CHICAGO--Novo Nordisk ($NVO) has begun to regroup from one of the biggest regulatory setbacks of the year. In February the FDA dealt the Danish drugmaker a major blow in denying approval of its blockbuster hopeful, Tresiba, seeking cardiovascular outcomes data on the long-acting insulin that will delay the U.S. launch of the drug by several years.
The rejection reaffirmed the agency's earned squeamishness about any signal of cardio dangers from diabetes drugs and gave Novo Nordisk's archrival Sanofi ($SNY) a reprieve from U.S. competition to its own long-acting insulin Lantus. In fact, Sanofi has a shot to introduce a next-gen version of Lantus called U300 on the U.S. market before Tresiba ever arrives here.
The gnarly Tresiba situation makes Mads Krogsgaard Thomsen, Novo's chief of R&D, an interesting source of views on the safety requirements on diabetes drugs from the FDA and the rabid competition his company faces in the diabetes field. And at the annual American Diabetes Association (ADA) meeting here in Chicago, major pharma players have reported new data to highlight their contenders in the GLP-1 drug class where Novo's Victoza enjoys blockbuster status.
"There is no doubt that the FDA has this safety-first principle. They have publicly stated that," Thomsen said in an interview with FierceBiotech. "Which relates to [CDER chief] Janet Woodcock and her various divisions wanting to avoid, you can argue, future drug scandals. Because every time it falls back on the agency, so obviously they are very cautious. Whether they are even more cautious is difficult for me to say."
FDA reviewers were clearly more cautious than their counterparts from the European Union and Japan, where Tresiba and a related combo product Ryzodeg won approvals over the past year. Thomsen said that his company's latest estimate on arrival of the next-gen insulin on the U.S. market is sometime between 2016 and 2017. Ouch.
|Mads Krogsgaard Thomsen|
Yet he gave the FDA a nod to the "science-driven" approach that the agency took in doing toxicology studies involving the incretin drugs Byetta and Januvia from Bristol-Myers Squibb ($BMY)/AstraZeneca ($AZN) and Merck ($MRK), respectively. Those studies have helped counter concerns about an increased risk of pancreatic cancer from those products.
Victoza, which is also an incretin mimetic in the GLP-1 class, was not included in the FDA studies about the cancer risk, Thomsen said. In their efforts to unseat the drug as a top choice in the class, however, Novo's diabetes rivals have mounted efforts to show how their GLP-1 contenders can beat the glucose-lowering effects of Victoza. So far, Victoza has emerged victorious from trial showdowns with Byetta, Sanofi's Lyxumia and GlaxoSmithKline's ($GSK) albiglutide, he noted.
But Victoza might get a butt kicking from the new kid on the block. Eli Lilly ($LLY) has reported results from at least three late-stage trials of dulaglutide, a once-weekly GLP-1 therapy that analysts view as a competitive threat to Victoza. Dulaglutide edged Bristol-Myers' Byetta, Merck's Januvia and metformin in lowering glucose levels in the Phase III trials. An ongoing study from Lilly pits dula' head-to-head with Victoza.
A Bank of America analyst gave dula' an early edge over Victoza after viewing the ADA data abstracts last week, and the big bank slashed peak sales projections for Victoza from $3.76 billion to $2.15 billion, Bloomberg reported.
Thomsen acknowledged that the dula' data show glucose-lowering effects "on par" with Victoza, but he said that Victoza could offer better reductions in weight and blood pressure. Yet the dula-versus-Victoza study should spell out the differences between the drugs more definitively.
Novo, which has way fewer presentations on the agenda than Sanofi and Lilly at the ADA congress, has highlighted upbeat results from a Phase III study of the company's Victoza-Tresiba combination product called Ideglira. With this experimental combo, Thomsen sounded confident in its superiority over rivals.
"When I look at combination products, Ideglira is in class of its own compared to, for instance, the combination product we know Sanofi's working on, where they have not yet started Phase III," Thomsen said. "Where both Victoza is much more longer acting and powerful than Lyxumia, and Tresiba is twice as strong and more predictable than insulin glargine [Lantus]."
"So when you combine the two," Thomsen added, "you obviously get a more powerful product than when you combine the two other [drugs], and this is consistent with the data that have been reported at this conference."
Though years away from prime time, Novo has been investing 1 billion Kronar a year in research of several oral insulin and GLP-1 products that could make the therapies available to many patients who prefer even less effective oral drugs to avoid injections, Thomsen said. Those candidates are in a slate of Phase I studies, yet they offer some promise to become hot topics during future ADA meetings. -- Ryan McBride (email | Twitter)
Editor's note: This edit changed the classification of "incretin mimetics" to "incretin drugs" to clarify the differences between GLP-1 and DPP-4 drugs.