14
According to Immunex (BSR #6:
Rheumatoid Arthritis), Enbrel is sell-
ing at a rate of about $500 million a
year, beating an internal goal of hit-
ting the $500 million mark in the year
2000. The company expects it will
have sales of at least $2 billion a year,
a level that would make it one of the
biotechnology industry's most success-
ful products.
On December 6
th
, Immunex an-
nounced the FDA Advisory Commit-
tee will review data on Novantrone for
the treatment of secondary progressive
multiple sclerosis (MS) in January
2000. Immunex filed a new drug ap-
plication (NDA) for expanded label-
ing for Novantrone on June 4, 1999.
Novantrone is currently marketed to
treat pain in patients with advanced
hormone-refractory prostate cancer in
combination with corticosteroids and
for initial therapy of acute nonlym-
phocytic leukemia.
Approximately 140,000 MS pa-
tients in the US have a form of the
disease classified as secondary pro-
gressive. There are currently no ap-
proved treatments in the US for peo-
ple with secondary progressive MS.
On December 22
nd
, shares of In-
cyte (BSR #5/#28: Genomics) soared
on the news that its scientists, in col-
laboration with researchers at Brit-
ain's Cambridge University had con-
firmed a key gene responsible for a
type of diabetes. The gene was re-
sponsible for type 2 diabetes, severe
insulin resistance, a trait associated
with type 2 diabetes, and early onset
hypertension. The discovery, re-
ported in the December 23th issue of
the journal Nature, will aid the devel-
opment of more effective drugs for
type 2 or adult onset diabetes which
accounts for an estimated 95 percent
of diabetes cases worldwide.
Diabetes, a disease characterized
by abnormally high sugar levels in the
BioTech Sage Report, January 2000
cer products, for which Isis is going to
require money or partners in order to
proceed with development.
On December 9
th
, Isis announced
that is beginning a Phase IIa study of
a topical formulation of ISIS 2302 in
psoriasis patients. In preclinical stud-
ies, the proprietary cream formulation
of ISIS 2302, when administered topi-
cally, reduced ICAM-1 levels in mod-
els of skin inflammation. This formu-
lation of the drug was also very well
tolerated in these studies.
On December 7
th
, Isis announced
that it has begun a Phase IIa study of
an enema formulation of ISIS 2302 in
ulcerative colitis patients. In preclini-
cal studies, ISIS 2302, in an enema
formulation, was well-tolerated, and
potentially therapeutic amounts of the
drug were absorbed by the lining of
the intestine which is inflamed in pa-
tients with ulcerative colitis. This
randomized, placebo-controlled study
will enroll 40 patients at sites in
France, Belgium and the Netherlands.
Ulcerative colitis is an inflammation
of the colon that affects about 800,000
people worldwide.
Millennium (BSR #4: Prostate
Cancer) announced the completion of
its merger with LeukoSite, Inc., on
December 22
nd
, in which Millennium
acquired LeukoSite in a stock-for-
stock exchange.
On December 20
th
, Millennium
announced that one of its partners in
oncology, Eli Lilly has accepted a
validated target for drug candidate
screening in the field of prostate can-
cer. This accomplishment triggers an
undisclosed milestone payment from
Lilly to Millennium.
On December 9
th
, Millennium
announced that it has entered into a
collaborative agreement with Biacore
International AB (BCOR) under
which Millennium will evaluate Bia-
core's latest instrumentation in drug-
discovery applications. Biacore's new
blood, is the fourth leading cause of
death by disease in the US. World-
wide, 130 million cases were reported
in 1997 and 300 million cases are pre-
dicted by the year 2025.
On December 7
th
, Incyte, an-
nounced it has filed a patent infringe-
ment suit against Gene Logic Inc..
The suit alleges infringement of three
patents covering microarray and gene
expression technologies used in the
creation of gene expression databases.
These patents either help identify dis-
ease-associated genes, such as cancer
or enables researchers to obtain a
large enough RNA sample size from
cellular mRNA.
On December 15
th
, Isis (BSR #2/
#26: AIDS-related/Antisense) shares
plummet after the company said it
would not pursue a planned regulatory
filing for its experimental drug ISIS
2302 for Crohn's disease because of
disappointing clinical trial results.
ISIS 2302 is an antisense inhibitor of
Intercellular Adhesion Molecule-1
(ICAM-1), which plays a pivotal role
in inflammation and was their flag-
ship product. This is a big setback.
Isis had been expected to file a new
drug application with the FDA by the
end of the year.
The company said it would make
a final decision regarding develop-
ment of the drug after a full investiga-
tion of the latest trial results, which
showed a complete response in just 12
percent of patients who received the
drug. The negative trial results were
unexpected.
Isis still plans to continue trials of
2302 for treatment of ulcerative colitis
and in a topical form for psoriasis. If
Isis decides to continue with the drug
in the treatment of Crohn's, it would
probably need to conduct further clini-
cal trials, pushing any regulatory fil-
ing well into next year.
The company's drug pipeline also
includes two development-stage can-
