11
BioTech Stock Report, January 2004
mune and Wyeth (Medimmune's mar-
keting partner) to sell FluMist than not
at all. We highly doubt FluMist was
sold at a loss. More importantly, this
vaccine is thought to be able to pro-
tect individuals from the Fujian flu
strain, which is causing most of the
infections, as the vaccine contains a
similar strain, which the traditional vac-
cine does not carry. Besides, a current
study extends the argument that Flu-
Mist provides cross-protection supe-
rior to the injectable vaccine. Results
from the second study, a larger head-
to-head cross-protection study,
should be available in May 2004 and if
positive would help future expecta-
tions for FluMist demand into next
season and beyond. MedImmune
should be able to include a cross-
protection claim in the FluMis t label,
which the injectable vaccines do not
have. This claim would provide posi-
tive, critical marketing point for Flu-
Mist versus the injectable vaccine, and
potentially boost FluMist adoption
rates. Bottomline, next year MedIm-
mune will come into the flu season
much better prepared by this year's
experience, with far greater exposure,
better pricing plans, a negotiated in-
advance insurance coverage, and a
pharmacy network to distribute the
vaccine.
We continue to say buy below
$25 with a target price of $35.
On December 9, Millennium/
NASDAQ: MLNM (BSR #76: Multi-
ple Myeloma) announced promising
preliminary Phase I/II results from a
study examining the use of Velcade in
combination with thalidomide for the
treatment of patients with advanced
stage multiple myeloma that have
failed several prior treatments. Addi-
tional multiple myeloma study data
evaluating the use of Velcade in com-
bination with doxorubicin liposome
injection as well as further safety
analyses from the Phase II SUMMIT
and CREST trials with Velcade were
also presented at ASH.
Its just getting better and better
for Millennium as Velcade is going to
prove to be a multimillion dollar drug.
On December 15, Millennium said
that based on an independent
committee recommendation, a Phase III
APEX trial of its cancer drug Velcade
was stopped early after patients taking
the drug did substantially better than
those in the control group. The
findings of a pre-specified interim
analysis found a statistically
significant improvement in time to
disease progression, the primary
endpoint of the trial in patients
receiving Velcade compared to pa-
tients receiving high-dose dexameth-
asone to treat relapsed or refractory
multiple myeloma. This allows patients
currently receiving dexamethasone the
option of immediately, crossover to
Velcade for injection therapy.
Millennium plans to share the re-
sults from this study at a medical con-
ference in the first half of 2004.
On December 16, Repligen/
NASDAQ: RGEN (BSR #78: Fast
Track) reaffirmed the release of top line
results for a Phase III clinical trial of
Secretin for autism sometime during
ththe week of January 5, 2004. The
study will remain blinded through the
d of the year. No new news, but there
has been a lot of selling pressure on
shares of Repligen. As we have men-
tioned, the medical literature has been
mixed on Secretin for treating autism.
However, any signs of improvement
would
be beneficial for the autism patient as
well as for Repligen. If its share price
falls further, the downside risk be-
comes minimal and the potential for a
greater upside has increased for inves-
tors. Thus, we maintain our buy rating.
On December 2, Sepracor/
NASDAQ: SEPR (BSR #17: Asthma)
announced some good news and some
not so good news. First of all, results
from its Phase III clinical trial for Xo-
penex hydrofluoroalkane (HFA) me-
tered-dose inhaler (MDI), its pocket-
sized inhaler used to reduce the symp-
toms of asthma met the main goal of
producing a statistically significant
reduction in symptoms of asthma rela-
tive to a placebo for both adults and
children.
The Xopenex MDI is a more con-
venient version of Sepracor's existing
Xopenex nebulizer. The inhaler is a
hand-held device, compared to the
large, non-portable nebulizers that are
used mainly at home or in hospitals.
If approved, the drug could sub-
stantially expand the company's market
for asthma treatments, as asthma suf-
ferers can easily carry it in a pocket or
purse.
Sepracor plans to file an applica-
tion for marketing approval in the first
quarter of 2004.
Late in the day, Sepracor an-
nounced the not so good news. Sepra-
