Takeda heartburn drug beats Prevacid in studies

Takeda Pharmaceutical Co Ltd’s experimental heartburn drug has proven more effective in healing inflammation of the esophagus than Prevacid, a blockbuster older drug sold by the Japanese drugmaker, researchers said on Sunday.

Favorable results for the new medicine TAK-390MR, which is an altered form of Prevacid, came from two late-stage trials whose results were described at the annual meeting in San Diego of Digestive Disease Week.

It was tested among patients with erosive esophagitis, a potentially dangerous inflammation or ulceration of the esophagus caused by backflow of acid from the stomach.

The main goal of the two trials, which together involved 4,092 patients with the condition, was to assess healing of the esophagus after eight weeks of treatment.

Patients received either 60-milligram or 90-milligram daily doses of TAK-390MR, or daily 30 milligram doses of Prevacid—an almost $2 billion-a-year drug whose sales are expected to plunge when it faces generic competition in November 2009.

Takeda is hoping to introduce TAK-390MR late this year, and begin switching Prevacid patients to it before the older drug faces the generic onslaught.

In both studies, the benefit of the 90 milligram dose of TAK-390MR was statistically superior to Prevacid. Although the lower dose of the experimental drug produced numerical improvement, the degree of healing did not reach statistical significance.

By one measure called life table analysis, 93 percent of patients taking the 60 milligram dose of TAK-390MR in one trial achieved healing, as did 95 percent of patients taking the higher dose. That compared with healing among 92 percent of patients taking Prevacid.

By another measure called crude rate analysis, 87 percent of patients taking 60 milligram TAK-390MR in the same trial and 89 percent of the 90 milligram group experienced healing, versus 85 percent of those receiving Prevacid.

Results were more persuasive in the second trial, where both of the TAK-390MR dosage groups achieved at least a 6 percentage-point improvement over those receiving Prevacid, by both study measures.

Merrill Lynch analyst Masatake Miyoshi on April 24 said results of the two trials, as described in a brief preview summary, were “moderately satisfactory.”

But he cautioned that data from the esophagus trial alone might not be a major selling point because AstraZeneca Plc’s popular Nexium heartburn drug has achieved similar protective results in its own clinical trials.