Monday, June 8, 2009
Embassy Suites, Chesterbrook, Pennsylvania (directions)
A biopharmaceutical drug development company
Edge Therapeutics is a biopharmaceutical drug development company formed in 2008, and incorporated in Delaware in February 2009. Edge’s strategy is to develop proprietary products that solve unmet medical needs in stroke and traumatic brain injury (TBI) by improving current formulations or routes of delivery of existing or emerging drugs. By improving existing formulations rather than developing new compounds, Edge reduces the development risk, development costs and time to market for our products.
Our first product, NimoGel™ (EG-1961), meets these criteria. NimoGel consists of nimodipine, a drug approved by the Food and Drug Administration (FDA) with a long established safety record, and Edge’s own proprietary drug delivery system, a biodegradable sustained release formulation. When NimoGel is placed next to brain arteries after ruptured brain aneurysms or traumatic brain injury (TBI), Edge believes that NimoGel will prevent death and further disability. Preliminary development of NimoGel is underway and following preclinical trials, NimoGel will proceed directly to Phase 2 human trials. NimoGel qualifies for Fast Track FDA approval and priority review because it targets a serious unmet medical need. NimoGel also treats a rare disease so that if approved by the FDA, it would be granted orphan drug status, which would give NimoGel marketing exclusivity for 7 years.
3 Major Issues
- Regulatory: Should we focus on Japan first rather than the US and the EU in view of:
A) Incidence of ruptured aneurysms in Japan is 2X
higher than in the US and EU.
B) Japan may not require pre-clinical toxicity study before Phase II,
...even if we have no Japanese Regulatory Expertise?
- Funding: Where are we missing focus regarding the initial $1M funding? We are talking to private investors, seeking state grants, NJ
Commission on Science and Technology, NJ Commission on Brain
Injury, and SBIR and DoD funding.
- Costs & Pricing:
A) In our initial clinical trials of patients with a ruptured brain aneurysm undergoing surgical clipping, we assume total all-in study costs are $25,000 / patient. Is that too low, too high or just right?
B) Our current forecast assumes that we can garner reimbursement at $37,000 per
treatment for NimoGel. Current therapy is $15 - $20K and when balloon
angioplasty is needed to break the vasospasm, it costs another $20 - $30K. If we are "significantly" better than the comparator, are we charging too low a price?
6:30 - Cocktails & Dinner (Cash bar and special 2-entree buffet menu)
8:00 - Brian Leuthner, President and CEO of Edge Therapeutics will deliver the Company's "Elevator" Pitch to the Group
8:15 - A Panel will address 3 Major Issues for the Company
9:00 - Open discussion: members and guests
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President & CEO
Edge Therapeutics, Inc.
NJIT- Enterprise Development Center Technology Incubator
211 Warren Street
Newark, NJ 07103
TEL: (800) 208-EDGE
CELL: (908) 531-4566
Becker Michael (panelist )
Clementi Bill (panelist)
Harris Dianne (panelist)
Leuthner Brian (presenter)
Macdonald Loch Edge Ther.