MARINOMED SOLV4U FORMULATION DEVELOPMENT - SEPTEMBER 2021
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Marinomed Solv4U Formulation Development - September 2021
Disclaimer
This presentation (the “Presentation”) was prepared by Marinomed Biotech AG.
The information contained in this Presentation has not been independently verified and no representation or warranty expressed or implied is made as to, and no
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Marinomed snapshot
A lean biopharmaceutical expert in OTC and Rx therapies
Founded in 2006… …Marinomed established two platforms
Expand on revenue Continued innovation and
generating products IP generation
▪ Clinical effectiveness against ▪ Successful Phase III for
SARS-Cov-2 virus Budesolv (allergic rhinitis)
demonstrated validates platform
▪ First causal therapy for colds ▪ Targeting multi-billion Dollar
and flu-like illnesses markets (allergic rhinitis, dry
▪ Retail sales in >40 countries eye)
Phase III + 55%
€ 42.4m Budesolv with strong
Revenues up from
Financing through IPO, results – technology
platform validated € 5.2m to € 8.1m
EIB and ERP/AWS
Phase II
Tacrosolv clinical trial in
ocular inflammation
4Marinosolv® Technology
6Marinosolv®, the basis for better therapies
Technology platform to improve drug delivery and bioavailability
Enables novel stable formulations
Based on plant derived saponin micelles, proven as clinically safe
Suitable for highly hydrophobic small molecules and peptides
Most advanced asset: Budesolv (Budesonide formulation), preparing application
Supported with a strong patent family (novel use), protection until at least 2036
The technology is not limited to a specific compound and has the potential to facilitate delivery of
potentially any API with solubility issues.
7Marinosolv® enhances bioavailability
Improved solubility as exemplified on the lead product Budesolv
Suspended particles Stable micelles
Rhinocort Aqua (Johnson & Johnson) Marinosolv® enabled
Budesonide nasal spray Budesonide nasal spray
Suspension Solution
64µg per dose/spray 10µg per dose/spray
Properties USPs
Proven Solubility increase versus water shown for variety Increased Faster onset of action
solubility of compounds bioavailability Higher local, lower systemic availability
Well-established and well tolerated by sensitive Lower possible side effects
Excipients tissues like nasal mucosa and eyes
Dose reduction Lower production costs
Misdosing avoided because the need to shake the Preservative free formulation
No misdosing product is eliminated
Aseptic filtering Lower production costs
Marinosolv® – a technology platform with the potential to facilitate delivery of virtually any compound with
solubility issues
9Marinosolv® Formulation Technology Partnerships
14- Solution to your Solubility Issues
Improvement of bioavailability of hardly soluble compounds
Formulation Development – Technology Partnerships
All formulations are
▪ Custom-made
▪ Designed in close cooperation with our clients
▪ Considering the physicochemical uniqueness of each compound
▪ Considering requirements for later development stages and
manufacturing
Target compounds
▪ Potentially any hardly soluble compound (small molecules/peptides)
▪ Use of the technology is not limited to APIs for specific indications
▪ Particularly suited for locally applied, locally acting drugs
▪ Potential to improve bioavailability of orally applied drugs used for
systemic diseases, such as in oncology
▪ Re-Formulation of off-patent APIs: life cycle management
15- Formulation development
From feasibility study to scalable manufacturing process
Project outline
Step 1: Feasibility study
▪ Establishment of analytical method
▪ Design, prepare and evaluate a defined number of modifications of
Marinosolv® formulation with target compound.
▪ 6-day stability data
▪ Report
Step 2: Formulation development
▪ Optimize formulation and evaluate stability
▪ Provide non-GMP study medication
Step 3: Development of manufacturing process
Step 4: Tech Transfer to client/CMO
The license model for the Marinosolv® technology aims to include milestone
payments and royalty fees on the marketed product and is discussed individually
with each client.
16www.marinomed.com
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