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Pharmaceuticals
Diabetes Duel
Matthew Herper, 06.13.06, 9:00 AM ET




New York -

Merck and Novartis unveiled new data on two rival diabetes pills that are as effective as existing treatments but without side effects like low blood sugar and weight gain.

The pills, dubbed Januvia and Galvus, are expected to reach the U.S. market in less than a year and could bring in combined sales of $5 billion by 2010, according to industry analysts. But neither company has yet eked out a clear advantage in what could be a spirited marketing battle.

Diabetes afflicts some 21 million Americans, putting them at increased risk of heart attacks, kidney disease and blindness. In the most common form, a poor diet and lack of exercise lead the body to stop responding to the hormone insulin, which tells cells to take sugar from the blood. This causes levels of blood sugar to rise, damaging the internal organs. In order to treat diabetes, doctors prescribe medicines that prevent excess sugar from building up in the blood, or spur the body to produce more insulin.

Januvia and Galvus appear not only to spare patients the side effects of older medicines, but also to help preserve the beta cells in the pancreas--the cells that produce insulin, and that often die off in diabetes patients. Both pills work by inhibiting an enzyme called dipeptidyl peptidase 4 (DPP-IV), which breaks down hormones that help control blood sugar.

"It's going to be a nice addition," says James Underberg, a New York University lipidologist who participated in the Januvia trials. He says he sees doctors using the medicine early on, before the beta cells have started to deteriorate. "The sooner you use a drug like this, the more beta cell function you're going to spare."

In a year-long, 800-patient trial presented today, Januvia controlled blood sugar levels as well as glipizide, a commonly used diabetes drug sold by Bristol-Myers Squibb (nyse: BMY - news - people ) under the name Glucotrol. Patients on Januvia experienced slight weight loss, while those on Glucovance gained an average of 2.4 pounds. Moreover, while 32% of patients on Glucovance had an episode of low blood sugar, only 5% of those on Januvia did. Overall, the side effects of Januvia were similar to those of a sugar pill. Merck (nyse: MRK - news - people ) will host a conference call today to review the clinical data surrounding Januvia.

The results for Galvus were similarly impressive. A combination of Galvus and Actos, a diabetes medicine made by Takeda Pharmaceutical, allowed two-thirds of patients in one big trial to adequately control their diabetes; taken alone, both drugs helped about 43% of patients reach that goal. A comparative trial with Avandia, from GlaxoSmithKline (nyse: GSK - news - people ) showed that the two were equally effective at lowering blood sugar, but severely obese patients in the study who took Galvus actually lost weight. Novartis (nyse: NVS - news - people ) announced that it would be doing a series of "mega trials," dubbed "GLORIUS," to prove the benefits of the drug.

As of yet, there seems to be little difference between the two drugs. Many analysts expect the two drug makers to eventually try to replace medicines like Glucovance as first-line treatments against diabetes.

For the time being, most industry watchers handicap Merck as having a slight advantage.

Januvia was accepted by the U.S. Food and Drug Administration three months earlier than Galvus (an FDA decision on Januvia is expected by October). Moreover, while both drugs are being promoted as once-a-day treatments, analysts think Januvia may better fill that claim.

"[Galvus] can be once a day, but in order to be competitive with Januvia in efficacy it's twice a day," says Barbara Ryan, an analyst at Deutsche Bank (nyse: DB - news - people ). "They're both good drugs."

Byetta, the successful diabetes injection from Eli Lilly (nyse: LLY - news - people ) and Amylin (nasdaq: AMLN - news - people ), is a synthetic version of one of these hormones. That drug can also cause weight loss, but is only available as a shot and can cause nausea.




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Companies: MRK | NVS | BMY | MRK | GSK

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