pdf 360 KB - ReAct

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pdf 360 KB - ReAct

Development of new antibiotics- the industry perspectiveRichard BergströmDirector General, EFPIAReAct seminar in EP29 March 2011


The dwindling antibiotic pipeline...TrimetoprimStreptograminsQuinolonesChloramphenicol LincosamidesTetracyclinesMacrolidesGlycopeptidesSulphonamidesAminoglycosidesPenicillinsLipopeptidesOxazolidinones1930´s 1940´s 1950´s 1960´s 1970’s 1980´s 1990´s 2000´s2


Two (three) problems• Scientific challenges• Current business model not working• (Unreasonable regulatory requirements, incl.by payers)3


% Probability of success at each stepHTStoLeadLead optimizationto DevelopmentCandidate (DC)DCtoPh 1startPh 1toPh 2startPh 2toPh 3starttoPh 3FileFile toLaunch*NovelAntibacts:#Industryaverage (alltherapeuticareas)2yr 3-5yr 1yr 1yr 2yr 2yr 1yr7% 50% 50% 33% 50% 67% 25%80% 85% 69% 54% 34% 70% 91%IndustryAverages70 HTSgave 5LEADS6 of 11 novel MoACandidatesreached Ph1Estimate 2 of 6to Ph2 start1 of 4 filessuccessful inlast 18M*Hit to Phase 2 starts based on GSK data. Phase 2 and Phase 3 success based on Centers for Medicines Research(CMR) 2003 averages for antibacterials (likely based on agents from established classes). #Paul, et al 4 (2010).Nature Reviews Drug Discovery 9: 203-214.


Why is this so difficult?• ”These guys have been around longer than us. Andthey are a few more…And they are built to survive”• Most antibacterial targets are enzymes (not receptors)• Enzyme targets hard to inhibit• Bacterial enzymes had billion years longer to evolverefractory active sites• Compound libraries biased towards attributes suitedfor mammalian targets• Antibacterial targets need different types of chemicaldiversity5


Current thinkingOn research:• New collaborative models needed (incl. open soureand pre-competitive pooling)• Role for PDPs• New approach by regulators and payersOn the business model:• New incentives that reward new priority antibiotics(intelligent push and pull)• De-linking revenues from sales; responsiblemarketing, or none at all• Global compact on usage, pricing and access• Going forward: focus on the future; use new resourceswisely6


A global compact• Mechanism for designation of priority antibiotics• Incentive schemes at regional (EU, US) and globallevel• Regulatory and payer requirements and processesaligned• Scheme for equitable access and affordable pricing• Once approved: agreed and controlled use• Distribution controlled ?• Certificied prescribers/clinics ?• To discuss: will this work in practice (eg India, Brazil,China)?7

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