New rivals to top diabetes drug Lantus show promise in studies

June 14 Sat Jun 14, 2014 1:00pm EDT

June 14 (Reuters) - Diabetes patients stand to benefit from two experimental insulin therapies that could eventually replace Sanofi's global leader Lantus, according to results from large clinical trials released on Saturday.

Sanofi's experimental new drug Toujeo is being positioned to succeed Lantus, whose annual sales approach $8 billion, when it loses patent protection early next year. Eli Lilly and Co is gearing up to sell a copycat version of Lantus, which industry analysts say could bring in up to $600 million a year by 2020.

Both treatments are basal insulins, which help diabetics keep blood sugar levels under control between meals and throughout the day.

Late-stage studies of Toujeo showed that patients with type 2 diabetes were 31 percent less likely at nighttime to have potentially dangerous declines in blood sugar than those taking Lantus, the world's most prescribed insulin, researchers said on Saturday.

Such episodes of hypoglycemia, in which patients can faint or lose consciousness, are the most feared side effect of insulins.

"Low blood sugar events, especially at night, are a big deal because they are frightening and are a barrier to use of insulin," Dr. Geremia Bolli, a professor at the University of Perugia, Italy, who helped lead one of the studies, said in a telephone interview. He presented his findings at the American Diabetes Association meeting in San Francisco.

More than 370 million people worldwide have diabetes, with up to 95 percent of them having type 2, a condition often triggered by obesity, according to the International Diabetes Federation. The disease raises the risk of numerous serious health problems.

Toujeo has the same active ingredient as Lantus, called insulin glargine, but in a three-fold higher concentration, Bolli said. Its activity level does not jump overnight, as is the case with Lantus.

The hypoglycemia data came from a combined review of three Phase III studies sponsored by Sanofi. The studies also showed that Toujeo and Lantus were similarly effective in controlling overall blood sugar and are the basis for Sanofi's recently filed U.S. marketing application for Toujeo.

The new drug is also awaiting approval in Europe.

In a fourth late-stage study involving patients with type 1 diabetes - the less common, inherited form of the disease - rates of hypoglycemia and overall blood sugar control were similar for Toujeo and Lantus.

LILLY'S LANTUS COPYCAT

While France's Sanofi develops the successor to its cash cow, a potential rival from U.S. drugmaker Eli Lilly proved just as effective and safe as Lantus for patients with type 1 and type 2 diabetes, including similar incidence of hypoglycemia.

Results for the Lilly drug, which has the same molecular formula as Lantus, were based on six studies sponsored by Lilly and its partner Boehringer Ingelheim.

"Completed clinical trials for this new insulin glargine product show that it works similarly in the body and produces clinical results similar to Lantus," said Dr. Tom Blevins of Texas Diabetes & Endocrinology in Austin, Texas, who helped lead the research.

Wall Street is expecting the copycat, called LY2963016, to be priced significantly lower than Lantus, in order to attract patients once Lantus loses patent protection.

Although awaiting approval in the United States, Europe and Japan, its U.S. launch could be delayed until mid-2016 by an ongoing patent dispute with Sanofi.

Lilly said the drug will not be designated a biosimilar, or biotech generic, in the United States, which does not yet have legislation regulating copycats of such drugs. Instead, it will be marketed as a branded medicine.

Lilly is also developing its own new basal insulin, called peglispro, which in clinical trial results released earlier this year, proved more effective than Lantus in reducing blood sugar levels for patients with type 2 diabetes. It also caused significantly fewer episodes of overnight hypoglycemia.

Lilly expects to seek U.S. and European approvals early next year for the drug. But patients taking peglispro had seriously elevated liver enzymes, a sign of potential liver toxicity, which could give Toujeo an advantage. (Aadditional reporting by Bill Berkrot in New York and Natalie Huet in Paris; Editing by Michele Gershberg, Bernard Orr)