8
T his section is not only to update and in-
form our readers on the significant news of
those stocks that are in our BioPortfolio, but
to provide insight, market conditions that
will influence the biotech sector.
SPOTLIGHT BIOPORTFOLIO
Additions:
Deletions:
Rating Changes:
1. ALXN change from buy to hold.
2. BGEN change from buy to hold.
3. ENZN change from buy to hold.
4. SCIO change from buy to sell.
Key Dates:
BGEN: FDA approval given on Janu-
ary 31, 2003 fir Amevive
DNA: Xolair FDA approval for severe
allergic asthma in the second half of
2003. Raptiva FDA approval for moder-
ate to servere psoriasis in the Q4/2003.
Tarceva and Avastin Phase III clinical
data to be released sometime mid-2003.
ISIS: Survival data for Affinitac to be
released sometime in March 2003.
MLNM: Possible FDA approval in
Q3/2003 for Velcade.
RGEN: Phase III clinical interim data
for Axokine is expected to be released
Q2/ 2003.
SEPR: Esoterra anticipated to be ap-
proved in mid-December.
TRMS: FDA approval could come on
March 16, 2003 for Fusion
#####
BioTech Stock Updates
BioTech Stock Report, March 2003
time.
Phase II clinical studies with An-
tegren show that the drug has a bene-
ficial effect in suppressing new lesion
formation in the brain if administered
chronically. The product provides key
benefits of a rapid onset of action and
a convenient mode of administration.
Antegren provides a complemen-
tary therapy to Avonex that will allow
the expansion of Biogen's market fran-
chise in the MS area. Currently, two-
thirds of MS patients worldwide are
either untreated or not adequately
treated with current options. The addi-
tion of Antegren could provide an ad-
ditional therapy to address this patient
population.
Antegren is also being studied in
Phase III trial for the treatment of
Crohn's disease. The Phase III trial
study is fully enrolled with over 850
patients. The Crohn's disease trial is
designed in two parts, one to identify
patients who will respond to therapy
rapidly as the primary end point, main-
taining disease remission, which will
be a change in the Crohn's disease
activity index, a measurement of
Crohn's activity and severity. The sec-
ond part is to demonstrate disease
control at a once-monthly dose. The
company hopes to file for regulatory
approval by year-end 2003 or early
2004.
During the third quarter of 2002,
Biogen's partner, Celltech, announced
negative results from two Phase III
clinical studies of Humicade, or CDP
571 for Crohn's disease. Biogen is
awaiting the outcome of Celltech's
meeting with the FDA before making a
decision to continue or to terminate
this collaboration. It is more than likely
that the parties will end their collabora-
tion.
Then there is IC747, an oral small
molecule LFA-1 (leukocyte function-
associated antigen-1) antagonist. LFA-
1 antagonists block the action of LFA-
1, which promotes T-cell migration and
activation that can lead to inflamma-
tory diseases. IC747 is being co-
developed with ICOS for the treatment
of psoriasis and other autoimmune
diseases. Results from a Phase II study
of this compound in psoriasis is ex-
pected to be released at the Interna-
tional Psoriasis Society (IPS) meeting
in New York in mid June. Biogen ex-
pects to initiate a Phase IIb study in
psoriasis in the second half of 2003.
Adentri is an alpha-1 adenosine
receptor antagonis t in Phase II trials
for the treatment of acute and chronic
congestive heart failure. The agent
works by blocking the A-1 adenosine
receptor in the kidney, resulting in the
protection of kidney function and the
excretion of sodium and fluid. Adentri
is being developed in collaboration
with CV Therapeutics.
Biogen is one of a few biotechnol-
ogy companies with worldwide sales
and marketing capabilities. It also has a
blockbuster drug, Avonex, that topped
worldwide sales of $1 billion in 2002. In
the near term, earnings growth and
stock performance will largely depend
on the successful launch of Amevive.
In the long run, Biogen, with its efforts
to build a MS franchise around
Avonex that includes Biogen's next
key MS drug, Antegrin, as well as tar-
geting psoriasis and Crohn's disease
for new markets to enter, remains a
strong company. However, we will
change our rating on Biogen from a
buy to a hold, until Biogen provides
updated financial guidance. $$
