March 14, 201
WEEK OF MARCH 14, 2011
19 Number 12 Page A1 of 17
By Aaron Bouchie
BioCentury This Week
panel review of Novartis
’s Arcapta Neohaler for COPD will
— An FDA panel’s recommen-
— The FDA
dation could make epilepsy monotherapy the
panel review of Novartis’ Arcapta Neohaler
only setting in which a drug can be approved
using a historical-controlled trial./A10
toward pulmonary drugs in the U.S. and the
Ebb & Flow
remains in the lead in the race to bringa once-daily long-acting adrenergic re-
— Pharmasset added
more than a half billion dollars to its market
— Gilead has successfully
investors speculated will enable the com-
removed the boxed warning for hepatoxicity
B u t i t s i n d a c a t e r o l l o n g - a c t i n g
from Letairis in PAH, but will need to move fast
treatment of HCV./A11
to capture share from Actelion’s market lead-
Still Some Pop
— Seeing upside for
Benlysta. Exelixis taps the excitement. Aerie
Product Discovery & Development
has horsepower. IPOs: Tranzyme. Also: Elan;
Making Sense of CRP
— Isis, the first
SkyePharma, et al. /A12
reactive protein in the clinic, is readying a
Phase II study in multiple myeloma, and is
Online this week/A16
looking to trials in RA and renal diseases as
Only a month to go before the 18th
Stock charts & tables/A17
annual Future Leaders in the Biotech
Emerging Company Profile
BioCentury 100TM Indicators
— Edge believes local delivery
Week ended 3/11/11
of its sustained-release nimodipine to prevent
delayed complications of brain hemorrhage
Early bird registration rates still
will provide greater efficacy and fewer safety
available for the 2011 BIO Interna-
risks than the generic oral formulation./A9
tional Convention and the BIO Busi-
ness Forum. Please see announcement
This Week in SciBX
BioCentury TV This Week
KICk-Starting European Enterprise
— After cutting its teeth with investments
Vaccines for the Poor -- Making the case
in energy and communications, the European Institute for Innovation and
Technology is moving into the biopharmaceutical space with plans for a round
of seed-stage financing. Please see Table of Contents on A5.
BioCentury, THE BERNSTEIN REPORT ON BIOBUSINESS
Edge Therapeutics: Finding nimo
By Erin McCallister
orally or via a feeding tube at 60 mg every
Edge Therapeutics Inc.
4 hours for 21 days. It is not adjusted for
the calcium channel blocker must be given
at suboptimal doses to reduce the risk of
work demonstrates it can deliver effective
decreased blood pressure and heart rate.
Edge Therapeutics Inc.
any “untoward side effects” such as hy-
NimoGel nimodipine will avoid these risks
lished safety profile will likely enable the
noid hemorrhage, patients are susceptible
straight into Phase II studies in 2012.
to cerebral vasospasm, which limits blood
whether or when it will seek a partner for
strokes and additional tissue damage.
NimoGel. “Once we complete the Phase II
study we will look at our options,” Leuthner
traction of smooth vascular muscle in the
H o w e v e r , s y s t e m i c d e l i v e r y o f
muscle in the heart, and thus is associated
microcatheter into the subarachnoid space.
given at doses that limit its efficacy.
trauma: EG-1964, EG-1960 and EG-1967.
bleeding vessels, NimoGel can be injected
die despite treatment with nimodipine.
into the site of injury during this opera-
proved, off-patent drugs. They do not use
process of raising additional funds,” to
back to their previous way of life,” he told
intraventricular catheter for patients who
directly to the site of injury will allow a
cal data at the American Stroke
’s International Stroke Con-
ference in Los Angeles showing that 30 mg
American Stroke Association
from SurModics Inc.
Edge Therapeutics Inc.
, Newark, N.J.
The search for intelligent life
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