tony, I wouldn't get too excited about the results. There is clearly room for improvement and the delay (wait for studies on sub-groups) could be intrepreted VERY negatively by the market. The San Diego Union sometimes goes out of its way to avoid positive spins. Here's what they said yeaterday:
Amylin diabetes drug shows mixed results in testing |
Afflicted juveniles fared better than adults over time
Thomas Kupper
STAFF WRITER
16-Aug-1997 Saturday
Amylin Pharmaceuticals reported mixed results yesterday in late-stage
trials of its diabetes drug, but the San Diego company said it remains
optimistic about further tests.
The drug, pramlintide, lowered blood sugar levels in adult-onset diabetics
over six months but did not show significant benefit over a 12-month
period, the company said.
However, the results were more encouraging in a study of juvenile-onset
diabetics. Those patients showed reductions in blood sugar levels and
improved weight and cholesterol profiles.
"In our view, the results of these initial phase III studies are consistent
with the growing body of preclinical and clinical data for amylin
replacement therapy," said Dr. Maurizio Denaro, Amylin's chief technical
officer.
Amylin's drug is designed to replace a key hormone, amylin, that the
company believes plays a crucial role in glucose control. The company has
planned four more trials, two each in juvenile-onset and adult-onset
diabetics.
Amylin shares dropped 37 1/2 cents yesterday to close at $14.87 1/2 before
the announcement.
James McCamant, editor of the Medical Technology Stock Letter in Berkeley,
said the results appeared encouraging, despite the lack of long-term
effects in adult-onset patients.
"All in all, I would have to say that this is positive," McCamant said. "In
drug development, it's almost never a completely smooth road."
Amylin said the results in adult-onset patients may have been hampered by
large numbers of patients who varied their doses of insulin, which patients
take along with pramlintide.
However, the company said it has designed the remaining trials differently
to try to control patients' insulin doses better. The company believes this
may bring better results.
Diabetes, afflicting 140 million people worldwide, is a potentially huge
market. Amylin hopes to complete the four other trials in mid-1998 and
apply for regulatory approval by the end of 1998.
The study, co-sponsored by Johnson & Johnson, was aimed at proving that
amylin replacement therapy in insulin-using diabetics can help them control
their metabolism without common side effects of insulin therapy alone, such
as weight gain and sudden dips in blood sugar.
In juvenile-onset diabetics, the drug improved glucose control, weight
control and cholesterol levels without increasing the risk of hypoglycemia
-- or drops in blood sugar levels, Amylin said.
Both groups of patients showed occasional nausea, particularly at the
beginning of the trial. In the juvenile-onset patients, 45 percent reported
nausea, though Amylin said the symptoms were generally mild. |
