14
Corporate Presentation 2020

Corporate Presentation 2020 · • Photodynamic therapy of mild actinic keratoses lesions on the face and scalp (hairless areas). • First registered in 2009 (Europe) and currently

  • Upload
    others

  • View
    0

  • Download
    0

Embed Size (px)

Citation preview

Page 1: Corporate Presentation 2020 · • Photodynamic therapy of mild actinic keratoses lesions on the face and scalp (hairless areas). • First registered in 2009 (Europe) and currently

Corporate Presentation 2020

Page 2: Corporate Presentation 2020 · • Photodynamic therapy of mild actinic keratoses lesions on the face and scalp (hairless areas). • First registered in 2009 (Europe) and currently

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.

2

Disclaimer

Page 3: Corporate Presentation 2020 · • Photodynamic therapy of mild actinic keratoses lesions on the face and scalp (hairless areas). • First registered in 2009 (Europe) and currently

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

3

photonamic GmbH Co. & KG.

Page 4: Corporate Presentation 2020 · • Photodynamic therapy of mild actinic keratoses lesions on the face and scalp (hairless areas). • First registered in 2009 (Europe) and currently

4

photonamic History

* Photonamic is licensor to the local MAH

*

*

*

*

*

Page 5: Corporate Presentation 2020 · • Photodynamic therapy of mild actinic keratoses lesions on the face and scalp (hairless areas). • First registered in 2009 (Europe) and currently

5

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

Page 6: Corporate Presentation 2020 · • Photodynamic therapy of mild actinic keratoses lesions on the face and scalp (hairless areas). • First registered in 2009 (Europe) and currently

6

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

Page 7: Corporate Presentation 2020 · • Photodynamic therapy of mild actinic keratoses lesions on the face and scalp (hairless areas). • First registered in 2009 (Europe) and currently

7

“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)

Page 8: Corporate Presentation 2020 · • Photodynamic therapy of mild actinic keratoses lesions on the face and scalp (hairless areas). • First registered in 2009 (Europe) and currently

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

8

Page 9: Corporate Presentation 2020 · • Photodynamic therapy of mild actinic keratoses lesions on the face and scalp (hairless areas). • First registered in 2009 (Europe) and currently

• 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

9

* Gliolan® SmPC in the EU: https://www.ema.europa.eu/en/documents/product-information/gliolan-epar-product-information_en.pdf

Gliolan®

Page 10: Corporate Presentation 2020 · • Photodynamic therapy of mild actinic keratoses lesions on the face and scalp (hairless areas). • First registered in 2009 (Europe) and currently

• 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

10

Page 11: Corporate Presentation 2020 · • Photodynamic therapy of mild actinic keratoses lesions on the face and scalp (hairless areas). • First registered in 2009 (Europe) and currently

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

11

Page 12: Corporate Presentation 2020 · • Photodynamic therapy of mild actinic keratoses lesions on the face and scalp (hairless areas). • First registered in 2009 (Europe) and currently

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

12

Page 13: Corporate Presentation 2020 · • Photodynamic therapy of mild actinic keratoses lesions on the face and scalp (hairless areas). • First registered in 2009 (Europe) and currently

13

= 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.

Page 14: Corporate Presentation 2020 · • Photodynamic therapy of mild actinic keratoses lesions on the face and scalp (hairless areas). • First registered in 2009 (Europe) and currently

Thank you for your attention