FDA approves Amylin's diabetes drug

Prof Garth Cooper, CEO of Auckland biopharma company Protemix, said he was "extremely pleased" this week at the news that the US Food and Drug Administration has approved the clinical use of diabetes drug he discovered as a young PhD at Oxford in 1986-7.

Amylin Pharmaceuticals (NASDAQ:AMLN), the San Diego, California, company that Cooper founded in 1988, has announced that the FDA has approved Symlin (pramlintide acetate) as an injectable therapy to improve control of blood glucose levels in some diabetics.

Shares of Amylin rose more than 17 per cent to US$22.86 in after-hours trading

Amylin's President and CEO, Ginger Graham described the approval of SYMLIN - the therapy of its kind for diabetes - as "a major milestone" for the company.

Today Amylin is a US$4 billion company. Cooper returned to New Zealand from California in 1993 with the intention of building New Zealand's first million-dollar biopharma company.

Cooper said while he still takes a "huge interest" in Amylin he has had no role in the company since 1992. He retains a small shareholding, but said he had transferred the majority of his equity position to his new company. "I like to take my risk in what I'm doing now."

Symplin is a synthetic form of amylin, a molecule normally co-secreted from the pancreas with insulin; the two molecules work together to reduce elevated blood glucose levels after meals.

Chronic hyperglygaemia - abnormally high blood glucose levels - is associated with an increased risk of cardiovascular disease, including an enlarged heart, weight gain, and blindness.

In type 1 (insulin-dependent) diabetes, an auto-immune attack on the pancreas not only destroys its ability to secrete insulin, but amylin as well. In some type 1 diabetics, and type 2 diabetics who take insulin, insulin alone provides poor control over blood glucose levels - they suffer from abnormally high blood glucose after mealtimes.

A pre-mealtime injection of Symplin has been shown to give improved control over blood glucose levels, not only in the sub-group of type 1 diabetics who experience poor control, but in some type 2 diabetics who need insulin injections.

Amylin said its new drug would be available in 90 days. The company said is not for all diabetics: in those whose blood glucose is well controlled with insulin, its insulin-potentiating effect can result in hypoglycaemia - severe reduction in blood sugar levels.

Hypoglycaemia can occur within three hours of Symplin injection, and can impair cognitive function or even result in loss of consciousness.

During clinical trials, the drug was tested in 5300 diabetics. Adverse effects noted for Symplin, when co-administered with insulin, included gastrointestinal upsets and nausea. Gradually ramping up the dose from a low level reduced such effects, and patients adapted over time.

Symlin's US approval had been delayed by earlier questions from the FDA. Last year, Amylin withdrew its application to sell the drug in Switzerland after authorities there raised concerns about risks such as nausea and hypoglycemia.

Laszarin in trials

Cooper's new Auckland-based company, Protemix has another promising drug for a life-threatening complication of diabetes, Laszarin, in Phase IIb clinical trials in the Melbourne; a similar trial will begin soon in Brisbane.

Protemix is planning to begin a phase III trial in the second half of next year, and Cooper said it will probably look for a Big Pharma company after the trial begins - "We think the drug is going to be such a large project that we'll need to partner for marketing purposes, but we're going to retain some marketing rights for ourselves."