Corporate Presentation 2020 · • Photodynamic therapy of mild actinic keratoses lesions on the...
Transcript of Corporate Presentation 2020 · • Photodynamic therapy of mild actinic keratoses lesions on the...
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Corporate Presentation 2020
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The contents of this presentation are proprietary to photonamic GmbH & Co. KG. They are solely
intended for internal information of stakeholders of photonamic GmbH & Co. KG. Any further
dissemination or publication of information herein requires the prior consent of photonamic
GmbH & Co. KG.
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Disclaimer
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Focus in Development and Marketing of
• photosensitizers and/or pro-drugs in suitable galenic formulations and application systems for a variety of indications
Lead compound
• 5-aminolevulinic acid, 5-ALA
Registered address at
• Eggerstedter Weg 12, 25421 Pinneberg
Speciality in
• Research & Development / Regulatory / Science
• Business Development / Marketing
Parent company
• SBI ALApharma Co. Limited. (Member of SBI Holdings Inc.)
Employees
• 23 employees
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photonamic GmbH Co. & KG.
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photonamic History
* Photonamic is licensor to the local MAH
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SBI ALApharma - Global Business Structure
• Corporation: Hong Kong (Headquarter), Germany, The Netherlands, United States, Canada, Japan, United Arab Emirates
• Market: Over 40 countries in collaboration with partners.
Pinneberg, Germany
Canada
USA
Japan
Hong Kong (Global Headquarter)
The Netherlands
UAE
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What is 5-ALA?
5-ALA = 5-Aminolevulinic acid
• produced naturally in the body
• an early intermediate stage in the synthesis of heme
• surplus of 5-ALA HCl leads by enzymatic process to selective accumulation of protoporphyrin IX (PPIX) in diseased cells
• PPIX: actual photosensitizer
PPIX
5-ALA HCl
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“Light”photodynamic
“Dark”metabolic
Cytochrome C
Heme
Animal
FGS Fluorescence guided
surgery
Oxygen measurement
PDD Photodynamic Diagnosis
PDT Photodynamic Therapy
Chlorophyllfeed
ALA
RDTRadiodynamic Therapy
SDTSonodynamic Therapy
Agriculture
Mitochondrial diseases
Cosmetic
Food supplement
Medical dietary
PPIX
PPIX
Fe2+
5-Aminolevulinic Acid – various field of applications
SFC Mg
Energy household (ATP, NADPH, NADH)
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FGS (Fluorescence guided surgery)
PDD (Photodynamic Diagnosis)
Field of Business
LIG
HT
(ph
oto
dyn
amic
)D
AR
K(m
etab
olic
)
LIGHT
Therapeutic Healthcare Non-Human product
PDT (Photodynamic Therapy) Oxygen measurement
•Gliolan® (Glioblastoma)•Alaglio® (Bladder Cancer)
•Alacare® (Actinic Keratosis)•Glioblastoma - under development
• COMET® (oxygen measurement)
• Mitochondodrial Disease -under development• Ischemic Reperfusion -under development
• Functional Foods/Medical Dietaries• Anti-Aging Cosmetics
• Fertilizers• Animal Feeds
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• Gliolan is indicated in adults for visualisation of malignant tissue during surgery for malignant glioma (WHO grade III and IV)*
• Registered in over 40 countries including EU, USA, Korea, Japan, Australia, New Zealand, etc.
Product (1) – Photodynamic Diagnosis of Glioblastoma
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* Gliolan® SmPC in the EU: https://www.ema.europa.eu/en/documents/product-information/gliolan-epar-product-information_en.pdf
Gliolan®
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• Photodynamic therapy of mild actinic keratoses lesions on the face and scalp (hairless areas).
• First registered in 2009 (Europe) and currently marketed in EU, Australia and New Zealand.
Product (2) – Photodynamic Treatment of Actinic Keratosis
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Development pipeline
(as part of strong IP position)
Pharmaceutical
Compound Indications Territory Pre-Clinical Clinical Phase Submitted Status
I II III/Pivotal
5-ALA FGS - Glioblastoma EU, US, JP, KR, AU, NZ ● ● ● ● ● On market
5-ALA PDT - Actinic keratosis EU, AU, NZ, CH ● ● ● ● ● On market
5-ALA FGS - Meningioma US ● ● ● ● Pivotal trial in preparation
PD G 506 FGS - Breast Cancer US, CA ● ● ● ● Phase III in preparation
5-ALA PDT - Glioblastoma EU ● ● ● Phase II in preparation
Medical Device
Product Indications Territory Pre-Clinical Clinical Phase Submitted Status
I II III/Pivotal
COMET® Oxygen measurement EU ● ● ● ● ● On market
Eagle FGS - Breast Cancer US, CA ● ● ● ● Pivotal trial in preparation
*FGS: Fluorescence guided surgeryPDT: Photodynamic Therapy
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New Opportunity for Novel Therapeutic/Medical Dietary as well as
Cosmetics, Animal Feeds and Fertilizers
• In Japan, 5-ALA is registered as food / cosmetic ingredients and widely accepted as food supplement / functional food / cosmetics product / animal feed / fertilizers.
• Together with iron (Fe2+), ALA will lose its capabilities as a prodrug for photodynamic efficacy. Instead, it will have metabolic function such as:• Influencing glucose metabolism• Positive impact on sleep quality• Improving exercise ability of elderly people• Skin moisturization
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= ALAA fascinating molecule with endless capabilities
SBI ALApharma decided to turn this into products for the benefit and convenience of people
to treat diseases, to increase health and quality of life.
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Thank you for your attention