Mercks Januvia, Paired With Insulin, Improves Sugar Control
The findings are being presented today at the meeting of the American Diabetes Association in New Orleans. Amid a rise in obesity, 23.6 million people in the U.S. have diabetes, with about 90 percent suffering from the type-2 version, for which Januvia is approved as a treatment.
Growth of Mercks diabetes franchise helped offset slumping revenue of other products in 2008, the company said in a regulatory filing in February. The drugmaker, based in Whitehouse Station, New Jersey, is seeking approval from U.S. regulators to market Januvia, with $1.4 billion in 2008 global sales last year, for use with Actos. Merck also has applied for permission to sell Januvia and a related product, Janumet, for treatment along with insulin, said company spokeswoman Pam Eisele in an interview.
“Januvia is a big, important franchise,” said Cowen & Co. analyst Steve Scala in a telephone interview. “Right now its the only product of its type on the market. The product is growing well. Diabetes is a problem that is growing, so its important for Merck to keep it strong.” Scala said he owns Merck shares.
Multiple Drugs
As diabetes progresses, most of these patients need multiple drugs to manage their blood-sugar levels, said John Amatruda, senior vice president for diabetes and obesity products at Merck in a statement.
“We were very happy with the results,” Amatruda said in a telephone interview June 5. He added that his aim in modifying sugar control was to “get patients to the goal quickly, keep people at the goal and simplify therapy.”
“If approved for use with insulin, Januvia and Janumet will be additional options for patients with type 2 diabetes who are taking insulin and whose blood sugar is not at goal,” Amatruda said in the statement.
Januvia is a “tough competitor” and “well entrenched” in the diabetes-drug market, wrote Scala and other Cowen and Co. colleagues in a June 4 industry outlook note preceding the New Orleans meeting.
Cowens Scala said the company will face “serious” competition from the forthcoming diabetes drug Onglyza, known generically as saxagliptin from Bristol-Myers Squibb Co. and Astrazeneca Plc. The once-daily oral treatment is heading toward a U.S. regulatory decision on July 30, according to the Cowen report.
Mechanism of Action
Januvia, a once-daily tablet, was the first type-2 diabetes drug to improve the bodys ability to control blood sugar by inhibiting an enzyme called DPP-IV (dipeptidyl peptidase-4). Thats the same mechanism of action being targeted by Onglyza, according to Cowens report. Januvia is approved in 86 countries, Merck said.
In the first study of patients getting ongoing insulin treatment, 564 patients were also given Januvia or a placebo pill for 24 weeks. The Januvia-insulin combination reduced a measure of blood sugar control significantly compared with no change in the placebo group, the study said. Thirteen percent of patients taking Januvia and insulin together reached recommended blood-sugar levels, compared with 5 percent of patients who got the placebo with insulin, Merck said.
More Hypoglycemia
Patients who took Januvia had almost double the incidence of hypoglycemia or low blood sugar compared with people on insulin alone. Body weight didnt change in either group.
In the second study, 497 patients received Januvia plus Takedas Actos, also called pioglitazone, compared with Actos alone for 24 weeks. Patients who got the combination had an average 2.4 percent reduction in a measure of blood sugar control, compared with 1.5 percent reduction for patients on Actos alone.
Sixty percent of patients on the combination of Januvia and Actos reached recommended blood-sugar levels, compared with 28 percent of patients taking Actos alone, the study said.
Side effects including hypoglycemia, stomach upset and swelling were similar in the two groups, Merck said. People taking the Januvia combination gained more weight — an average of 6.6 pounds (3 kilograms), compared with 4.2 pounds (1.9 kilograms) on Actos alone.