Like Eli Lilly ($LLY) and Boehringer Ingelheim, Danish drugmaker Novo Nordisk ($NVO) has a closely watched long-acting basal insulin in development that stands out from the rest of its pipeline. The company was stymied with two delays in the FDA's review of the therapy, called Tresiba, or NN1250, as the agency sought more time and then called for an advisory committee panel on the application slated for next month.
Novo, one of the world's biggest insulin producers, last month won approval of Tresiba in the smaller Japanese market. Yet the U.S. market green light is key to the company's planned expansion in the world's largest healthcare market, where it's been recruiting commercial and research workers this year. The U.S. commercial organization will likely have to wait until next year before a potential launch of the new insulin therapy if approved by the FDA. Then the company can begin to compete with Lantus in the long-acting insulin category so prized among players in the field.
Meantime, Novo has worked on building its position in the market for GLP-1 drugs. The company quickly took market share from Amylin's Byetta with the 2010 release of its rival product Victoza in the U.S., yet Amylin fought back with an extended-release version of Byetta called Bydureon. Novo's counterpunch is a weekly GLP-1 analog injection called semaglutide, or NN9535, in late-stage development. It's also working on a Victoza/Tresiba combo product, dubbed IDegLira, in the third phase of trials.
Yet in terms of R&D focus, nobody's pipeline resembles Novo's as closely as Lilly's slate of candidates. And Novo R&D chief Mads Krogsgaard Thomsen is paying close attention. "My eyes are clearly on what Lilly is doing," he told Bloomberg in a recent interview, "because they are the ones that have a pipeline in our area of R&D, unlike others."
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Drug: Tresiba (NN1250)
Phase: Under FDA review/approved in Japan
Partner: Zealand Pharma A/S