13
BioTech Navigator, March 1998
gen has also been accepted as fileable
and will undergo review. Thyrogen is
a recombinant human thyroid stimu-
lating hormone that is designed to
help physicians manage, treat and
care for thyroid cancer patients.
In early February, Genzyme's
Molecular Oncology unit signed an
agreement to license its cancer assay
methods for screening small-molecule
compounds to Merck & Co. (MRK).
Genzyme's assay methods are used to
screen small-molecule compounds for
their reaction to a cancer-related com-
pound, called MDM2. High levels of
the MDM2 protein have been found
in various cancers, including
leukemia, sarcomas and neural, blad-
der, renal and breast cancers. Under
the non-exclusive pact, Genzyme
Molecular will receive an upfront pay-
ment and could receive $8 million in
milestone payments and royalties on
sales if Merck successfully develops a
therapeutic product using the assay
methods.
Immunex's (BTN Issue #3/5:
Prostate Cancer/Rheumatoid Arthri-
tis) 1997 fourth quarter earnings and
year end results were a loss of 12˘ per
share and a loss of 40˘ per share, re-
spectively compared to a loss of 77˘
and a loss of $1.35. The 1997 fig-
ures includes an $18.1 million charge
related to a legal settlement.
On February 5, Immunex said
laboratory findings suggest Leukine -
or soluble, trimeric CD40 Ligand -
may block HIV entry into human
macrophages. Immunex also pre-
sented positive findings of a safety
trial evaluating the use of Leukine in
patients on stable anti-retroviral ther-
apy. These findings indicated
Leukine didn't increase viral load and
may actually have contributed to a
reduction in viral load. Leukine has
been associated with an increase in
the number of CD4+ T cells in a sig-
nificant number of treated individuals
relative to the control group.
Immunex said it will continue both
uman papillomavirus (HPV) to im-
prove the detection of cervical cancer
and is the only FDA-approved test for
the detection of HPV.
In early February, Digene said
BMI Health Services "incorporated"
human papillomavirus testing in its
women's health screening program to
identify cervical smear abnormalities
using Digene's Hybrid Capture. BMI
Health, a health-care provider in the
U.K., is piloting the program in two
health centers. BMI Health expects
all its locations to offer the program
by the end of 1998 or early 1999.
Also, Digene said a study shows its
new HIV RNA test can detect as few
as 100 copies of the HIV virus per
millileter of blood. The test is more
sensitive than its previous HIV RNA
test, which detected 500 copies of HIV
per milliliter. The company said it
expects the test to be available in se-
lect international markets in the fall,
subject to regulatory approval.
Geltex (BTN Issue #8: Cardiovas-
cular) reported 1997 fourth quarter
earnings and year end earnings to be a
loss of 41˘ per share and a loss of
$1.80 per share in comparison to
1996's earnings to be a loss of 59˘
and a loss of $1.60 per share. Geltex
said total research and development
spending was $11,334,000 versus
$8,968,000 in the quarter and
$31,447,000 versus $21,755,000 in
the full year. Revenue increase was
due to the receipt of reimbursement
amounts from its joint venture with
Genzyme General.
In mid-February, Genzyme (BTN
Issue #8: Cardiovascular) said the
FDA agreed to consider the com-
pany's new drug application for Thy-
rogen under its priority review pro-
cess. Under the priority review pro-
cess, the FDA must make a decision
within six months of the new drug
application (NDA) filing date. The
company submitted the application in
December. Its European marketing
authorization application for Thyro-
cance of Integrilin for treating pa-
tients with unstable angina. The suit
also alleges that the defendants artifi-
cially inflated Cor Therapeutics' stock
price to profit from a common stock
offering. The suit was filed on behalf
of holders from Aug. 25, 1997 to Jan.
28, 1998 and seeks to recover dam-
ages.
On Jan. 28, a FDA panel recom-
mended that Integrilin be approved
for preventing clots in patients under-
going angioplasty, but rejected the
company's attempt to win a recom-
mendation for Integrilin's use in
treating unstable angina.
Corvas (BTN Issue #9: Cardio-
vascular) reported 1997 year end re-
sults to be a loss of 18˘ a share and
fourth quarter earnings to be a loss of
11˘ per share compared to 1996 earn-
ings which were a loss of 52˘ per
share and 10˘ for the same period.
Late February, Corvas received a
$1 million milestone payment from
Pfizer Inc. (PFE) after Pfizer began a
Phase I trial of a Corvas-discovered
product, neutrophil inhibitory factor.
Neutrophil inhibitory factor can po-
tentially block the progress of white
blood cells that damage the brain after
a stroke. Pfizer has exclusive rights
to develop and manufacture the prod-
uct as a therapeutic agent.
Corvas' Chief Financial Officer
and Executive Vice President John E.
Crawford resigned for personal rea-
sons, effective April 3. Crawford
plans to assume part-time status as a
company consultant through June 15,
1998.
Digene's (BTN Issue #2: AIDS-
related) 1997 second quarter results
were a loss of 15˘ a share and the six
months period a loss of 32˘ per share.
In comparison to 1996 for the same
period, losses were 10˘ per share and
32˘ per share.
Digene said on February 19
th
, Blue
Shield of California is now providing
coverage for Digene's Hybrid Capture
HPV DNA test. The test is to detect
