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Scoping the pipeline
Why are certain categories of drugs or mechanisms of action so interesting or so promising? What factors influence their chance for success?
Since 2006, people have been getting answers to these questions and more from "The Ones to Watch," a quarterly report produced by Thomson Reuters. Based on the strategic data and insight of the company's Cortellis for Competitive Intelligence system, the report lists and analyzes the most promising drugs of the quarter, covering changes in clinical phases, approvals and launches. It begins with an introduction that summarizes key trends for the quarter and then has four sections: one that describes the five most promising drugs to be approved or launched in the quarter, and three that describe the five most interesting drugs to enter each of Phases III, II and I of clinical trials.
"What makes the drugs interesting is that they are new and up-and-coming in the R&D arena, that a new technology platform has been used to bring them to the clinic, that they have beaten the odds and reached Phase III in the approval process or that they have the most sales potential or will make the most money when they are launched," says Saloni Shah, managing editor of the five-member news team that creates the report after tracking which drugs have changed phases, gotten approved or gotten launched. "Other factors might be that the drug platforms are combinations that offer more than single-agent drugs or that the drugs have been on the market for one usage and are moving through clinical trials for another."
Using the Cortellis system—which was designed and optimized to deliver knowledge quickly and easily for putting together a pipeline analysis, developing a comprehensive competitive intelligence study or planning for pre- and post-launch regulatory strategy—the team also looks at which arenas of drug discovery have been active in a given quarter.
"We look at the market, what is interesting about the particular drugs and what mechanisms make them work and then create the review," Shah explains.
For instance, in the most recent report, which covers January through March, the market related to diabetes is well represented, and the report provided reasons for the trend. Novo Nordisk's Tresiba, a next-generation, ultra-long-acting, once-daily basal insulin analog for the treatment of type 1 diabetes and type 2 diabetes, was launched during the first quarter in Japan and Europe. Sanofi's Lyxumia, a subcutaneous GLP-1 and exendin-4 analog for the treatment of type 2 diabetes, was launched under license from Zealand Pharma. The topical agent DSC-127 from Derma Sciences entered Phase III clinical testing for the treatment of diabetic foot ulcers.
Another highlighted topic is the Exelixis orphan drug Cometriq, an oral inhibitor of multiple tyrosine kinases for patients with progressive, metastatic medullary thyroid cancer, recently approved under Orphan Drug and Priority Review designations. In the category of breakthrough therapy, the report cited Phase III trials for Vertex/Cystic Fibrosis Foundation Therapeutics' lumacaftor plus Kalydeco, a fixed-dose combination for treating cystic fibrosis.
"The Ones to Watch" is part of the company's Pharma Matters series that "surrounds the drug discovery arena from R&D to clinical trials" and also includes "Cutting Edge of Chemistry," "Movers and Shakers" and "Spotlight On," explains Michael Passanante, director of strategic marketing at Thomson Reuters. All of the reports are available free of charge to anyone who wants to download them from Thomson Reuters' website at www.thomsonreuters.com.
Such reports are especially critical because of various factors affecting the pharmaceutical and biotechnology industries, according to Shah.
"Pharma companies have faced the patent cliff with blockbuster drugs coming off patent, leading to generic competition, and thus, the need to add new blockbusters to the pipeline," she says. "In the biotech arena there is a challenge to compete with biosimilars."
Another key factor is the financial crisis that has loomed large all over the world since 2008. As Shah notes, "In Europe, drug companies have to work with public health providers with finite budgets, but they still have to make a profit and patients still need to get drugs."
People who utilize the reports range from "business development professionals in biotech and pharma who want to scout their competitors and learn about research to scientists who want to know what research is making the most headway across the R&D cycle," Shah adds. "In order to make the best decisions, they're looking for the analytical skills and depth we provide from maintaining research on an ongoing basis and continuously adding content from a wide variety of sources."