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October 1, 2012
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CEOCFO Magazine – The Most Powerful Name In Corporate News and Information
Using its Novel Site-Specific and Sustained-Release Microparticle
Technology Platform, Edge Therapeutics, Inc. is Delivering Drugs to
the Brain to Prevent Complication of Subarachnoid Hemorrhage,
Subdural Hematoma and Intracerebral Hemorrhage
Healthcare
helped create and advance Edge works with some of the Biopharmaceutical
hospital business units, launch world’s foremost scientists and (Private)
innovative new products, and critical care physicians from Edge Therapeutics, Inc.
ships. Mr. Leuthner also served centers to develop proprietary 139 South Street, Suite 102.
as an industry advisor to the formulations of known active New Providence, NJ 07974.
800-208-EDGE
ciety of Critical Care Medicine livery to the site of injury in the www.edgetherapeutics.com
cals as CEO and prior to that croparticle formulations release serving as Director of Market drugs locally and consistently Development for start-up ESP at therapeutic concentrations in Pharma, which sold for $500 the brain, with the objective of million in less than 5 years. Mr. maximizing therapeutic activity Leuthner received his Bache- lors of Science and Masters in systemic side effects seen with Business Administration degree current treatments. Currently, Brian A. Leuthner
from The University of North oral- or i.v.-administered thera- President & CEO

Company Profile:
Brian A. Leuthner, President Edge Therapeutics is a clinical- side effects. Edge’s lead prod-
and CEO of Edge Therapeu-
tics, Inc. has more than 22 pharmaceutical company that croparticles) and EG-1964 are uses its novel site-specific and being developed to prevent pital acute care marketplace, sustained-release microparticle various delayed complications technology platform to deliver after brain hemorrhage. EG- rocritical care. He has held drugs to the brain to prevent 1962 is a proprietary micropar- marketing and sales positions complications of subarachnoid ticle formulation of the generic of significant responsibility at hemorrhage, subdural hema- calcium channel blocker ni- GlaxoWellcome, Ortho Biotech, toma and intracerebral hemor- modipine, while EG-1964 deliv- rhage, all of which currently ers a hemostatic agent. Interview conducted by:
terial that these bioabsorbable ity will be dead or have perma- Lynn Fosse, Senior Editor
sutures are made from, and we nent brain damage after 30 deliver our medicine locally to days as a result of the primary CEOCFO: Mr. Leuthner, what the brain so that we address injury or the delayed complica-
is the concept of Edge Thera-
CEOCFO: Why is it that people
Mr. Leuthner: Edge is a pri-
CEOCFO: Is microparticle de-
biopharmaceutical livery the distinguishing factor? Mr. Leuthner: I think part of it
specific and sustained-release Mr. Leuthner: Yes, there are tients who have serious medi-
microparticle technology to de-
velop a portfolio of life-saving ate Edge. First, the site-specific treated by very specialized doc-acute and critical care products and sustained release technol- to prevent complications that ogy platform is a rather prag- matic approach to overcome were not as hot as they are hematoma, the limitation of oral or intrave- nous administrations. Instead people to understand these tracerebral hemorrhage, and of trying to figure out how to conditions. Also, while local de-head trauma. These conditions outsmart the body’s protective livery to the brain might seem are not being ade- The brain is the last frontier of medicine.
Our products have the potential to truly
revolutionize the treatment for several
unmet medical conditions and ultimately
save lives. - Brian A. Leuthner
adequate. The primary goal of we have gone around it. We’ve think things are obvious but
the company is simple; save figured out a way to deliver that is only in retrospect.
lives. That was the vision as far therapeutic concentrations of CEOCFO: What are you doing
as why this company came FDA-approved medicines to the that is different from what is
about. We said we needed to site of injury, without causing available elsewhere?
do something for these patients unwanted side effects in other
and my partner has been study-
parts of the body, and without Mr. Leuthner: Our lead product
ing the causes and potential requiring doctors to perform is a drug called EG-1962 (ni-cures of this field for over another procedure to adminis- twenty years. The problem was ter it. The other thing that dif- not that we did not have good ferentiates what we are is that plications after ruptured brain medicines. The problem was despite the catastrophic com- you could not get therapeutic plications caused by ruptured rysmal subarachnoid hemor-concentrations of the medicine brain aneurysms, subdural he- to the site of injury in the brain matoma, subarachnoid, in- without causing complications tracerebral hemorrhages and is this condition called delayed outside the brain. We have head trauma, there is limited cerebral ischemia (DCI) where taken this novel idea and research being conducted to- turned it into a site specific and day in these areas. While most after neurosurgeons have se-sustained release microparticle of these patients will arrive cured the bleeding aneurysm, technology. It is the same ma- velopment timeline, we are brain hemorrhages and their sciousness, or slip into a coma ready to launch. Because these complications. In fact Dr. Mac-for no detectable reason. This drugs address unmet medical donald is among the most cited is called DCI and is the leading needs and the fact that these researchers in the world in su-cause of death and permanent are life-saving drugs, we are barachnoid hemorrhage. I have brain damage after the hemor- eligible for fast track approval been working in the acute and CEOCFO: Are you working in gether we are very comfortable
nimodipine, concentrations in Mr. Leuthner: Right now, we tionships and past scientific
the brain are sub-optimal and are doing this on our own al-
thus oral nimodipine is only though we would not count out sight from leading academic marginally effective. For years strategic partnerships. Edge’s researchers doctors have tried to figure out long-term vision is to build a world. Many are extremely ex-how to increase brain concen- ever, they have been stymied acute and critical care drugs develop life-saving medicines. and so far found that it is not and continue to develop medi- CEOCFO: Are you aware of
gerous side effects outside the specific and sustained release other research in the same brain. Edge has finally solved delivery platform as well as de- the problem and is taking this velop other life-saving thera- well known, well-understood pies. Why we can do that is be- cause the vast majority of these Mr. Leuthner: We pretty much
cord of safety, and delivering it patients will receive treatment have the field when it comes to locally in the brain over a pe- at less than 500 hospitals complications after brain aneu- riod of 21 days to dramatically throughout the country, so you rysms, subarachnoid hemor-increase its effectiveness. have a very small number of rhage, and subdural hema- customers that you have to toma. In civilian head trauma CEOCFO: Where are you in reach. A sales force of 25 to 50 and traumatic brain injuries in
the development process?
Mr. Leuthner: EG-1962 is cur-
CEOCFO: Is the medical com-
rently being studied in patients munity aware of Edge? tients so far with the goal of Mr. Leuthner: Somewhat, and Health are heavily supporting
gathering additional safety in-
they are becoming more and research in this area. Edge is formation and determining a more aware. My partner, Dr. R. working closely with the De-therapeutic dose. Because of Loch Macdonald, M.D., PhD. partment of Defense and the the drug’s previous approval, has been involved in the re- we will only conduct one Phase search and clinical trials of lead product - EG-1962 in 2 and then we go all the way to acute care and critical care traumatic brain injury. If you go Phase 3. Additionally, the stud- products for over 20 years. Dr. on clinicaltrials.gov, there are ies are short with outcome Macdonald is a leading scien- tist, clinical researcher, and being studied in the areas that we are exploring, even though eurysm patients and in patients grants, while building a clinical treatments are badly needed. tial to address other unmet leaders in the field of acute and CEOCFO: Does Edge Thera-
peutics have the funding to get lation that is growing and these nally, Edge has a portfolio of to where you need to go? subdural hematomas occur on products that have the potential a routine basis, about three to fundamentally change the Mr. Leuthner: We are currently times as many as your rupture way in which a substantial
working to wrap up a financing brain aneurysm patients.
product EG-1962 to Phase 3 CEOCFO: Is the cost of the products
als. Frankly, EG-1964 is an Mr. Leuthner: For ruptured FDA-approved
cal advisors are really excited tients, the average age of these derstood and have a long track about its potential; it is to pre- patients is fifty years old, with record of safety, and delivering vent recurrent bleeding after a many in their forties. And while them locally over a sustained chronic subdural hematoma. 85-90% of people arrive alive period of time. We feel that this Many older people bump their at hospitals, 75% will be dead approach has the potential to heads and about thirty days or permanently brain damaged dramatically increase effective-later, it results in this big clot on within thirty days. Since there is ness in our target conditions. their brain. Some family mem- currently no really effective These are unmet needs. These treatment options, we do not conditions strike people in the CEOCFO: Why should inves-
surgeons drill a hole in the tors pay attention to Edge? CEOCFO: What should people
Mr. Leuthner: There are four remember most about Edge
primary points that make us Therapeutics? tion, about thirty days later this unique. First, since 2009, we
clot will come back. We believe have taken our lead drug from Mr. Leuthner: The brain is the
that EG-1964 will prevent or concept to use in patients. last frontier of medicine. Our
certainly reduce this recurrence Second, we have attracted two products have the potential to
from happening, which is not of the most legendary and suc-
trepreneurs and scientists to ditions and ultimately save the company, namely Dr. Sol lives. In this industry, isn’t sav- Barer who is a board director, ing lives what it’s all about? CEOCFO: What else is on the and Dr. Bob Langer who chairs
backburner now?
Mr. Leuthner: EG-1962 is our $4 million from private investors
lead product. If it works in an-

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