The changing face of pharma industry research

Transcription

1 BSAC - The UK Roundtable Series, Feb 2015 Re-stoking the therapy pipeline: How to stimulate the development of new antibiotics, diagnostics and novel therapies The changing face of pharma industry research U. Theuretzbacher Center for Anti-Infective Agents, Vienna, Austria

2 The antibiotic era Small spectrum Broad spectrum Small spectrum Small spectrum Gram positive Gram negative Gram positive Gram negative Gram positive targeted s s 2000s 2010s Golden years of pills and profits Fixing selected resistance problems Natural products Medicinal chemistry, Semisynthetic products Target based Natural products? Alternative approaches? MS Kinch et al: Drug Discovery Today 2014, 19 (9)

3 The antibiotic era MS Kinch et al: Drug Discovery Today 2014, 19 (9)

4 The changing face of the pharmaceutical industry Big Pharma Discovery and research activities Small companies, biotech acquisitions Marketing companies Expertise time

5 Antibiotics R&D Compound Class Discovery of class Fail at FDA Pass at FDA Linezolid Oxazolidinone Ertapenem Carbapenem Cefditoren Cepahlosporin Gemifloxacin Fluoroquinolone Daptomycin Lipopeptide Telithromycin Macrolide Tigecycline Tetracycline Faropenem Penem Retapamulin Pleuromutilin Doripenem Carbapenem Cethromycin Macrolide Iclaprim Trimethoprim Telavancin Glycopeptide Ceftaroline Cephalosporin Fidaxomicin Macrocyclic Dalbavancin Glycopeptide Oritavacnin Glycopeptide Modified: L Silver 2011 Ceftobiprole Cephalosporin (EU) Tedizolid Oxazolidinone

6 Innovation gap and discovery void L. Silver 6

7 Where is the innovation coming from? Ceftobiprole (Zevtera) Roche * Basilea Dalbavancin (Xydalba) Vicuron Pfizer Durata Actavis Oritavancin (Orbactive) Eli Lilly * Intermune Targanta The Medicine Company Tedizolid (Sivextro) Dong-A Trius Bayer/Cubist=Merck Ceftolozane+tazobactam (Zerbaxa) Astellas Calixa Cubist=Merck Ceftazidime+avibactam Sanofi * Novexel AstraZeneca-Forest/ Actavis Omadacycline Paratek Novartis (colll. discontinued) Solithromycin, oral, iv-oral Optimer Cempra Paratek approved Ph 3 Delafloxacin, iv, oral Wakunaga Abbott Wakunaga Rib-X (Melinta Therapeutics) TP-434 (=eravacycline) Harvard University Tetraphase Plazomicin Isis Achaogen Carbavance?? Rempex The Medicines Comp. Nemonoxacin (appr. Taiwan) TaiGen Procter & Gamble Warner Chilcott TaiGen Radezolid Yale University Rib-X =Melinta Therapeutics BC-3781 (Lefamulin) Sandoz/Novartis * Nabriva Forest/Actavis Nabriva JNJ-Q2 (Avarofloxacin) J&J (Janssen Pharm.) * Furiex Forest/Actavis Ph 2 PMX (Brilacidin) Polymedix bankrupt Cellceutix Corporation AFN-1252/Debio 1450 University of Toronto Affinium Debiopharm POL7080 Polyphor Roche University/SME Large company (>500 emploees) Global pharmaceutical corporation * More than 10 years ago 7

8 Complex R&D network Integrated Pharma Company: discovery development marketing worldwide Univ. SME Pharma Process manufact SME CRO in vitro CRO in vivo CRO clinical SME Market. contract Big Pharma Medium Pharma Out-licence Territory

9 Financing antibiotics R&D Integrated Pharma Company: internal investment Revenue from other sources Charity Angels Loans Crowd funding Public SME Venture capital IPO????? Collaborations Corporate VC

10 Antibacterial drug R&D in Europe SME: Focus of activities No companies Antibacterial drugs: Small molecules, peptides, vaccines, anti-virulence, antiresistance, adjunctive; systemic, topical Sm mo = small molecule 10

11 Antibiotics R&D - Incentives Incremental vs game changing Different players and different phases of R&D What do we need? Target product profile! Discourage volume based ROI Controlled global access

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