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BioTech Navigator Investment Newsletter - News 8 97 (Page 14)

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BioTech Navigator Investment Newsletter - News 8 97
14
BioTech Navigator, August 1997
will also receive royalties on Abbott's
pharmacogenomics diagnostic sales.
Genset reports second quar-
ter earnings to be a loss of 3.61 french
francs compared to a loss of 3.33
french francs for the same period, a
year earlier.
Gilead (Issue #2-AIDS-
related) reported second quarter to be
9 cents per share compared to a loss
of 43 cents per share for the same pe-
riod of 1996.
On July 25
th
,
Hybridon
(Issue #2-AIDS-related) stopped de-
velopment of its GEM91 antisense
drug due to new data from an open
label Phase II trial of patients with
advanced HIV. GEM91 is a first gen-
eration antisense oligonucleotide
which targets the gag site in the HIV
genome.
Hybridon said the Phase II
trial indicated that chronic therapy for
advanced HIV patients with GEM91,
in combination with other antiretrovi-
rals, would likely require periodic
dose interruptions to allow platelet
levels to increase. In the Phase II
trial, three of the nine subjects tested
experienced decreases in platelet
counts that required dose interruption.
In addition, the genetic drug maker
said a review of the trial data showed
inconsistent responses to the treat-
ment and failed to confirm the de-
crease in cellular viremia observed in
an earlier trial. Hybridon said it be-
lieves that its second generation
oligonucleotides will have a substan-
tially greater therapeutic index than
GEM91.
As a result, Hybridon's stock
price falls, 1 3/4 to 3 dollars, a 36.8%
loss and it has withdrawn its shelf
registration for a 5 million common
share offering.
Hybridon received two
patents for mixed backbone antisense
oligonucleotides. According to Hy-
bridon, it is the first patent claims as
compositions of matter mixed back-
bone "hybrid" oligonucleotides. The
second patent claims as compositions
of matter mixed backbone "inverted
hybrid" oligonucleotides. Hybridon
said in animal testing the two mixed
backbone oligonucleotides demon-
strated pharmaceutical attributes sub-
stantially more favorable than those of
first generation antisense drugs.
In mid July,
Incyte (Issue
#5-Genomics) filed to offer 1 million
common shares. In a filing with the
Securities and Exchange Commission,
Incyte said it will use proceeds from
the offering for capital expenditures,
strategic equity investments in joint
ventures, acquisitions of businesses
and technologies, and other general
purposes. Incyte will have 11.6 mil-
lion shares outstanding after the offer-
ing.
For the second quarter, In-
cyte had 17 cents per share earnings
and for the same period of 1996, earn-
ings were a loss of 16 cents per share.
The increase in its revenues was
driven predominantly by an increase
in Incyte's number of database collab-
oration agreements.
For the year to date earnings,
26 cents per share compared to last
year's earnings loss of 36 cents per
share.
Isis (Issue #2-AIDS-related)
reported second quarter earnings to be
a loss of 36 cents versus a loss of 29
for the same period in 1996. Isis said
attributed its revenue increase in the
latest second quarter to amounts
earned under collaborative research
and development agreements with
Novartis AG (NVTSY) and
Boehringer Ingelheim International
GmbH in support of clinical develop-
ment efforts. And it expects develop-
ment expenses to increase in the fu-
ture as drug candidates continue to
progress through clinical trials.
On July 1
st
,
Liposome (Issue
#4-Breast Cancer) received approval
for Abelcet in Canada. Abelcet is for
the treatment of aspergillosis in pa-
tients who have not responded to, or
are intolerant of conventional ampho-
tericin therapy. Aspergillosis is a fun-
gal infection.
In mid July, Liposome reac-
quired all development, manufactur-
ing and marketing rights to TLC D-
99, liposomal doxorubicin, from its
development partner, Pfizer Inc.
(PFE). Liposome will also assume
control, after a transition period, of all
clinical studies including the ongoing
U.S. and international Phase III clini-
cal studies testing TLC D-99 as a
treatment for metastatic breast cancer.
Pfizer will receive royalties on world-
wide commercial sales of TLC D-99,
except for in Japan. Pfizer will also
provide a credit line of up to $10 mil-
lion to continue the development of
TLC D-99, and to the extent that any
funding is actually used by Liposome,
the outstanding principal and interest
would be repayable beginning upon
receipt of FDA clearance to market
TLC D-99 or in 5 years, whichever is
earlier. Under the agreement, Pfizer
would be entitled to convert any fund-
ing used by Liposome to Liposome
common stock at then-prevailing mar-
ket prices.
Currently, TLC D-99 is be-
ing studied in two Phase III clinical
trials in metastatic breast cancer in
the U.S. and in a third study in Eu-
rope. In the U.S., a single agent study
is designed to compare TLC D-99 to
conventional doxorubicin. The combi-
nation study compares the two drugs
when each is administered with cy-
clophosphamide. The primary end
point of the studies is to demonstrate
that TLC D-99 is significantly safer
with regard to reduced cardiotoxicity
while maintaining equivalent efficacy
to conventional doxorubicin. The Eu-
ropean study compares TLC D-99 to
epirubicin.
For the 2
nd
quarter, Liposome
reported a loss of 23 cents per share
compared to a loss of 17 cents per
share for the same period in 1996.
The earnings include a $3.9 million
for special charges for corporate re-
structuring and other nonrecurring
charges resulting from the failure of a

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