farmasøytisk fagdag 8. mai 2006 photocure asa leadership in photodynamic therapy
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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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M
S
S
S
S
S MM
M
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S
SS M
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MMM
MS
S
SS
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
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