Farmasøytisk Fagdag 8. Mai 2006

PhotoCure ASALeadership in Photodynamic Therapy

Contents

• PhotoCure ASA - historical background

• Hexvix – “a breakthrough in bladder cancer diagnosis”

• Metvix – “treatment of skin cancer with no scars”

• R&D

• Acne – need for new treatments

• PCI Biotech – photochemical internalisation

• Pipeline

• Pharmacists in PhotoCure ASA

• Sum up

PhotoCure ASA

*Photodynamic Therapy

PhotoCure ASA is a pharmaceutical company listed on the Oslo Stock Exchange (OSE).

The company develops and sells pharmaceuticals and medical devices based on patented photodynamic technologies, targeting selected diseases in dermatology and oncology.

Historical milestones

1994• First patent application

1996• First equity financing

1997• Recruited first full time employees• Start of formal clinical studies for Metvix

2000• First marketing application filed for

Metvix• Listed on Oslo Stock Exchange• Start of Hexvix clinical studies

2001• First marketing authorisation obtained for

Metvix• Signed global licencing agreement for

Metvix with Galderma

2002• First marketing application filed for Hexvix

2003• Galderma’s first Metvix launch

2004• First marketing authorisation obtained for

Hexvix

2005• Hexvix approved in all EU/EEA countries• Hexvix launched in the Nordic region• Marketing application (NDA) filed for

Hexvix in the US

2006• Hexvix licencing agreement with GE

Healthcare• Rights issue of MNOK 191 in net

proceeds

Hexvix - a breakthrough in bladder cancer diagnosis

• Bladder cancer is the 4th most prevalent cancer

• Hevix is approved for bladder cancer diagnosis in Europe

• Sold by GE Healthcare, PhotoCure’s licencing partner, and in the Nordic countries by PhotoCure

Hexvix - procedure in the operating room

One Hexvix kit per patient

Instillation of Hexvix in the bladder, followed by cystocopy after one hour

Mapping of the bladder in white and blue light, biopsies and tumor resection.

Preparation of the Hexvix solution

Bladder picture: Courtecy of Dr. Zaak, Munich

Hexvix - key medical benefits

• Hexvix detects 23 % more patients with CIS than standard white light cystoscopy

• Hexvix improves patient management in 22 % of patients

Source: Jocham D. et al, J Urol 2005; 174:862-866Scmidbauer, J. et al, J Urol 2004; 171:135-138

Picture: Courtecy of Dr. Zaak, Munich

Skin cancer - a growing problem

1. American Academy of Dermatology (AAD)2. Kreftregisteret 2001

Strong increase of non melanoma skin cancer in Norway (2)

• Skin cancer is the fastest growing category of cancer in women in their 20s and 30s.(1)

• As the population ages, this could lead to a dramatic increase in non-melanoma skin cancers

Metvix - mechanism of action

Fluorescence shows that the application of Metvix leads to selective porphyrin accumulation in diseased tissue

Metvix - treatment of skin cancer without scarring

• Approved for AK and BCC in all EU/EEA countries (except France), Australia, New Zealand, Brazil and South Africa.

• Approved for AK in the US

• Approved for Bowen’s disease in 22 EU/EEA countries

• Sold by Galderma, PhotoCure’s licencing partner, and in the Nordic countries by PhotoCure

Lesion preparation

The Metvix procedure - easy and effective

MetvixMetvix applicationapplication Aktilite illuminationAktilite illumination

A strong pipeline within PDT in clinical phase

Clinical Products and Pipeline Pre-clinical Explorative Phase I/II Phase III First Filing Metvix

AK / Aktilite (US)

Immuno-compromised patients*

*Skin dysplasia (BCC, SCC in situ, AK and warts) in immuno-compromised patients.

Hexvix

Bladder cancer – photodiagnosis (US)

Bladder cancer photodiagnosis US follow up

Bladder cancer – photodynamic therapy

MAL (methylaminolevulinate)

Acne Explorative Programmes

Cervical cancer – photodynamic therapy

Colon cancer – photodiagnosis

Photochemical Internalisation (PCI Biotech AS)

Cancer (combination)

Gene therapy / Protein therapeutics

= completed

= ongoing

Isotretinoin(eg.Roaccutan)

Oral Antibiotics

• Highly effective• Long term treatment• Severe side effects• Risk management

program US/EU

• Moderate effect• Long term treatment• Resistance issues

Therapeutic modalitiesCompetitor Segment

Oral Vitamin-A

Oral Antibiotics

Acne patient before treatment

Acne - need for new treatments

Acne - further development

• Proof of concept study with 30 patients with moderate to severe acne

- Metvix PDT gave a significantly greater reduction in the number of inflammatory acne lesions 12 weeks after treatment.

• Phase I/II study ongoing in Canada

• Milestones

• Start of phase II program in 2006

• Start phase III in 2008

PCI Biotech AS - photochemical internalisation

S + light S*

M

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S

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S MM

M

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SS M

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MMM

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Light

photochemical reactions

- PCI Biotech is a subsidiary of PhotoCure.

- PCI is a light-directed drug delivery technology

- developed to introduce therapeutic molecules in a biologically active form specifically into diseased cells.

PCI Biotech AS

• Development of a new PCI photosensitiser is progressing

• Clinical proof-of-concept studies to be initiated

• Collaboration with scientists at the NRH and leading academic groups worldwide

• Main target disease is cancer - potentially cardiovascular, eye, skin and autoimmune diseases.

Professional staff of 35 with world-class R&D expertise

Grete Hogstad – Vice President M & S

Member of management team

– Influence on PhotoCure’s way forward

- future projects, organisation, resource allocation

Responsible for marketing and sales in PhotoCure, Metvix and Hexvix in the Nordic region

– Building organisation and management systems incl. follow-up/coaching

– Establishing product and customer strategies, activities and communication

– Identifying and building key opinion leader- and customer networks

Cooperation with international licence partners (Galderma, GE HealthCare)

– Transfer of knowledge and experience

– Plan and co-ordinate activities and future strategies

No better place for a curious pharmacist with experience from R&D and sales and marketing

-and who needs challenges, -enjoy entrepreneurial work and long working hours

Gry Stensrud – Pharmaceutical Director

Ansvar for forskning, utvikling, og produksjon av Drug Products

Forskning og utvikling

– Ansvarlig for å fremskaffe formuleringer for nye produktkonsepter og indikasjoner

– Ansvarlig for utviklingsstudier (formulering, emballasje, prosess)

– Samarbeid med forskningsmiljøer

– Ansvarlig for farmasøytisk del (Modul 1, 2 og 3) av regulatoriske søknader (CTX, IND, MAA, NDA)

Produksjon

– Ansvarlig for produksjon (ekskl. logistikk) av Hexvix og Metvix- Kvalitet og prosedyrer i samsvar med markeds godkjennelse

- Hovedansvarlig for leverandør/CRO kontakt

- GMP, oppfølging og gjennomføring av corrective actions av avvik, out-of-spec, recalls, complaints, endringer, annual stability, audits, avtaler etc.

- Implementering av endringer i prosedyrer, forbedringer og oppskalering av produksjonen

– Qualified Person (QP) Hexvix (under opplæring)- Legalt ansvar for frigivelse av Metvix og Hexvix for Europeisk marked

Bjørn Klem – Clinical Trial Director/Project Manager

Kliniske programmer for nye substanser eller nye indikasjon

Kliniske undersøkelser innen

– Farmakokinetikk, Farmakologi, Effekt, Bivirkninger and QoL

Gjennomføre selv / outsource studier

– protokoll (Design / metodologi etc.)

– pasientskjemaer

– søknader og monitere

– data håndtering og statistikk

– rapportere og publisere

Registrering klinisk dokumentasjon (strategi, møter f.eks EMEA / FDA)

Prosjektarbeide; Kjemi / farmasi / patent / preklinikk

Relasjonsbygging - sykehus, apotek, CRO, laboratorie, partner m.fl.

Markedsanalyser; Presentasjoner møter / kongresser; Budsjett

Sylvia Vetrhus – Clinical Trial Manager (CTM)Marianne Sletsjøe - CTM and Safety Officer Clinical studies

Regulatory – clinical documentation

Quality Assurance and SOPs

Safety Officer and QP Pharmacovigilance – Metvix and Hexvix

– Premarketing

- Reporting of expedited SAE (SUSARs) clinical studies

- Design safety follow-up in clinical trial and clinical programmes

– Postmarketing safety

- Collection and reporting of (spontaneous) ADR – Nordic countries

- PSURs

- Cooperation with licensees (Galderma and GEHC)

PhotoCure ASA

Farmasøyter med varierte arbeidsoppgaver

”Strong pipeline” – nye spennende prosjekter innen onkologi og dermatologi

Relativt lite forskningsbasert firma

Jobber på tvers av ”avdelinger” - sitter i åpent landskap

”Outsourcing” – utstrakt internasjonalt samarbeid med forskningsinstitusjoner/ partnere / konsulenter

www.photocure.no