New drugs vie for share of growing diabetes market (Reuters)

SAN DIEGO (Reuters) - Drug companies looking to fill sparse development pipelines are zeroing in on a fast growing market for diabetes treatments.

More than 18 million Americans now have the disease, and every year another 1.3 million are diagnosed as baby boomers age and a sedentary lifestyle continues to raise rates of obesity, the American Diabetes Association said at a weekend meeting.

It said direct medical costs for diabetes totaled $92 billion in 2002.

"We believe diabetes represents one of the most attractive, as yet unexploited sectors for healthcare investing over the next five years as a combination of new product stories combined with the fastest expansion of this disease fuels growth," WR Hambrecht analyst Andrew Forman said in a report last week.

In people with diabetes, either the body does not produce enough insulin, or their cells ignore the insulin, which is needed to turn food into energy.

Most cases are of the second type (type 2). Aging, obesity, physical inactivity and genetics among the causes. Less than a tenth of cases are of the first type (type 1), also known as juvenile diabetes.

Diabetes can lead to debilitating or fatal complications such as heart disease, blindness, kidney disease, and amputations.

Insulin has been a staple of treatment for decades, but many people with type 2 diabetes need only to have their body sensitized to the insulin they already produce.

Eli Lilly and Amylin Pharmaceuticals Inc. used the diabetes meeting to launch marketing efforts for Byetta, an injectable drug recently approved as adjunctive therapy to improve blood sugar control in patients with type 2 diabetes, whose blood sugar levels are not adequately controlled by common oral diabetes medications like metformin or a sulfonylurea.

Dr. Stuart Weiss, an endocrinologist at New York University Medical Center said his patients on Byetta were doing well.

Merck & Co. released encouraging early-stage trial data for an oral drug, MK-0431, which is designed to work in a way similar to Byetta.

In the mid-1990's a class of insulin sensitizing drugs known as glitizones was introduced. They include GlaxoSmithKline Avandia and Takeda Pharmaceutical Co.'s Actos.

Since then, a new class of compounds, called glitizars, have been developed that marry insulin sensitization with control of blood lipids -- fatty substances in the blood.

If approved by regulators, Pargluva, developed by Bristol-Myers Squibb and Merck, would be the first new drug in this class.

The two companies on Sunday presented pivotal-stage research showing that the drug, also known as muraglitazar, lowered blood glucose by 1.14 percent versus 0.85 percent for Actos.

It also lowered triglycerides by 28 percent versus 14 percent for Actos and raised good cholesterol by 19 percent, compared with 14 percent for Actos.

Side effects such as fluid retention and weight gain appeared to be slightly worse for Pargluva.

AztraZeneca Plc on Saturday showed data from an earlier-stage trial of its investigational glitazar, called Galida, showing that it also lowered fasting glucose levels, reduced triglycerides by 33 percent and raised good cholesterol by 15 percent.

Privately-held Metabolex Inc. presented data from a mid-stage trial of its drug, metaglidasen, which is designed to regulate the genes needed to improve insulin response without activating those that cause weight gain and swelling.

Final trial results showed that metaglidasen lowered blood sugar while limiting weight gain to 0.6 kg versus 1.3 kg for placebo.

Metabolex is looking to partner with a major pharmaceutical company to develop the drug.

The diabetes conference will also be the forum this week for the latest data on inhaled insulin. Companies including Pfizer Inc. have been trying to develop a safe form of the hormone that could be inhaled rather than injected.

"Variability of dose is a major issue. I kind of think that if inhaled insulin was going to happen, it would have happened by now," Weiss said.