Spring Intro 2023

03/03/2023

LCM - adding value to established products

Additional indications, manufacturing sites, forms, strengths, delivery devices ● Grow Brand (e.g. Enbrel in EU $0.1B to $1.4B from 2001 to 2005) ● Extra data exclusivity/protection (sig indication+1 year, PIP +6 months Supp Patent Cert) ● Maintain profile in disease area/management

To maintain income at time of patent expiry ● Introduce new indication tied to new patentable formulation ● New patentable formulation offeringmedical or commercial advantage

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Lack of Harmonisation – ICH (?)

Different standards of medicine in the US, Europe and Japan complicate clinical trials: ● Choice of comparators: US-placebo; EU-comparator drug and placebo ● EU is not one country; which comparator? ● Comparative effectiveness and social need must now be established for new drug (EU, US?); no longer just quality, safety and efficacy ● Support pricing strategy with clinical trial data ● Differing expectations for risk/benefit (US “substantial evidence of efficacy” EU “Positive benefit:risk”) ● Clinical Trial Regulation - EU regulations harmonized but Ethics? ● Japan - Japanese monkey study request???

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