New Citeline trial density analysis provides insight into robustness of pharma pipelines.
According to a new report in the July issue of Good Clinical Practice Journal (GCPj) Novartis leads the field for ongoing trials in autoimmune, cardiovascular, and metabolic diseases while Sanofi-Aventis is number one for ongoing oncology trials.
The new Expert Analysis article published in GCPj, by Tracy DeGregorio and Christine Blazynski examines the robustness of leading pharma and biotech pipelines with respect to ongoing clinical trials activity. They conclude that trial density is a particularly good indicator of the depth of companies' pipelines and focus of development efforts.
The report, considered the focus of analysis, specifically ongoing, industry-sponsored clinical trials for 20 leading pharma and biotech companies across six major therapeutic areas.
Tracy DeGregorio, co-author of the report, looked at the numbers of total ongoing trials by company, by therapeutic area and by development phase, with some interesting findings. "Sanofi-Aventis, Novartis and GlaxoSmithKline, for example, all have more ongoing clinical trials than Pfizer, despite spending over US$1 billion less per year in R&D. Genentech also seems to be a success, with its number of ongoing trials rivaling that of companies twice its size in both revenue and R&D spending."
In a detailed analysis of companies by ongoing trial activity across six therapeutic areas (autoimmune/inflammation, cardiovascular, CNS, metabolic, infectious diseases, and oncology), those companies spending in excess of US$4 billion in R&D hold most of the top three positions across the six therapeutic areas with the exceptions of Genentech (second in ongoing oncology trials), and Takeda (third in ongoing metabolic trials). In the case of Novartis, trial density is particularly strong, securing the top rank in autoimmune, cardiovascular, and metabolic diseases.
According to co-author, Dr Christine Blazynski, "Ongoing trial activity is also particularly useful in examining the distribution of early-stage vs late-stage pipeline health. Looking at early-stage activity, for example, for several companies, fewer than 20% of their total ongoing trials are in either Phase I or I/II, including Takeda, Boehringer Ingelheim, Novo Nordisk, Eli Lilly, Abbott and Sanofi-aventis. The companies with robust early-stage programmes, those with greater than 35% of total trials in Phase I or Phase I/II, include Merck Serono, Wyeth, AstraZeneca, GlaxoSmithKline and Schering-Plough."
Density of trial activity around a particular candidate also unmasks companies' strategies to either disrupt an established market to steal market share, or enter smaller markets with large unmet need. As an example, this report looked at the distribution of industry-sponsored trials by tumour type for the three approved EGFR inhibitors: Erbitux, Iressa and Tarceva.
"Trial density provides an extremely valuable metric for both broad assessments, such as a company's strength in a therapeutic area, as well as for granular analyses, like examining specific development strategies by drug, disease, target patient population, or mechanism of action," concludes DeGregorio. "It should always be taken into consideration."
Keywords : Citline, Expert Analysis, Good Clinical Practice journal (GCPj), Clinical trials activity, Pharma pipeline, Trial denisty, R&D, Novartis, Sanofi-Aventis, GSK, Pfizer, Genentech, Takeda, Novo Nordisk, Eli Lilly, Boehringer Ingelheim, Abbott, Merck Serono
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