The anticancer drug development pipeline of the pharmaceutical (P) and biotech (B) industries
e14589 Background: The rapidly growing market for anticancer drugs has attracted numerous companies, and this therapeutic area represents more that a third of all drug development candidates. We studied the pipeline of Pharma (P) and Biotech (B) companies to look at possible differences and 2008 changes in composition. Methods: The anticancer drug pipeline including candidates in Phase I to III and marketed products still actively developed in new indications was reviewed by systematically searching the websites of 41 P and 269 B active in oncology. Results: B, defined as entrepreneurial R&D-focused companies had 463 molecules including 160 in Phase I, 202 in Phase II, 73 in Phase III, and 28 marketed. P develop 219 molecules including 78 in Phase I, 61 in Phase II, 38 in Phase III, and 42 marketed. The number of candidates decreased by 10 in B and increased by 15 in P pipelines during H2, 2008, translating difficult economic conditions for B (with few candidates entering Phase I) and an increased focus of P on oncology (internal R&D efforts and B acquisition that accounts for 39 of its 219 molecules). B licensed out 119 of its candidates to P or other B. The portfolio of B and P analyzed by mechanism of action significantly differs. Symptomatic/adjuvant treatments represent 7.1 vs 5.5%, targeted small molecules 28.7 vs 42.9%, cytotoxics including reformulations 20.5 vs 22.4%, cell/gene therapies, oncolytic viruses, and oligonucleotides 7.3 vs 0%, antibodies and related proteins 19% vs 17.8%; immunotherapy 13.1% vs 5%, photodynamic and radio- therapy 2.8% vs 0.5% for B vs P, respectively. The number of antibodies and targeted small molecules increased during H1, 2008 by 2.1 and 4.4%, respectively. P recently enriched its antibody portfolio through B acquisition, but completely moved out of cytotoxics, except mid-size European and Japanese P. An update as of May,1st 2009 with a trend analysis including the potential impact of the financial crisis on B portfolio will be presented. Conclusions: The oncology pipelines of P and B are broad, different for B and P, and rapidly changing in composition. No significant financial relationships to disclose.