The dust has settled in the boardroom battle for control over Amylin Pharmaceuticals, and now it’s time to get back to fundamentals. The San Diego-based biotech company hopes to grab the attention of physicians and investors this weekend with some new clinical trial data that suggests its once-weekly shot for diabetes was able to maintain control over blood sugar for two years, while helping patients lose weight and lower their blood pressure.
The findings were from a study of 295 patients, who got exenatide once weekly, according to researchers who participated in a three-way collaboration of Amylin, Indianapolis-based Eli Lilly, and Cambridge, MA-based Alkermes. Data from the study called Duration 1 was presented today at the American Diabetes Association‘s annual meeting in New Orleans.
Amylin has been under fire since August, when the FDA warned physicians that there were several cases of patients who developed pancreatitis while taking its best-selling drug, exenatide (Byetta). Two of the patients died. Demand for the drug has fallen since then, and Amylin’s stock lost two-thirds of its value in the past year, creating an opening for dissident shareholders to win two of the 12 seats that were up for election to the company’s board last month. The top strategic priority of the company is now on winning approval of the new version of exenatide, which can be injected just once a week, instead of the current treatment that must be injected twice a day. Diabetes affects an estimated 23 million people in the U.S. If FDA-approved, the once-weekly drug could generate $1.35 billion in U.S. sales in 2013, according to JP Morgan analyst Cory Kasimov, in a note to clients.
“For a single injection given once a week, the data are remarkable,” said Ken Wilhelm, Amylin’s senior director of medical affairs.
The study was designed to randomly assign patients to get the usual exenatide twice a day, or once-weekly exenatide, for a little more than six months (30 weeks). Once that comparison was complete, all patients could switch over to get the once-weekly version for a total of two years.
Almost two-thirds of patients reached the goal of bringing their blood sugar down to a medically acceptable level. Patients on the once-weekly drug were able to bring their hemoglobin A1C scores down by 1.9 percentage points from when they entered the study, a little better than the 1.5 percentage point drop seen among patients on the standard exenatide, Wilhelm says.
Nausea was the most common side effect during the 30-week comparison period. About one-fourth of patients (27 percent) reported at least one bout of nausea in the initial period, although that decreased the longer patients stayed on the drug, falling to 12 percent in the final 74-week stretch when all patients were getting the once-weekly version. No severe cases of low blood sugar, or hypoglycemia, were seen.
Separately, Amylin looked into the rate of pancreatitis among patients taking its product, which caused so many headaches for the company last fall. The events are too rare to show up in a company-sponsored clinical trial, Wilhelm says. Pancreatitis tends to show up in greater number in diabetic patients than in the general population, but based on looking back at patient records in managed care databases, Wilhelm says it didn’t see any elevated risk for pancreatitis among diabetic patients taking exenatide.
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