Peter and Rick, I noticed you as contributors on the now-dead CBST board here at SI. I tend to follow Peter's style of investing and try and buy a little of everything hoping my homeruns outnumber my stikeouts. I bought a small position in CBST during the new year selloff as it had been on my watchlist for a long time based on numerous favorable comments about its propects and the need for new antibiotics. This week I received the following write-up on CBST from the Biotech Navigator(Nadine Wong).
Cubist Pharmaceuticals is
in late-stage clinical trials with dapto-mycin,
the compound they licensed
from Eli Lilly years ago to treat VREF
and MRSA. Eli Lilly stopped develop-ment
of daptomycin after early clini-cal
trials found it was associated with
toxicity in humans. Cubist believes it
could modify the dosage and admini-stration
of daptomycin to overcome
the toxicity and retain the therapeutic
profile. Unfortunately, toxicity still
follows daptomycin. But that’s not the
only reason we’re not enthusiastic
about daptomycin. Even if it does re-ceive
FDA approval, Synercid and
Zyvox will still be the first antibiotics
used to combat VREF and other anti-biotic-
resistant nosocomial infections.
Cubist is in question, because one
wonders why they’re still pursuing
daptomycin when Eli Lilly dropped it
years ago. Concerns regarding toxic-ity
still surround the drug. But Cub-ist’s
strength is in its research to iden-tify
novel therapeutic compounds util-izing
VITA™ (Validation In vivo of
Targets and Assays for Anti-infectives),
and this proprietary tech-nology
may pay off. It’s premature to
say if it will bring any new com-pounds
to clinical development, but it
is attracting attention from Novartis,
who is collaborating with Cubist.
Cubist is pushing Novartis’ library of
compounds through its high through
has positive feelings toward. Xoma is
in late-stage clinical trials with Ne-uprex,
their systemic formulation of
recombinant bactericidal/
permeability-increasing protein, rBPI-21,
to treat severe meningococcemia.
The bactericidal/permeability-increasing
protein is found in white
blood cells. It acts early in an infec-tion
to kill gram-negative bacteria and
neutralize their toxins, but there is not
enough of it in the body to overcome
the widespread infection caused by
meningococcemia. The recombinant
version that Xoma is developing,
rBPI-21, binds to endotoxin molecules
(lipopolysaccharide, LOS and LPS) in
living bacteria. This disrupts their cell
walls, killing the bacteria or making
them more susceptible to antibiotics.
At the same time, rBPI-21 enhances
the clearance and neutralization of
endotoxina from living and dead bac-teria,
interrupting the inflammatory
cascade at the earliest possible junc-ture.
Is Neuprex going to be a winner
for Xoma? Obviously the most impor-tant
indicator is clinical data. In Sep-tember
last year, a publication in Lan-cet,
a reputable British journal, re-ported
that data from a Phase III clini-cal
trial. Neuprex was studied in 393
pediatric patients with severe menin-gococcemia.
Although not the “slam
dunk” Xoma would have wanted, the
data indicated that pediatric patients
renal replacement therapies and blood
products. The data were statistically
significant, thus providing some en-couragement.
Neuprex and Xoma have drawn
attention from Big Pharma, as Baxter
and Xoma announced an agreement
in January last year, in which Baxter's
Hyland Immuno division acquired the
worldwide rights to the Neuprex prod-uct,
for meningococcemia and all fu-ture
antibacterial and antiendotoxin
indications. This is a serious vote of
confidence. But let’s not get distracted
from the major point of interest, and
that is FDA approval. Given the infor-mation
available, it’s not going to be
straightforward, and this has a lot to
do with the disease indication. Menin-gococcemia
is a very serious disease
that can progress rapidly. Whereas
other clinical outcomes may not de-pend
upon hours and minutes, suc-cessful
clinical outcomes for menin-gococcemia
do. Thus, BSR believes
that Neuprex will eventually receive
FDA approval for severe meningococ-cemia.
However, don’t expect the
drug to be a blockbuster unless Xoma
expands Neuprex’s indications. One
obvious indication is sepsis, and
Xoma is investigating that now. Sep-sis
is a huge market, but is also a dif-ficult
condition to treat, as the basis of
the disease is not well understood.
George gets a XOMA bonus coverage here as well. Do you guys still follow CBST and agree/disagee with her assessment? TIA. |
