Eli Lilly & Co. (LLY:US) is betting on a “broad” range of diabetes products including pills, insulins and a once-a-week treatment to take on bigger competitors, said Enrique Conterno, president of Lilly Diabetes.
Lilly is working on two experimental long-acting insulins, including a version of Sanofi’s top-selling Lantus, and therapies in all the main new classes of diabetes drugs, such as a GLP-1 agonist and an SGLT2 inhibitor.
“No one that I am aware about has this kind of pipeline,” Conterno said in an interview in Berlin, where he was attending the European Association for the Study of Diabetes conference. “Some companies are much more focused on one or two classes, some are more focused on one product. This will provide us a competitive advantage. We like where we stand.”
Diabetes afflicted 366 million people worldwide last year, according to the International Diabetes Federation. Drugmakers are developing new products as the market is likely to grow to more than $58 billion in 2018 from $35 billion now, Standard & Poor’s said in an Oct. 4 report. Eli Lilly, the maker of the Humalog and Humulin insulins, lost ground in past years to Denmark’s Novo Nordisk A/S (NOVOB), the world’s biggest insulin maker, and Sanofi (SAN), whose Lantus garnered 3.92 billion euros ($5.1 billion) in sales in 2011.
Eli Lilly, based in Indianapolis, reorganized its diabetes operations almost three years ago, Conterno said. Last year, the company ended a decade-long diabetes partnership with Amylin Pharmaceuticals Inc., the maker of Byetta and Bydureon. This allowed Lilly to focus on its own diabetes pipeline. Many products are developed with Germany’s Boehringer Ingelheim GmbH as part of a deal struck in 2011 to work on diabetes drugs.
In June, Lilly presented mid-stage trial results for a new long-acting insulin, dubbed LY2605541. The therapy would directly compete with Lantus and Novo’s Tresiba, which is currently being reviewed by the U.S. Food and Drug Administration.
LY2605541 matched Lantus in blood-sugar control while helping patients lose weight, unlike all other insulins, the data showed. However, patients taking the Lilly product had an increase in liver enzymes, a potential sign of liver damage, compared with those taking Lantus, the trial results showed.
Lilly also published promising results on the SGLT2 inhibitor empagliflozin and its once-a-week experimental GLP-1 agonist, known as dulaglutide.
People suffering from diabetes lack the insulin needed to convert blood sugar into energy. GLP-1 agonists such as dulaglutide mimic the function of a digestive hormone that stimulates the pancreas to produce insulin after meals.
SGLT2 inhibitors reduce glucose reabsorption in the kidney, leading to excretion of excess glucose via the urine.
“Looks like we’ve made good progress,” Peruvian-born Conterno said last week. “Our competitors are talking a lot more about us, and that’s a very good sign.”
The decision to end the Amylin partnership wasn’t easy, Conterno said.
The move was, “in essence, a bet on dulaglutide,” he said. “We’ve gotten more and more data and the product so far looks very, very good. We like what our prospects are.”
Dulaglutide, if approved, would compete with Byetta and Bydureon, which Eli Lilly is still selling outside the U.S., according to Conterno.
Bristol-Myers Squibb Co. (BMY:US), which acquired Amylin for $5.3 billion earlier this year, and partner AstraZeneca Plc will soon take over the products, he said.
Lilly will ensure the transition for Byetta and Bydureon is made “in the best way,” Conterno said.
Eli Lilly’s competitors are starting to take notice. “Lilly really seriously wants to be back in the innovation- driven space,” Mads Krogsgaard Thomsen, Novo Nordisk’s chief scientific officer, said in an interview last week in Berlin. “My eyes are clearly on what Lilly is doing because they are the ones that have a pipeline in our area of R&D, unlike others.”
Some aspects of Lilly’s diabetes strategy still raise questions.
The company is developing its new basal, or long-acting, LY2605541 alongside a biosimilar version of Lantus, also a long- acting insulin. If both were approved, the products would compete with each other.
It’s still unclear “how Lilly wants to prioritize its biosimilar version of Lantus,” Alistair Campbell, an analyst at Berenberg Bank, said in a telephone interview. If late-stage results from LY2605541 are good, “they will pretty much prioritize that, but if that drug falls on the way, then I would expect them to prioritize the biosimilar much more.”
Eli Lilly plans to move ahead with both projects, Conterno said. The Lilly version of Lantus would be introduced as soon as Sanofi loses the patent on the product in 2015, he said.
“Assuming both complete trials successfully, we intend to launch both,” Conterno said. “Clearly the innovative basal insulin can be a game changer.”
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