CALIFORNIA : Amylin Claims Success for Diabetes Drug
Amylin Pharmaceuticals said Tuesday that its top drug prospect, Symlin, has been able to improve blood sugar control and promote weight loss in patients with adult-onset diabetes.
The statistically significant results could signal a reversal of fortune for the once-highflying San Diego biotechnology company, which in the last year has cut 85% of its staff after earlier trials of the injectable drug proved disappointing.
Following release of the latest findings, Amylin’s share price more than doubled before settling down to close at $3.91, up 56%, on Nasdaq.
In a yearlong study that included 656 patients with Type 2 diabetes, those taking Symlin twice a day in addition to insulin showed significantly lower levels of blood sugar and lost an average of 3.1 pounds. Patients who did not take the experimental drug had a much smaller reduction in blood sugar and actually gained weight.
“It is very welcome news for Amylin and very welcome news for the 3.3 million patients [in North America and Europe] with Type 2 diabetes who are currently at the stage of diabetes where they require multiple insulin injections each day,” said Amylin Chairman and Chief Executive Joseph C. Cook Jr.
The company expects to complete a similar trial later this year in patients with Type 1 or juvenile-onset diabetes. When the results of that study are complete, the company intends to seek Food and Drug Administration approval to begin marketing the drug.
“We are right on schedule,” said Cook, who acknowledged that the firm’s fortunes are still very dependent on review by federal regulators.
Symlin, or pramlintide, is a synthetic version of a naturally occurring hormone that appears to work with insulin to control blood sugar. Preliminary studies of the drug were encouraging and in 1995 pharmaceutical giant Johnson & Johnson agreed to share the cost of development and marketing. But then came the inconclusive clinical trials and a decision by Johnson & Johnson to pull out of the partnership.
Shares of Amylin stock, once at $20, plunged to less than a $1. The company retrenched and redesigned its trials, a move that led to the latest positive results.
Hambrecht & Quist biotech analyst Meg Malloy said she found the results “encouraging,” but noted: “There’s still a fair amount of risk. We don’t know what the FDA will require.”
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Drug Benefits
After a series of setbacks in its drug developments and a drop in share price, Amylin Pharmaceuticals was moved from the Nasdaq National Market to the Nasdaq SmallCap Market. But on Tuesday, its stock zoomed 56% on news that an experimental drug for diabetics shows promise. Weekly closes and latest:
Tuesday: $3.91
Source: Bridge Information Systems
