1. http://www.motaen.com/wallpapers/source/i
d/29788
1
From Molecule to Business
29/9/2016
a catalyst to develop
ideas into patient solutions

2. • Pharmaceutical development company established in 2004
• Headquartered in Nijmegen, The Netherlands
• Combining CRO activities with internal development programs
• State-of-the-art laboratories and technology capabilities
• Team with proven industry track records
2
Avivia

3. 3
• Track records in generics, innovative small molecules and biotech from new
to mature/established products
• Experience through leading roles in discovery, formulation development, pre-
clinical and clinical development, manufacturing, regulatory affairs, marketing &
sales
• From start-ups to leading pharma companies
The TEAM

4. • In-house lab for analytical and pharmaceutical product development from bench
to commercial scale cGMP-production (Chemistry, Manufacturing and
Controls)
• Project management of preclinical and clinical development
• In-licensing and investment evaluations
• Identification of and negotiation with development/commercial partners
• Regulatory & market access strategy
• Intellectual property strategy
• Marketing and financial planning
4
The CRO
Avivia is a catalyst and an access point to a network of experts
to help evaluate and develop ideas for better patient care
into commercially viable treatment options.

5. • Our approach to innovation focuses on repurposing of tried
and tested products.
• Repurposing can adress a high unmet need for patients with
lower cost, risk and time to market but requires out-of-
the box thinking
5
In-house projects
Dosing Indication Formulation
Specific Patient
Population
Orphan Drugs Prodrugs Rx-to-OTC Switch Drug Combinations
Drug-device
combinations
New route of
administration
Technology Device

6. 6
Pre-clinical
development
Market
Potential
Exclusivity
Clinical Proof of
Concept
Regulatory
Approach
Clinical Need Concept Development &
Execution
Commercialization
Medical &Scientific
Community
Commercial & Co-
development Partners
Regulatory Experts
Intellectual Property
Experts
API manufacturers
Public &
Government
al Funding
Institutional
Investors
Formulation Experts
Chemical & Analytical
Experts
The Approach

7. • Clinical need: CRPC and limited MoA choices of existing drugs
• Innovation: regulatory pathway and positioning
• Exclusivity: marketing and additional intellectual property
• Life cyle management: follow-up development
• Potential cumulative 10y revenue: €142M (EU)
• Partner: generics+ company looking to build portfolio
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FOS project

8. • Clinical need: PPH and stability of golden standard treatment.
• Innovation: formulation and route of administration
• Exclusivity: marketing and intellectual property
• Potential cumulative 10y revenue: €61M (in partner region)
• Partner: ’international diversified distribution company’
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OXY project

9. • Clinical need: Pouchitis and side effects of current treatment.
• Innovation: formulation
• Exclusivity: orphan drug designation
• Life cyle management: additional indications
• Potential cumulative 10y revenue: €30M (EU & US)
• Funding: Horizon 2020
• Partner: international consortium of expert centers
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MRZ project

10. • Its all about people
• Focus on the patients’ need
• Glue the pieces together, but start with the end in mind
• Innovation can be many things, not just a new molecule
• Leverage networks and stay lean
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Conclusion

11. http://udhao.net/mountaineer-girl-wallpaper/
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Hans Platteeuw
CEO, Avivia BV
Email: hansplatteeuw@avivia.nl
Phone: +31 6 286 75 973
Web: www.avivia.nl
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