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ADA report. What’s next in diabetes drugs? The pulse of R&D at ADA 2014

 

”Those numbers are just unfathomable,” Eli Lilly’s ($LLY) diabetes president Enrique Conterno said. ”It’s a significant problem and a significant epidemic,” he said, and one the global drug development is racing to help control. United Healthcare expects the cost of diabetes care to reach $500 billion by 2020 in the U.S. alone, providing plenty of motivation for the makers of tablets, shots, insulins and medical devices designed to control blood sugar and save lives.

Convening in San Francisco for the annual conference of the American Diabetes Association this weekend, Big Pharma angled for the spotlight in a field made up mostly of similar treatments with small differentiations that could spell the difference between blockbuster sales and also-ran status.

Much of the debate has focused on two newfangled treatment models: Injectable therapies that have shown big benefits but are yet to make a splash among doctors, and oral drugs that come with noteworthy efficacy but some alarming risks.

A promising new class

GLP-1 drugs at a glance

AstraZeneca’s exenatide

Regulatory status: Approved in 2005 as daily Byetta and in 2012 as weekly Bydureon
2013 sales: $555 million combined
Peak estimate: Up to $1.3 billion combined

Novo Nordisk’s liraglutide

Regulatory status: Approved in 2010 as daily Victoza
2013 sales: $2 billion
Peak estimate: Up to $3 billion

Sanofi’s lixisenatide

Regulatory status: Approved in Europe in 2013 as daily Lyxumia; FDA application expected in 2015
2013 sales: $12 million
Peak estimate: Up to $900 million

GlaxoSmithKline’s albiglutide

Regulatory status: Approved in 2014 as weekly Eperzan (in Europe) and weekly Tanzeum (in the U.S.)
2013 sales: N/A
Peak estimate: Up to $800 million

Eli Lilly’s dulaglutide

Regulatory status: Under FDA review as a weekly agent
2013 sales: N/A
Peak estimate: Up to $2 billion

Intarcia’s once-a-year ITCA 650 (exenatide)

Regulatory status: In Phase III development with filing expected in 2016
2013 sales: N/A
Peak estimate: N/A

The former group, called GLP-1 therapies, are injectable treatments that work by bolstering the hormone glucagon-like peptide-1, which is naturally released after eating and regulates the body’s insulin secretion. The treatments bind to GLP-1 receptors and stimulate the release of glucose-dependent insulin while suppressing the release of glucagon, a hormone that raises blood sugar concentration.

While analysts expect the market for GLP-1 drugs to top out at around $5 billion a year, it’s been something of a slow trip upward since the first one, AstraZeneca’s ($AZN) Byetta, debuted in 2005.

”For whatever reason, primary care physicians have not exactly swarmed to the GLP-1 class,” Novo Nordisk ($NVO) Chief Medical Officer Alan Moses said. ”Part of that is just the inherent conservatism toward new therapies. And, in the U.S., it’s related to the fact that, considering an injectable versus an oral therapy, there’s still a perceived barrier there.”

In order to get exclusive rights to Byetta and Bydureon, its weekly counterpart, AstraZeneca signed a deal worth up $4.3 billion this year to take full control of its former diabetes alliance with Bristol-Myers Squibb ($BMY). But despite strong clinical results and a global marketing push, the two treatments brought in just $555 million combined in 2013.

Novo’s Victoza, a daily GLP-1 therapy approved in 2010, is the standard-bearer and sole commercial success among the class, bringing in $2 billion last year.

That figure makes it a big target for throne-watching rivals, including GlaxoSmithKline ($GSK), whose weekly albiglutide (recently approved as Tanzeum) tried and failed to demonstrate noninferiority to Victoza in its Phase III program.

Only one weekly agent has measured up: Lilly’s dulaglutide, a Phase III GLP-1 agonist that many consider the only significant threat to Novo’s leadership.

Lilly, starved for new products on a company-wide level, believes dulaglutide’s expected FDA approval and U.S. launch will give it a significant revenue-generator to dull the effects of some major patent losses. In the microcosm of diabetes, however, the drug’s impact will be even greater, Conterno said.

”We view dulaglutide as a catalyst for the whole GLP-1 class,” he said. ”Our thinking is we want for dulaglutide to become foundational to diabetes therapy.”

And Novo, while quick to point out that no GLP-1 entrant has topped Victoza on efficacy, believes a rising tide may raise all ships in the fledgling space.

”Dulaglutide’s comparability is good for the field,” Moses said. ”Lilly is a viable competitor, and I think together the two of us–with two good drugs–will have the potential of expanding the appreciation of the value of this class of drugs in Type 2 diabetes.”

Analyst projections for dulaglutide’s sales peak vary widely, with bulls expecting it to hit $2 billion with ease, while others worry that Victoza’s better marks in weight loss will keep Lilly’s drug from taking significant share.

From editors@fiercepharma.com

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