How does the licensing process differ for in-licensing and out-licensing companies?
- 1. Panel Gary C. Cupit, Pharm D, CEO and Director Somnus Therapeutics, Inc Jones W. Bryan, Ph.D. ,Vice President Business Development and Licensing Supernus Pharmaceuticals Daisy Rivera- Muzzio R. Ph., M.S, MBA, Business Development Consultant PHARMA & BIOTECH LICENSING & PARTNERING: Filling the Pipeline & Growing Market Share Through Strategic Deal-Making .
- 2. Introduction Licensing Activity Trends Licensor vs. Licensee Perspectives Value Assessment Proposition Proposed Solutions
- 3. BioPharm Insight-licensing activity report Q32010
- 4. * Pharmaprojects July 2009
- 6. SOURCE: Elsevier ’s Strategic Transactions
- 7. LL L
- 8. Components to assess the value of the opportunity Licensor (Specialty) Licensee (Small or Large) Early stage development Perform only critical testing for advancement of agent (if discovery based) Novel target or highly differentiated is important and magnified if large pharma Late Stage Development Totally de-risk the asset if known entity or small market The larger the company the more premium placed on de-risked asset and differentiation Commercial analysis Detailed product profile and micro-analysis Input from prescribers, providers and payors with competitive agents – CGS estimates Probability of Technical and Regulatory Success Very High! Preclinical – 5% , Phase I – 10%, Phase II – 20%, Phase III – 50%, NDA File – 80% or wait until ready to commercialize IP assessment Freedom to operate and individual product protection in US/EU Multi country position if large pharma or regional as company size gets smaller (PLCM strategy) Regulatory Strategy Aggressive path with targeted line to approval Clear path with competitive positioning and data Roles/responsibilities at commercialization stage Minimal to full rights to co-promote Pay royalties and milestones to licensor or becomes M&A opportunity
- 9. Components to assess the value of the opportunity Licensor (Mid to Large BioPharma) Licensee (Small) Early stage development Perform broad based testing across multiple targets and define MOA Key development signals for efficacy Late Stage Development First in class or differentiation within class (Efficacy, safety or administration route/schedule) Target indication with single dosage form Commercial analysis Multiple points of original research at key time points of development/ Packaging/ Dosage design, Reimbursement Status Minimal original research Probability of Technical and Regulatory Success Preclinical – 5% , Phase I – 10%, Phase II – 20%, Phase III – 50%, NDA File – 80% Bullish outlook IP/Trademark assessment Coverage of product, field, dosage forms, future indications and broad geography Freedom to operate and individual product protection in US/EU Regulatory Strategy Broad efficacy/safety studies, biomarkers subpopulations, genomic footprint, REMS Aggressive path with targeted line to approval Roles/responsibilities at commercialization stage Pay royalties and milestones to licensee or M&A opportunity Maintain either specialist calls or future co-promote
- 11. … fibs uttered by prospective pharma partners 1 10. “ We never participate in a bidding war ” 9. “ We have all the authority we need to do the deal on these terms ” 8. “ We believe in ‘ equal ’ say in decision making ” 7. “ Our ‘ culture ’ is open and flexible, just like yours ” 6. “ We are in it for the long haul ” – Also known as: “ We would never use the threat of termination to improve our deal ” 5. “ We can close a deal in 30 days ” 4. “ We cannot possibly close a deal in 30 days ” 3. “ This is our best and final offer ” 2. “ Our primary motive is to help suffering patients ” 1. “ We will treat your molecule like it was discovered by our own scientists ” 1 Proceedings of the 22 nd JP Morgan Healthcare Conference, L. Schleifer, CEO, Regeneron
- 12. … fibs uttered by prospective biotech licensors 1 10. “ We have so many offers I can ’ t keep track of them ” 9. “ While I support the deal, my Board will never approve those terms ” 8. “ We have a fabulous patent position with complete freedom to operate ” 7. “ If you don ’ t sign the deal today, the deal is off ” 6. “ You ’ ll make a fortune on the equity ” 5. “ We expect to launch the product in 18 months ” 4. “ This is our crown jewel ” 3. “ Our scientists think your ‘ culture ’ is just like ours ” 2. “ Our sales force will be as good as yours ” 1. “ We ’ ve done extensive market research that shows the product will be a multi-billion dollar blockbuster ” 1 Proceedings of the 22 nd JP Morgan Healthcare Conference, L. Schleifer, CEO, Regeneron
Editor's Notes
- #6: Examples in Biotech's