Download PhotoCure AS Goals

PhotoCure ASA
Presentation of
Licensing agreement for Metvix PDT
with Galderma S.A.
Oslo December 2001
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Disclaimers
„ This document includes forward-looking statements. These statements are
based on current expectations and projections about future events. Actual
results could differ materially from those discussed in, or implied by, these
forward-looking statements.
„ This document does not constitute or form part of any offer for sale or
subscription of or solicitation or invitation of any offer to buy or subscribe for
any securities nor shall it or any part of it form the basis of or be relied on in
connection with any contract or commitment whatsoever.
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2001;- The Year to be Remembered
„ Metvix®, PhotoCure’s first launched product:
– Launched for AK & ”High Risk” BCC in 1st EU country (Sweden)
– AK and “High Risk” BCC approved in EU
– MAA pending in US, Australia & New Zealand
– Market partner outside Nordic area
„ Hexvix® development program on track:
– Hexvix® phase II study for bladder cancer detection finalised
- Hexvix superior to standard white light cystoscopy in detecting bladder
cancer
– Hexvix® phase III studies initiated
„ PCI Biotech AS established
– First product for the research market close to launch
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Metvix®
– quick and simple treatment
Lesion preparation
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Metvix® application
Curelight illumination
Metvix® market opportunities
„ BCC
– Appr. 2 mill. new cases per year in EU, America & AUS
– Current therapies give disfiguration / morbidity
„ AK
– Appr. 20 mill. new cases per year in EU, America & AUS
– Current therapies give scar & white spots or poor patient
compliance
„ Dermatologists view Metvix® as a real improvement
– Easy to use (fast, not time consuming)
– Additional medical indications
– Practice builder (less referral to surgeons)
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Licensing agreement for Metvix®
„ Marketing and sales
– Galderma will promote Metvix & CureLight world wide outside the
Nordic area
„ Regulatory approvals
– PhotoCure will be responsible for MAA in EU, US, AUS and NZ
– Galderma will file MAA’s in other countries
„ Manufacturing
– PhotoCure will manufacture Metvix and CureLight
– Galderma will after the initial period be responsible for the
production of Metvix
– PhotoCure will continue to manufacture the active ingredient
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Metvix® licensing agreement
– Financial terms
„ Up front payment of 12 mill Euro
„ Regulatory Milestones: 18 mill Euro
– Linked to regulatory approval in US and launches in US and two other
major countries
„ Sales milestones
– For global sales level of 25 mill Euro per year and above
„ Royalties for existing and new indications
„ Payments for manufacturing
– Metvix
– Active ingredient
– CureLight
„ Significant guaranteed minimum payment of royalties & sales milestones
– During first 5 years after US approval
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Metvix® licensing agreement
– Research & Development
„ A collaboration on PDT in dermatology
„ Galderma will fund 75% of agreed upon development costs
„ Galderma will pay additional milestone payments for approval of new
indications
„ Both companies see several possible new indications
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Potential new indications
Metvix® offers product life cycle management:
„ Inhibitory effect on pilosebacious units
– Acne (pilot study ongoing)
– Oily skin
„ Anti-wrinkles
– Photoaging (Skin rejuvenation)
„ Anti-microbal
– Wound healing (pilot study planned)
„ Anti-viral
– Warts
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Metvix® overview
„ Metvix® is approved in the 14 European countries for AK & BCC
„ Metvix® gives excellent results in AK & BCC:
– High cure rate
– Superior cosmetic outcome
– Preferred by the patients
„ Unmet medical need for a non-invasive product with excellent
cosmetic outcome
„ Metvix® is being tested for other indications
„ Long patent life (expires in 2016+)
„ Sales force established in Nordic countries
„ Dedicated partner established outside of the Nordic countries
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