March 14, 201

WEEK OF MARCH 14, 2011
BioCentury
Volume 19 • Number 12 • Page A1 of 17 Chronically obstructed
By Aaron Bouchie
BioCentury This Week
Senior Writer
The FDA panel review of Novartis
AG’s Arcapta Neohaler for COPD will
Cover Story
Regulation
History Lesson — An FDA panel’s recommen-
Chronically Obstructed — 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- ‘Phenomenal’ Bump — Pharmasset added
Marketing
more than a half billion dollars to its market LEAPing Forward — 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- ing Tracleer./A6
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 Future Leaders
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
well./A8
annual Future Leaders in the Biotech Company index/A5
Emerging Company Profile
BioCentury 100TM Indicators
Finding Nimo — Edge believes local delivery
Week ended 3/11/11
BIO Savings
of its sustained-release nimodipine to prevent delayed complications of brain hemorrhage Early bird registration rates still will provide greater efficacy and fewer safety 701.4M shrs
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.
www.biocenturytv.com
BioCentury, THE BERNSTEIN REPORT ON BIOBUSINESS
Edge Therapeutics: Finding nimo
By Erin McCallister
orally or via a feeding tube at 60 mg every Senior Writer
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. believes its
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
Association’s International Stroke Con-
ference in Los Angeles showing that 30 mg American Stroke Association, Dallas,
from SurModics Inc.
Edge Therapeutics Inc., Newark, N.J.
SurModics Inc. (NASDAQ:SRDX), Eden
The search for intelligent life
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