7
Amgen plans to submit Palifermin's
NDA to the FDA as a treatment for
oral mucositis, a common side effect of
cancer treatment.
Enbrel's sBLA for psoriasis has been
filed in July 2003, look for FDA ap-
proval in early 2004.
The Epogen patent infringement case
between AMGN and Aventis/
Transkaryotic could be resolved by
early 2004.
DNA: The FDA gave marketing ap-
proval for Xolair as a treatment for
severe allergic asthma on June 20,
2003. On Oct. 28, 2003, the FDA gave
approval for Raptiva to treat moderate
to severe psoriasis. Tarceva's Phase
III clinical data as a frontline treatment
was released in early October and was
a disappointment. However, the sec-
ond/third line treatment data will be
released sometime 4Q2003/1Q2004.
Avastin's data was released on May
19th and is very encouraging. On June
26th, Avastin received FDA fast track
designation. DNA has completed its
filing of a BLA for colorectal cancer
with the FDA in late September 2003.
An advisory committee will review
Avastin in December of 2003 with the
hopes of FDA approval in March 2004.
DNDN: Dendreon's Provenge to com-
plete Phase III enrollment for prostate
cancer at the end of the year/early
2004. Data could be available in early
2005. Provenge received fast-track des-
ignation from the FDA on Sept. 4,
2003. The company plans to submit a
rolling BLA for the prostate cancer
vaccine.
ESPR: The company hopes to enter a
partnership for one or more of its prod-
ucts in late 2003 or early 2004.
In the first quarter and the second
quarter of 2004, ESPR will announce
top-line data for ETC-588.
GENZ: A BLA for Myozyme, a treat-
ment for Pompe disease, is targeted to
be filed in late 2004 for both the U.S.
and Europe markets.
On Nov. 21, 2003, the FDA advisory
panel recommended marketing ap-
proval of Hylaform, an injectable soft
tissue augmentation .
ICOS: The FDA approved Cialis on
Nov. 21, 2003.
MEDI: The company plans to release
Phase II safety and efficacy data in the
second half of 2004 for Vitaxin in
prostate cancer and psoriasis.
MLNM: On May 14th, FDA approves
Velcade to be marketed to treat re-
lapsed and refractory multiple my e-
loma. An independent committee
based on Velcade's APEX data recom-
mended the trials to end early be-
cause the results were significantly
positive for those multiple myeloma
patients did better than those in the
control group. MLNM plans to pres-
ent data at a medical conference in
the first half of 2004.
RGEN: The company plans to report
top-line Phase III clinical data for Se-
cretin for autism in the week of January
5, 2004.
BioTech Stock Report, January 2004
As the year ends, biotech indus-
try fundamentals remain strong and we
foresee the momentum will continue
into the New Year as new therapies
such as Genentech's Avastin and Mil-
lennium's Velcade begin their promis-
ing journey for 2004.
For Amgen/NASDAQ: AMGN
(BSR #74: Rheumatoid Arthritis), the
Phase III data using Cinacalcet to treat
secondary hyperparathyroidism phos-
phorous (SHP) and calcium levels sug-
gests strong efficacy with good toler-
ability. The U.S. approval of Cinacalcet
for SHP should happen in the late part
of the first quarter of 2004 with launch
in the second quarter of 2004, which is
6 months earlier than expected. The
SEPR: Esoterra's PDUFA date has
been changed from November 30, 2003
to on or before February 29, 2004.
Xopenex's NDA filing at the end of the
first quarter of 2004 for bronchspasm.
The NDA filing of (r,r)-formoterol for
bronchspasm in patients with chronic
obstructive pulmonary disease at the
end of the first half of 2004.
VRTX: On Oct. 21, the FDA gave mar-
keting approval of Lexiva formerly
known as VX-175 (908) for the treat-
ment of AIDS.
In early November, VRTX released
animal studies that showed Pralna-
casan caused liver toxicity in the ani-
mals and halted the clinical trials for
rheumatoid arthritis.
In its third quarter VRTX decided not
to develop VX-148 for psoriasis.
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