Major pharmaceutical companies are fighting harder over the millions of patients with diabetes, a lucrative area because the pool of customers keeps growing with the obesity epidemic — and they will need daily drugs or insulin for life.
As the American Diabetes Association conference opened Friday, companies began presenting research on experimental drugs, including a few in a new class, and data on existing drugs for which they hope to capture many more customers.
Meanwhile, Boehringer Ingelheim Pharmaceuticals Inc. has jumped into the diabetes field and will be reporting on two experimental drugs and its diabetes pipeline.
"Why wouldn't you get in?" said Miller Tabak analyst Les Funtleyder. "It's a big market, it's a chronic market and there's unmet need."
230 million people have diabetes
More than 230 million people worldwide are estimated to have diabetes — nearly an eightfold jump since 1985 — and nearly 4 million died of the blood sugar disorder in 2007, according to the World Diabetes Foundation. Up to half of patients can't keep their blood sugar levels at their goal with their current medicines, diet and exercise. That increases risk of complications including blindness, amputations and kidney damage.
Those patients are targets for drugmakers hoping their new products will muscle aside older drugs, or at least be added to ones patients already are taking. Global sales of diabetes drugs totaled $27.3 billion last year, making them the No. 4 class, according to IMS Health.
"We need innovation in detecting and monitoring diabetes, in therapeutic effectiveness and in convenience of administering treatment," said Erik Gordon, an analyst and professor at the University of Michigan's Ross School of Business.
Among expected conference highlights, according to analysts:
- Data on a a new "smart" insulin pump from Medtronic Inc. that continually monitors blood sugar to prevent dangerously low levels as well as spikes.
- New reports on an experimental, long-acting version of Byetta, sold by Eli Lilly and Co. and Amylin Pharmaceuticals Inc., which improves blood glucose control by signaling the pancreas to make the right amount of insulin after a meal and reducing appetite — and often weight, too. It is an injected twice a day; the new version, if approved, would be once a week.
Edward Jones Senior healthcare analyst Linda Bannister will be watching for safety data on it, because some earlier research on drugs in its class, the GLP-1 stimulators, indicated possible risk of thyroid cancer and inflammation of the pancreas, the organ that makes insulin.
It "has the potential to be a strong competitor if the risks are manageable," Bannister said, adding long-acting Byetta offers patients long-term blood sugar reduction and "most importantly for some, weight loss." That's key because many diabetes drugs cause weight gain.
The drug should be launched next year if approved, boosting total Byetta sales from $430 million last year to $2.2 billion in 2013, Cowen & Co. analysts forecast.
Novo Nordisk Inc. will present late-stage data on blood sugar and weight control with its GLP-1 drug, once-a-day liraglutide. And Britain's GlaxoSmithKline PLC has mid-stage data on its GLP-1, albiglutide, given as infrequently as once a month.
- Glaxo also will present data on rates of hospitalization and death from cardiovascular problems in patients taking its Avandia, versus two other drugs. Avandia sales dropped after a 2007 journal report suggested it can raise chances of heart attack and cardiac death.
- Bristol-Myers Squibb Co. and Boehringer Ingelheim are reporting on experimental SGLT-2 inhibitors, which appear to block the kidneys from reabsorbing glucose — and perhaps prevent kidney damage. Some diabetes specialists say more data on risks and benefits is needed.
Bristol-Myers is presenting mid-stage data on dapagliflozin, taken with insulin and widely used diabetes pills.
Boehringer Ingelheim has laboratory data on its two SGLT-2 drugs, as well as results of midstage human testing of its lead diabetes compound, DPP-4 inhibitor linagliptin.
When blood sugar is high, DPP-4 inhibitors boost insulin production and reduce glucose production in the liver. They became the first new class of diabetes pills in nearly a decade when Merck & Co. launched Januvia late in 2006.
- Merck will try to boost use with studies on how well Januvia works along with insulin, generic metformin and another drug. But Pfizer Inc. and partners Bristol-Myers and AstraZeneca LP are presenting data on their experimental DPP-4 inhibitors, which could become Januvia competitors.
