Farmasøytisk Fagdag 8 Mai 2006 Photo Cure ASA

Farmasøytisk Fagdag 8. Mai 2006 Photo. Cure ASA Leadership in Photodynamic Therapy

Contents • Photo. Cure 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 Photo. Cure ASA • Sum up

Photo. Cure 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. *Photodynamic Therapy

Historical milestones 1994 • First patent application 2002 • First marketing application filed for Hexvix 1996 • First equity financing 2003 • Galderma’s first Metvix launch 1997 • Recruited first full time employees • Start of formal clinical studies for Metvix 2004 • First marketing authorisation obtained for Hexvix 2000 • First marketing application filed for Metvix • Listed on Oslo Stock Exchange • Start of Hexvix clinical studies 2005 • Hexvix approved in all EU/EEA countries • Hexvix launched in the Nordic region • Marketing application (NDA) filed for Hexvix in the US 2001 • First marketing authorisation obtained for Metvix • Signed global licencing agreement for Metvix with Galderma 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 4 th most prevalent cancer • Hevix is approved for bladder cancer diagnosis in Europe • Sold by GE Healthcare, Photo. Cure’s licencing partner, and in the Nordic countries by Photo. Cure

Hexvix - procedure in the operating room One Hexvix kit per patient Preparation of the Hexvix solution Bladder picture: Courtecy of Dr. Zaak, Munich 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.

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 -866 Scmidbauer, J. et al, J Urol 2004; 171: 135 -138 Picture: Courtecy of Dr. Zaak, Munich

Skin cancer - a growing problem • Skin cancer is the fastest growing category of cancer in women in their 20 s and 30 s. (1) • As the population ages, this could lead to a dramatic increase in non-melanoma skin cancers Strong increase of non melanoma skin cancer in Norway (2) 1. American Academy of Dermatology (AAD) 2. Kreftregisteret 2001

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, Photo. Cure’s licencing partner, and in the Nordic countries by Photo. Cure

The Metvix procedure - easy and effective Lesion preparation Metvix application Aktilite illumination

A strong pipeline within PDT in clinical phase

Acne - need for new treatments Competitor Segment Isotretinoin (eg. Roaccutan) Oral Antibiotics Acne patient before treatment Oral Vitamin-A Oral Antibiotics Therapeutic modalities • • Highly effective Long term treatment Severe side effects Risk management program US/EU • Moderate effect • Long term treatment • Resistance issues

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 - PCI Biotech is a subsidiary of Photo. Cure. - PCI is a light-directed drug delivery technology - developed to introduce therapeutic molecules in a biologically active form specifically into diseased cells. Light M S M M S S S + light S* M M S S M S photochemical reactions

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 n Member of management team – Influence on Photo. Cure’s way forward - future projects, organisation, resource allocation n Responsible for marketing and sales in Photo. Cure, 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 n Cooperation with international licence partners (Galderma, GE Health. Care) – 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 forskning, utvikling, og produksjon av Drug Products n 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) n 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 n Kliniske programmer for nye substanser eller nye indikasjon n Kliniske undersøkelser innen – Farmakokinetikk, Farmakologi, Effekt, Bivirkninger and Qo. L n Gjennomføre selv / outsource studier – protokoll (Design / metodologi etc. ) – pasientskjemaer – søknader og monitere – data håndtering og statistikk – rapportere og publisere n Registrering klinisk dokumentasjon (strategi, møter f. eks EMEA / FDA) n Prosjektarbeide; Kjemi / farmasi / patent / preklinikk n Relasjonsbygging - sykehus, apotek, CRO, laboratorie, partner m. fl. n Markedsanalyser; Presentasjoner møter / kongresser; Budsjett

Sylvia Vetrhus – Clinical Trial Manager (CTM) Marianne Sletsjøe - CTM and Safety Officer n Clinical studies n Regulatory – clinical documentation n Quality Assurance and SOPs n 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)

Photo. Cure ASA n Farmasøyter med varierte arbeidsoppgaver n ”Strong pipeline” – nye spennende prosjekter innen onkologi og dermatologi n Relativt lite forskningsbasert firma n Jobber på tvers av ”avdelinger” - sitter i åpent landskap n ”Outsourcing” – utstrakt internasjonalt samarbeid med forskningsinstitusjoner/ partnere / konsulenter n www. photocure. no