16
Prostate Cancer), submitted an NDA
to the FDA for Abarelix Depot for the
treatment of prostate cancer. Abarelix
is a drug that avoids stimulating the
secretion of testosterone, a male hor-
mone that causes the growth of most
prostate cancers. Praecis is developing
Abarelix Depot for commercialization
with Amgen.
Data so far looks good
and BSR anticipates that Abarelix
will get approval.
On December 19, Praecis intends
to initiate in the first quarter of 2001 a
Phase II study of Latranal for the
treatment of localized muscle, tendon
or neuropathic pain. In addition, the
company filed an investigational drug
application for Apan to initiate a
Phase I clinical trial during the first
quarter of 2001 for Alzheimer's dis-
ease.
On December 4,
Protein Design
Labs (BSR #18: Leukemia) presented
data on the clinical status of its
SMART 1D10 Antibody at the
American Society of Hematology.
SMART 1D10 is currently in a Phase
I trial for the treatment of non-
Hodgkin's B cell lymphoma. In addi-
tion, results are encouraging for Phase
II clinical trials of SMART 1D10 in
combination with granulocyte-colony
stimulating factor (G-CSF).
On December 13,
Sepracor (BSR
#17: Asthma) reported that Schering-
Plough has submitted separate NDAs
to the FDA for two new formulations
of its nonsedating antihistamine
desloratadine. The first NDA seeks
clearance to market desloratadine
syrup for the treatment of seasonal
tested during a Phase I/II clinical
study designed to establish safety and
efficacy in the treatment of sickle-cell
anemia.
Currently, Supergen's share
price is continuing to reflect percep-
tion issues ever since Prudential
downgraded the company. So far, the
company appears to be solid and
healthy in its scientific research, but
Supergen will need to fill a couple of
management positions and regain in-
vestors' confidence from negative
comments. At this point, it's best to
watch for any signs of trouble.
On December 7,
Vical (BSR #22:
DNA Vaccines) presented data on its
clinical trials for Allovectin-7 and
Leuvectin, two cancer treatments
showing excellent safety profile and
encouraging efficacy results at a gene
therapy conference for cancer. All-
ovectin-7 is currently in Phase III and
Phase II testing in patients with ad-
vanced metastatic melanoma, and in
Phase II testing in patients with head
and neck cancer. Leuvectin is cur-
rently in Phase II testing in patients
with advanced metastatic kidney can-
cer and in patients with aggressive
prostate cancer.
NOTE: BioPortfolio is not a model portfolio. It
is a list of technologies in the BioTech Sage Re-
port Paradigm and of companies that lead in their
application. Companies on this list are selected
only for their technology leadership, without con-
sideration of their current share price or the appro-
priate timing of an investment decision. The pres-
ence of a company on the list is not a recommen-
dation to buy shares at the current price. Refer-
ence Price is the company's closing price on the
Reference Date, the day the company was added
to the table, typically the last trading day of the
month prior to publication.
*****
allergic rhinitis (SAR) and chronic
idiopathic urticaria (CIU), or hives of
unknown cause, in patients as young
as two years of age. The second NDA
seeks approval to market
desloratadine in a fixed combination
with the decongestant pseudoephed-
rine sulfate as a twice-daily treatment
of SAR in adults and children 12
years of age and older.
BSR interprets
this as a sign that Schering-Plough is
still upbeat about Sepracor and the
new formulation of Claritin.
In early December,
SuperGen
(
BSR #20: Generics) presented a
clinical study at the American Society
of Hematology of its cancer drug,
Nipent, as a salvage therapy
(treatment as a last resort) for graft
versus host disease (GVHD). The
study showed the response rate for the
12 patients to be 75 percent for Nipent
in actively treating GVHD. The com-
pany is planning to initiate a Phase III
clinical trial in GVHD early next
year. At the same meeting, Supergen
presented the results of another clini-
cal study of its cancer drug, Nipent.
The study, conducted at Tufts Univer-
sity-New England Medical Center,
evaluated the safety and efficacy of
Nipent on 13 allogeneic (from a donor
rather than one's self) bone-marrow
transplant patients who received the
drug as part of a "preparative regi-
men" before transplantation. The
study reported that Nipent was "well
tolerated" and showed high rates of
engraftment. Also, SuperGen pre-
sented data on its anticancer com-
pound decitabine that generated a 100
percent response rate in patients
BioTech Sage Report, January 2001
