Transcript Story of AntiOp, Inc. (f/k/a Alcomed, Inc.)

Story of AntiOp, Inc.
(f/k/a Alcomed, Inc.)
Daniel Wermeling, Pharm.D.
President and CEO
Professor of Pharmacy
University of Kentucky College of Pharmacy
Starting History
• My background
• Opioid overdose is health crisis
• Opioid antidote expansion in public policy
discussion
• Antidote (naloxone) is approved only as injection
• Naloxone IP expired
• IP for nasal spray is prior part
• Filings with FDA, NIH and State to address public
health need and seek grants and research
approvals
Is Commercialization of Naloxone Nasal Spray
Possible? Can It Pass Tests?
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Company Formation
Intellectual Property
Unmet Medical Need
Business Plan
Market Assessment
Capital Needs
Political Position
Product Design
– Formula
– Device
– Product
• FDA Regulatory Strategy
– CMC
– Pharm/Tox
– Clinical
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Cost of Goods
Commercial Production
Competition
Market Exclusivity
Pricing
Partner/License
Exit
Development Plan
• Work it forwards and backwards
– Meaning starting from scratch and going forward to
launch
– Consider the actual usage in healthcare and how
medical personnel (MD, RN, RPh) and patients will use
• And the steps necessary to support the vision going
backwards
– Consider how it fits into traditional healthcare
delivery (i.e., drug distribution/administration) and
healthcare finance
– For each market segment
Seek Input From the Governing
Federal Agency Before Grant Filing
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FDA in this case
File pre-IND dossier
Explain product and development plans
ASK THEM QUESTIONS – Like structured interview
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Do you agree there is an unmet need for…..?
Do you agree with seeking approval under…?
Do you agree with product design………?
Do you agree with preclinical plan…….?
Do you agree with clinical study design…..?
• FDA must respond in writing
• The GOLDEN LETTER: Endgame is CLARITY
Then Write The Grant
• One risk factor is removed/diminished for
reviewers – credible FDA plan
• The path is the path
• Virtual versus Brick & Mortar Co.
• Can you do good science?
• Are you in regulatory compliance?
• It is unlikely you can do it all – do not be overconfident
• Get good contractors and consultants
AntiOp History 2
• Awarded STTR Fast-track $ 1.45 M
– SOW – to clinical proof
• State matching funds
– 2 awards ($ 150 and $ 500 K)
– Fills in gaps for what feds can not pay for
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Phase 2 b - $ 3 M/ 3 years
FDA User Fee Waiver ($ 2 M) through SBA
FDA regulatory path clear
Seeking final capital and marketing partner
Concluding Remarks
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Comprehensive assessment early
Resolve weaknesses
Seek early government assessment
Regulatory strategy is driver
Focus on critical path elements adding value
Be virtual where possible
Leverage state and other sources of funding
Know exit point – do only what you do best