of Provenge.
Dendreon anticipates manufacturing
the therapeutic vaccine, which is a
positive sign that the clinical trials
are progressing well.
Provenge is currently in double-
blind, placebo-controlled trials taking
place at more than thirty medical cen-
ters nationwide. The trials, to involve
a total of 240 patients with hormone
refractory prostate cancer, are ex-
pected to complete patient enrollment
this year.
In late March,
Genentech (BSR #
46: Breast Cancer) reported that a
Phase III acute heart failure study of
Actelion's Veletri failed to demon-
strate improvement of symptoms of
dyspnea, or shortness of breath associ-
ated with congestive heart failure.
No
doubt a shocker for both companies
because earlier trials with published
papers indicated very positive results
of improving blood flow to and from
the heart and lessening dyspnea. The
nnext step for the companies is to
BioTech Sage Report, May 2001
