Novo chief Sorensen preps for showdown as Lilly's dulaglutide nears diabetes market

COPENHAGEN--The executive team here at the rapidly expanding headquarters of Novo Nordisk doesn't pull many punches. CEO Lars Rebien Sørensen is a competitive sort who tends to be blunt, aggressive and forward-thinking, projecting a confident attitude that is reflected by the rest of the execs and right down the line to 40,000 rank-and-file employees around the world. 

So when Sørensen gives a (slightly grudging) thumbs up to a rival diabetes drug developer like Eli Lilly ($LLY), the assessment carries a lot of weight.

"I think it's a good product," the CEO says of Lilly's late-stage GLP-1 drug dulaglutide, now under FDA review. The rival treatment is "slightly inferior to Victoza" on blood sugar and weight, he adds in an interview with FierceBiotech, but he's clearly bracing for a competitive showdown, even as other rivals barely warrant a mention. 

Novo Nordisk ($NVO) has 5 of the top 10 diabetes treatments and a rising market valuation that has now surpassed a struggling GlaxoSmithKline ($GSK). But when Lilly announced recently that its once-weekly treatment proved "non-inferior" to the once-daily Victoza, analysts quickly began buzzing about the likely competitive pressures that would arise as patients were offered an alternative to Victoza with an easier dosing schedule.

Novo Nordisk execs are acutely aware of the market position they're in. The FDA dealt the company a blow when it blindsided Sørensen's team with a demand early last year for a massive new study to examine Tresiba's impact on the cardiovascular system, even as the EMA green-lighted the long-acting insulin and now appears ready to follow up with an OK on a combination of Tresiba and the best-selling Victoza. 

In diabetes drug development, which requires thousands of patients and years of study in late-stage trials, Novo is always focused on the next big finish line. And a few days ago the company noted that its ability to speed up recruitment combined with a faster pace of cardiovascular events required to complete the study would allow the company to do an interim analysis toward the end of this year, setting up a new application in 2015 and a prospective market launch in early 2016.

Lars Rebien Sørensen

In the meantime, Novo is bracing for the arrival of dulaglutide, expecting a new GLP-1 drug will add fresh attention and help expand the market for this drug class, but also preparing to see the market carved up in new ways. 

In Sørensen's estimation, Victoza will be left with about 50% of the GLP-1 market, with Lilly commanding roughly 30% and GlaxoSmithKline (with the newly approved albiglutide) and AstraZeneca ($AZN, Bydureon) splitting the remaining 20%--with distinctly inferior products.

But there's a catch. Sørensen is a "firm believer" that patient compliance is better with a once-daily therapy compared with a once-weekly treatment, which also has some side-effect complications that could slow adoption.

Novo's research group is excited about their once-weekly candidate, he adds, but diabetics tend to be loyal to a product once they begin to treat themselves with a drug and grow increasingly comfortable with its use, and that should help protect Victoza's market share--for now. 

Market share is vitally important for Lilly. After a years-long drought of major new drug approvals, the pharma giant desperately needs to introduce blockbuster products as its mainstays are decimated by generic competition. And dulaglutide is definitely its best hope to make a mark this year.  

The game plan at Novo, meanwhile, is to go after the FDA's approval for Tresiba on the interim analysis--provided the statistics provide regulators with the reassurance they're looking for. Then the company plans to immediately follow up with a combination of Tresiba and Victoza.

"We don't want to confuse the agency," says the CEO. If Novo filed the combo ahead of a Tresiba OK, the FDA would just put it on hold until they finished with the solo application. If they get an OK on the combo, he adds, then Novo will control "the two best products in their class." 

Novo should then be in a position to launch its own once-weekly GLP-1 drug, semaglutide, in the 2017/18 time frame. And further down the pipeline the company has oral products in the works, including an oral insulin that could dramatically improve treatment for millions of new patients around the world.

"I think dulaglutide will do well," says Mads Thomsen, the chief scientific officer, in a separate conversation with journalists. There should be a substantial market for both the weekly and daily drugs, he adds. And then there are high hopes that Novo's Phase III program for semaglutide will come out on top of Victoza, sewing up its top position in the GLP-1 class as investigators hurry along oral therapies.

"Semaglutide has seen more weight loss and more glucose lowering than Victoza," says Thomsen.

Just don't look for Novo to go after an inhaled insulin again.

"We still have scars on our back for trying to develop our own," says Sørensen with a rueful smile.

Pfizer's ($PFE) progress with Exubera in the clinic spurred Novo to develop its own inhaled insulin treatment. But the company dropped it once Exubera flopped and the competitive pressure was removed. And Novo wasn't enticed by MannKind's ($MNKD) Afrezza--or feeling much threatened by it. Novo, like the other players in the field, had plenty of chances to partner on the newly approved Afrezza, but the company passed on a pact and never remounted an R&D offensive for a rival. And that's a telling point in a field where every promising category tends to attract the full flock of major players angling for a share of this megablockbuster market.

Now Sanofi ($SNY) is signed on to market Afrezza, paying a bargain-basement rate of $150 million upfront to get into the game. But Sørensen notes there's still a big price tag attached to the next big study required by the FDA.

Inhaled insulins like Afrezza are taken at mealtime, used as a supplemental treatment to currently used injectible basal insulins. "They already inject themselves with basal insulin."

For Sanofi, it's like they're "counterdetailing basal insulin starts." And Sørensen shows little interest in jumping in.

At least for now, Novo also believes it can continue to command a premium price for Victoza, unrattled by a challenge from U.S. pharmacy benefit managers, some of which are getting aggressive on formularies.

Says Sørensen: "Victoza is such a superior product we don't want to discount it." -- John Carroll (email | Twitter)

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