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By Michelle Fay Cortez

Oct. 23 (Bloomberg) -- Novo Nordisk A/S’s diabetes drug liraglutide helped obese, healthy volunteers lose significantly more weight and cut their blood pressure more than Roche Holding AG’s obesity treatment Xenical, a study found.

The study involving 564 people found just five months of liraglutide injections shaved 4.8 kilograms (10.6 pounds) to 7.2 kilograms from their frames, compared with 4.1 kilograms for those on Xenical and 2.8 kilograms for those given placebo.

The research suggests that liraglutide may be more effective than currently available treatments for obesity. About half of Europeans and two-thirds of Americans are overweight, and 30 percent are considered obese, studies show. Few treatments are available. Novo Nordisk, based in Bagsvaerd, Denmark, funded the research that appears in the journal Lancet and has another trial under way.

“Overall, the results of this study indicate the potential benefit of liraglutide, in conjunction with an energy-deficit diet, in the treatment of obesity and associated risk factors,” said the researchers, led by Arne Astrup, from the University of Copenhagen’s department of human nutrition. “Liraglutide offers a new mode of action for the treatment of obesity and improved efficacy compared with currently available therapies.”

Tracked Patients

The researchers tracked the patients for two years, and found those on liraglutide kept the weight off, Novo Nordisk’s Chief Scientific Officer Mads Krogsgaard Thomsen said in a telephone interview. More research is needed to confirm the benefits and answer additional questions, including what happens when patients stop taking the injected medication, he said.

The research is the second of three phases of trials generally needed to win regulatory approval. Novo Nordisk said it is waiting to hear from U.S. regulators this quarter about the use of the drug for diabetes before it starts additional large weight loss trials. Liraglutide is approved for diabetics in Europe, where it’s marketed under the name Victoza.

Blood pressure levels dropped in all patients taking liraglutide, while signs of impending diabetes, marked by slightly elevated blood sugar levels, fell by as much as 96 percent, the study found.

“Liraglutide improved several factors associated with cardiovascular events over 20 weeks, which are regarded as more clinically relevant than weight loss per se,” the researchers said. “The long-term risk-benefit profile for liraglutide, as well as its weight maintenance capabilities, remain to be established.”

Side Effects

The most common side effects were nausea and vomiting, which generally occurred within the first month. There were no signs of other serious side effects, including pancreatitis, psychiatric complications or thyroid cancer. Obese patients got a twofold greater dose of the drug than diabetics, Thomsen said. Participants in the study also followed a calorie-restricted diet and increased their physical activity.

The rising rates of obesity during the past two decades have coincided with a dramatic increase in diabetes, leading many public health officials to declare that epidemics are under way with both conditions.

Healthy patients in Astrup’s study lost more weight than diabetics in earlier studies who were taking the same doses of the drug, said George Bray, from Louisiana State University’s division of clinical obesity and metabolism in Baton Rouge, in an editorial. It may be that people without diabetes are more responsive to the drug, which stimulates insulin production, slows the emptying of the stomach, and decreases food intake, he said.

GLP-1

Liraglutide belongs to a class of drugs that imitate a hormone called GLP-1, stimulating the pancreas to produce more insulin after meals.

“Whether long-term use of an injectable drug is palatable as a treatment for obesity is yet to be established,” Bray wrote. “From what we do know about GLP-1 agonists and their mechanisms, we can be optimistic that their promise for the treatment of obesity will be fulfilled.”

Efforts to develop obesity drugs have suffered setbacks. Sanofi-Aventis SA pulled Acomplia off European shelves last year after regulators recommended suspension of sales. The medicine failed to win the backing of a U.S. advisory panel in 2007 after it was linked to suicide.

Merck & Co. last year stopped development of taranabant, in the same class of medicine as Acomplia, because it made people depressed and irritable. Pfizer Inc., the world’s biggest drugmaker, also ended early-stage work on obesity treatments as part of a research overhaul last year.

GlaxoSmithKline Plc sells a form of Xenical, known chemically as orlistat, in a lower-dose, over-the-counter formulation known as Alli.

-- Editors: Phil Serafino, Kristen Hallam The company said it will add around 100 positions worldwide, though mainly in countries of the European Union, to speed up the launch and commercialization of ceftobiprole, a broad-spectrum antibiotics, and alitretinoin, a treatment for hand eczema.

At its Swiss headquarters, Basilea plans to create 17 positions.

Meanwhile, it will reduce some jobs in the U.S. and around 30 jobs at its headquarters focusing on lower-priority research.

Ceftobiprole is marketed as Zeftera in Canada and Zevtera in Switzerland. In November, the drug was recommended for approval by the E.U. advisory committee for severe skin and soft tissue infections.

The headcount reduction in the U.S. is due to a delay in the approval procedure for ceftbiprole. Last fall, the U.S. market regulator FDA issued a so- called Complete Response Letter to Johnson & Johnson Co. (JNJ), Basilea's U.S. partner, requesting additional information on the nature of data gathering in the U.S.

Basilea now expects to receive word from the FDA in the second quarter of 2009 concerning ceftobiprole, a company spokesman said.

Originally, U.S. approval of the drug had been expected for the first quarter of 2009.

E.U. approval is expected in the first quarter of this year, the spokesman said.

Alitretinoin is already marketed in Denmark, Germany and the U.K. under the name of Toctino.

Basilea named Laurenz Kellenberger as chief scientific officer and a member of the executive committee. He will replace Jutta Heim who is leaving the company.

Company Web site: www.basilea.com

-By Martin Gelnar, Dow Jones Newswires, +41 43 443 8042; martin.gelnar@ dowjones.com

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