12
Europe in the first half of 2002.
ICOS' (BSR # 17: Asthma) first-
quarter earnings were wider, due in
part to increased research spending on
products in late-stage development,
including its impotence drug Cialis
and Pafase for sepsis.
In late April, ICOS announced it
has begun enrolling patients in a
Phase III trial of Pafase, an experi-
mental treatment for sepsis
-
a life-
threatening inflammation resulting
from blood-borne infections
-
for
which there are no approved treat-
ments. Lilly is also developing a sep-
sis drug, Zovant, which reduced mor-
tality rates in patients studied by al-
most 20%. If approved, some analysts
believe Zovant has the potential to
generate annual sales of over $2 bil-
lion. Sepsis is a tough indication to
find a treatment for because it spreads
very quickly via the blood stream.
April 6, Eli Lilly presented at the
European Association of Urology
meeting the first Phase III study for
Cialis used to treat erectile dysfunc-
tion (ED. The drug showed strong
positive results among one of the most
difficult-to-treat populations of men
with ED. The findings demonstrated
that 64% of men with diabetes-related
ED who took Cialis reported im-
proved erections.
Impressive news for
ICOS, and the next report of Phase III
data is due at the American Urology
Meeting on June 2 through 7. Re-
searchers reported no evidence of the
color-vision disturbances that have
been associated with Viagra. The ab-
sence of side effects is especially im-
portant to investors, since ICOS and
Lilly will have a much easier job tak-
ing market share away from Viagra if
Cialis shows a cleaner safety profile.
Cialis is on track for NDA filing.
IDEC (BSR #19: Lymphoma)
delivered good news and not-so-good
news. The goods news is that IDEC
reported solid Q1 earnings. The not-
so-good news is that the FDA has re-
quested additional data, that is, imag-
ing on Zevalin. As a result, the com-
pany expects to receive a complete
review letter from the FDA on or
around May 3 for Zevalin, which
probably will delay FDA approval.
In
regards to the imaging request, it is
more than likely that the FDA is
checking the efficacy of Zevalin to see
if the therapeutic is targeting the can-
cer cells.
April 10,
Inhale Therapeutic
Systems (BSR #41: Drug Delivery)
and Aventis Behring announced suc-
cessful completion of their Phase IB
clinical trial of a novel, inhaleable
form of Alpha1 Proteinase Inhibitor,
currently under investigation for an
inherited form of emphysema caused
by alpha one antitrypsin deficiency.
All doses were well tolerated, patients
were tested for antibodies to the drug,
and no antibodies were detected to
this natural human protein. Further-
more, patients indicated in a post-
study survey that the Inhale delivery
system is easy to use. The inhaleable
drug has been granted orphan drug
designation by the FDA.
On April 2, Eli Lilly and Alker-
mes announced they have signed an
agreement to develop inhaled formu-
lations of insulin, including short-
acting and long-acting insulin, and
other potential products for the treat-
ment of diabetes based on the Alker-
mes AIR pulmonary drug delivery
system.
It looks like increased compe-
tition for Pfizer and Inhale Therapeu-
tics, but Pfizer and Inhale may get
FDA approval first.
MedImmune (BSR #31: Trans-
plantation) reported earnings per
share of 36˘, more than doubling last
year's same-quarter earnings of 13˘
due to Synagis, and meeting the con-
sensus estimate. The company expects
to post a 4˘ to 6˘ loss in Q2 and a
profit of 80˘ to 85˘ for the year.
BSR
anticipates continued growth and
market penetration on Synagis.
April 19, MedImmune and
Genaera entered into a research col-
laboration and licensing agreement to
develop and commercialize antibodies
or recombinant molecules against IL-
9 to prevent symptoms of asthma and
other respiratory diseases.
April 2, MedImmune
began dos-
ing patients in a Phase II clinical trial
of MEDI-507 in psoriasis patients in
North America. Patients are being
recruited for a Phase II study in
Europe, and two additional Phase II
trials are planned to begin later this
year. The company expects to con-
clude its Phase II program with
MEDI-507 around the end of this
year, and the data will decide if
MEDI-201 will go into Phase III.
Millennium (BSR #4: Prostate
Cancer) posted a Q1 loss of 16˘ per
share, which is 3˘ more than expected
and wider than a year-ago loss of 12˘
per share. Quarterly sales rose to
BioTech Sage Report, May 2001
