15
rheumatoid arthritis, which will be
available beginning March 2001.
Good news for Immunex's bottom line.
On December 21,
Incyte Ge-
nomics (BSR #5: Genomics) en-
dorsed forecasts that it will have a
loss for full-year 2000 in the range of
the high $20s to the low $30s
(million) with revenues between $190
million and $199 million for 2000. In
addition, Incyte purchased privately
held Massachusetts genomics firm
Proteome Inc. for $77 million in cash
and stock.
Proteome owns a database with
information on the genes of human,
rat, mouse, worm, yeast and other or-
ganisms used in medical research.
Because human genes are similar or
sometimes identical to those of vari-
ous research organisms, scientists can
identify causes of human disease by
first locating disease-related genes in
other species.
It should be a good
move for Incyte to enhance its prod-
uct mix and to stay competitive.
December 14, the FDA advisory
committee recommended accelerated
approval of
Millennium's (BSR #4:
Prostate Cancer) and ILEX's Campath
for patients with chronic lymphocytic
leukemia (CLL) who have been
treated with alkylating agents and
have failed fludarabine therapy.
Cam-
path won't be a blockbuster drug for
the companies, but it's a psychologi-
cal boost for Millennium to be able to
get a drug through FDA regulatory
hurdles.
December 13,
Praecis (BSR #45:
ple of days later, the FDA granted
marketing approval for the pediatric
version for Tamiflu, which will be
available by mid-January 2001.
Good
news for both companies: more mar-
ket penetration with the hopes of
more sales and earnings.
On December 21, Gilead Sci-
ences initiated a Phase II trial of NX
211 in patients with recurrent small-
cell lung cancer. This trial is designed
to evaluate the anti-tumor efficacy and
safety of NX 211 in up to 87 patients
at numerous sites in the United States.
NX 211 is a liposomal formulation of
a new topoisomerase I inhibitor being
developed for the potential treatment
of various solid-tumor cancers.
On December 20,
ICOS (BSR
#17: Asthma) and Texas Biotechnol-
ogy Corporation announced the initia-
tion of Phase I testing of TBC3711 to
determine the safety and tolerability
of TBC3711 in healthy volunteers. It
is the second oral endothelin A recep-
tor antagonist to enter clinical devel-
opment. The companies hope their
TBC3711 can begin Phase II testing
in either congestive heart failure or
essential hypertension by the second
half of 2001. In addition, both compa-
nies expect to initiate a Phase IIb/III
clinical trial with Sitaxsentan, also an
endothelin A receptor antagonist, in
the first quarter of 2001as an oral
treatment for pulmonary arterial hy-
pertension.
On December 8, Canada ap-
proved
Immunex's (BSR #5: Rheu-
matoid Arthritis) Enbrel for the treat-
ment of moderately to severely active
in the U.S. Tracleer is used to treat
pulmonary hypertension and acute
and chronic heart failure.
On December 26, the FDA com-
pleted its review of
Genzyme's (BSR
#8: Cardiovascular) biologics license
application for Fabrazyme, an enzyme
replacement therapy for Fabry dis-
ease. As a next step in the marketing
approval process for Fabrazyme, the
FDA has requested clarification of
several points, identified additional
data it needs and emphasized the im-
portance of initiating the planned
Phase IV clinical study. According to
Genzyme, the product development is
on track,
but the market perceives it
as a delay and has reacted negatively
to the news. At the same time, Tran-
skaryotic Therapies has their drug for
Fabry disease and the question is who
will get FDA approval first.
On December 5,
Gilead Sciences
(
BSR #34: Influenza) acquired exclu-
sive worldwide development and mar-
keting rights to a Glaxo Wellcome
investigational compound that has
shown promise in slowing cancerous
tumor growth. The compound,
GW1843U89, is in a Phase I clinical
trial. Gilead will reformulate the com-
pound and immediately initiate pre-
clinical development, with the goal of
submitting an investigational NDA to
the FDA for the product in 2001.
On December 12, Gilead Sci-
ences and Roche received regulatory
approval for Tamiflu from the Japa-
nese Ministry for Health and Welfare,
for the treatment of influenza A and B
virus infection in adults. Then a cou-
BioTech Sage Report, January 2001
