13
Kline and Vertex and licensed by
GlaxoSmithKline. In this random-
ized, open-label trial, 908 will be
dosed in order to assess its safety, tol-
erability and efficacy in a trial design
that includes a lopinavir/ritonavir
(another form of protease inhibitor)
treatment arm.
#####
earnings quarter, Sepracor's shares
took a beating. Is it justified? And
does Prudential's analyst Peter Drake
correct cite the potential cash woes?
BSR will stick with Sepracor because
with its product pipeline, it still has
the potential to grow and reach profit-
ability. Besides, Drake was the same
analyst who downgraded Supergen
because of delays in Rubetican's clini-
cal trials. After reexamining the sci-
entific papers and contacting the
CEO, BSR cannot find any real prob-
lems. In regards to Sepracor's pend-
ing cash problem, the company's
R&D is supported by its partners, and
they have a full pipeline so they are
going to burn cash. At the same time,
back in March Sepracor's CEO
bought a million dollars worth of Se-
pracor shares at $40, so he feels confi-
dent about the company.
On April 16, Sepracor and Scher-
ing-Plough submitted a new drug ap-
plication to the FDA seeking to
broaden the allergy indication for
Clarinex to include perennial allergic
rhinitis.
BSR does not foresee any
problems with Clarinex getting ex-
panded indications, since the FDA
has approved Clarinex for the treat-
ment of seasonal allergies. What we
need is for Schering-Plough to get
approval on its manufacturing facil-
ity, which could be a matter of time.
On April 24,
Vertex (BSR #12:
Hepatitis C) announced that a Phase
III clinical trial in treatment-
experienced patients has begun with
GW433908 ("908"), an HIV protease
inhibitor discovered by the research
collaboration between GlaxoSmith-
$50.4 million from $47.2 million a
year earlier, but came in below mean
forecast of sales of $52.4 million.
Is
this cause for alarm? No, because it
is setting the stage for the future,
spending money today to have money
tomorrow.
For Millennium & ILEX, the
FDA plans to review data and decide
the fate of Campath's biological li-
cense application by May 19.
April 11, Millennium and BZL
Biologics, L.L.C., a privately-held
company, entered into an agreement
to develop and commercialize anti-
body-based therapeutics targeting
Prostate Specific Membrane Antigen
(PSMA). BZL's humanized J591 anti-
body, directed towards the extracellu-
lar domain of PSMA, is the most ad-
vanced anti-PSMA antibody in devel-
opment. In animal models of prostate
cancer, J591 has demonstrated pro-
found efficacy. The antibody was well
tolerated in Phase I clinical studies
and has been used successfully as an
imaging and therapeutic targeting
agent for primary and metastatic tu-
mors in patients with prostate and
other cancers. A radiolabeled version
of J591 is currently in Phase I studies
in patients with advanced prostate and
nonprostate cancers.
It is too early to
gauge the potential, so it's a wait and
see mode for this alliance.
Bad news for
Sepracor (BSR
#17: Asthma) on April 23 as the two
Phase II clinical trials of its experi-
mental heartburn drug, Ticalopride,
were suspended by Johnson & John-
son, due to a small number of adverse
events reported in GERD and diabetic
patients. Even with a strong sales and
BioTech Sage Report, May 2001
