Aug. 28 (Bloomberg) -- Nycomed A/S’s Daxas pill improves lung function and reduces flareups in patients suffering from smoker’s cough, according to two articles in The Lancet.

Daxas, a once-a-day anti-inflammatory agent, may become an important treatment for patients with chronic obstructive pulmonary disease, or smoker’s cough, who have respiratory symptoms and are at greater risk of exacerbations, according to the articles, which reported results of four trials. The benefits persist when the drug is added to the standard treatment of long-acting, inhaled medicines that open bronchial pathways, researchers said.

The findings may help Zurich-based Nycomed win regulatory approval for Daxas, known chemically as roflumilast, four years after regulators rejected the treatment because they said more evidence was needed that it worked. Daxas has the potential to generate $1 billion in peak annual sales, Nycomed Chief Executive Officer Hakan Bjoerklund said in an Aug. 10 interview.

“Roflumilast improves lung function in patients with COPD whether or not they’re treated with long-acting bronchodilators,” said one of the authors, Leonardo Fabbri from the University of Modena and Reggio Emilia, Italy, in a presentation in London yesterday.

Chronic obstructive pulmonary disease is caused by cigarette smoke and other fumes that obstruct the flow of air into the lungs. The condition affects 210 million people worldwide, according to the World Health Organization. More than 3 million people died from it in 2005. Total deaths are projected to increase more than 30 percent in 10 years without interventions to cut risks, according to the WHO.

U.S. Rights

Nycomed, controlled by Nordic Capital and a buyout unit of Credit Suisse Group AG, this month sold U.S. rights to Daxas to New York-based Forest Laboratories Inc.

Daxas proved beneficial regardless of the patient’s smoking status and use of other medications, according to results from the first two trials. The rate of exacerbations that were moderate or severe per patient per year was 17 percent lower in the people treated with Daxas compared with those given placebo, the results showed. Adverse side effects also were more common in patients treated with the drug, they showed.

Results from two other trials showed that Daxas further improved lung function in patients already receiving GlaxoSmithKline Plc’s Advair and Boehringer Ingelheim GmbH’s Spiriva, inhaled drugs in a class known as bronchodilators. It also improved respiratory symptoms, but was associated with more adverse events including nausea, diarrhea and weight loss.

The side effects “are not extremely worrying,” said Klaus Rabe, a researcher at Leiden University Medical Center in the Netherlands, who wrote the second article.

New Treatment

Daxas, which is a phosphodiesterase 4 inhibitor, would be a new class of treatment for COPD if it is approved, Rabe and Fabbri said. “In terms of novelty, this is going to be the only new drug in the next, at minimum, five years,” Fabbri said. However, it won’t replace bronchodilators, he said. “It will definitely be used on top of existing medications,” he said.

Nycomed acquired Daxas when it bought Altana AG’s pharmaceutical unit in 2006. Nycomed sought U.S. approval to market Daxas last month and submitted the medicine for European Union regulatory review in May.

Nycomed, which had sales of 3.35 billion euros ($4.78 billion) last year, needs Daxas to replace sales lost when its top seller, the Pantoprozole heartburn medicine, loses patent protection. Pantoprozole goes off-patent in Europe this year and in the U.S. next year.

To contact the reporter on this story: Albertina Torsoli in Paris at atorsoli@bloomberg.net; Andrea Gerlin in London at agerlin@bloomberg.net.

Last Updated: August 27, 2009 18:37 EDT