Scoping the pipeline

Why are certain categories of drugs or mechanisms of actionso interesting or so promising? What factors influence their chance forsuccess?

Since 2006, people have been getting answers to thesequestions and more from "The Ones to Watch," a quarterly report produced byThomson Reuters. Based on the strategic data and insight of the company'sCortellis for Competitive Intelligence system, the report lists and analyzesthe most promising drugs of the quarter, covering changes in clinical phases,approvals and launches. It begins with an introduction that summarizes keytrends for the quarter and then has four sections: one that describes the fivemost promising drugs to be approved or launched in the quarter, and three thatdescribe the five most interesting drugs to enter each of Phases III, II and Iof clinical trials.

"What makes the drugs interesting is that they are new andup-and-coming in the R&D arena, that a new technology platform has beenused to bring them to the clinic, that they have beaten the odds and reachedPhase III in the approval process or that they have the most sales potential orwill make the most money when they are launched," says Saloni Shah, managingeditor of the five-member news team that creates the report after trackingwhich drugs have changed phases, gotten approved or gotten launched. "Otherfactors might be that the drug platforms are combinations that offer more thansingle-agent drugs or that the drugs have been on the market for one usage andare moving through clinical trials for another."

Using the Cortellis system—which was designed and optimizedto deliver knowledge quickly and easily for putting together a pipelineanalysis, developing a comprehensive competitive intelligence study or planningfor pre- and post-launch regulatory strategy—the team also looks at whicharenas of drug discovery have been active in a given quarter.

"We look at the market, what is interesting about theparticular drugs and what mechanisms make them work and then create thereview," Shah explains.

For instance, in the most recent report, which coversJanuary through March, the market related to diabetes is well represented, andthe report provided reasons for the trend. Novo Nordisk's Tresiba, anext-generation, ultra-long-acting, once-daily basal insulin analog for thetreatment of type 1 diabetes and type 2 diabetes, was launched during the firstquarter in Japan and Europe. Sanofi's Lyxumia, a subcutaneous GLP-1 andexendin-4 analog for the treatment of type 2 diabetes, was launched underlicense from Zealand Pharma. The topical agent DSC-127 from Derma Sciencesentered Phase III clinical testing for the treatment of diabetic foot ulcers.

Another highlighted topic is the Exelixis orphan drugCometriq, an oral inhibitor of multiple tyrosine kinases for patients withprogressive, metastatic medullary thyroid cancer, recently approved underOrphan Drug and Priority Review designations. In the category of breakthroughtherapy, the report cited Phase III trials for Vertex/Cystic FibrosisFoundation Therapeutics' lumacaftor plus Kalydeco, a fixed-dose combination fortreating cystic fibrosis.

"The Ones to Watch" is part of the company's Pharma Mattersseries 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 atThomson Reuters. All of the reports are available free of charge to anyone whowants to download them from Thomson Reuters' website at www.thomsonreuters.com.

Such reports are especially critical because of variousfactors affecting the pharmaceutical and biotechnology industries, according toShah.

"Pharma companies have faced the patent cliff withblockbuster drugs coming off patent, leading to generic competition, and thus,the need to add new blockbusters to the pipeline," she says. "In the biotecharena there is a challenge to compete with biosimilars."

Another key factor is the financial crisis that has loomedlarge all over the world since 2008. As Shah notes, "In Europe, drug companieshave to work with public health providers with finite budgets, but they stillhave to make a profit and patients still need to get drugs."

People who utilize the reports range from "businessdevelopment professionals in biotech and pharma who want to scout theircompetitors and learn about research to scientists who want to know whatresearch is making the most headway across the R&D cycle," Shah adds. "Inorder to make the best decisions, they're looking for the analytical skills anddepth we provide from maintaining research on an ongoing basis and continuouslyadding content from a wide variety of sources."