MORRISVILLE – Circassia Pharmaceuticals, a British company with U.S. headquarters in Morrisville, has commercially launched Duaklir, a maintenance treatment for patients with chronic obstructive pulmonary disease (COPD), in the United States.

Duaklir will be promoted through Circassia’s COPD sales force, which also markets Tudorza, another COPD treatment. Both therapies are administered twice daily through Pressair, the company’s pre-loaded, breath-actuated, multi-dose inhaler.


“Today’s launch of Duaklir is the culmination of a strategic and concerted effort to help improve the lives of millions of Americans living with COPD,” said David Acheson, Circassia’s senior vice president, U.S. commercial. “We are proud of the team at Circassia for working to achieve this important milestone, and are grateful to the researchers and patients for their contributions in helping to bring this important new COPD therapy to the U.S. market.”

COPD is a progressive disease associated mainly with tobacco smoking, air pollution or occupational exposure that makes breathing difficult. It is the third leading cause of death due to disease in the United States, according to the American Lung Association, and the number of people dying from COPD is growing. More than 11 million people have been diagnosed with COPD, but millions more may have the disease without knowing it.

Duaklir Pressair is a fixed-dose combination of the long-acting muscarinic antagonist (LAMA) aclidinium and the long-acting beta agonist (LABA) formoterol. The product is approved worldwide, including in the European Union, under various brand names.

The U.S. Food and Drug Administration’s approval of Duaklir in March was based on data from three Phase 3 studies and one Phase 4 study.

Results from one of the Phase 3 trials, called Amplify, showed that the combination LAMA/LABA therapy was more efficacious than its individual components, with a comparable safety profile, said Sanjay Sethi, M.D., professor and chief of pulmonary, critical care and sleep medicine at the University of Buffalo’s Jacobs School of Medicine & Biomedical Sciences, and an investigator on the Amplify trial.

“Duaklir Pressair will be a welcome addition to the armamentarium to help these patients,” Sethi said.

Circassia acquired the U.S. commercial rights to Tudorza (aclidinium) and Duaklir from AstraZeneca, a multinational pharmaceutical company based in Cambridge, England.

Circassia is part of the Circassia Pharmaceuticals plc group, a global specialty pharmaceutical business focused on respiratory disease.

The company sells its Niox asthma-management products directly to specialists in the United States, United Kingdom, China, Germany and Italy, and in other countries through its network of partners.  Circassia also has the U.S. and Chinese commercial rights to the late-stage ventilator-compatible nitric oxide product LungFit PH.

Circassia was established in 2006 and has global headquarters in Oxford, England. In 2014 it completed an initial public offering of stock on the London Stock Exchange.

The company moved its U.S. headquarters from New Jersey to Morrisville in 2012. The Morrisville site employs about 50 people in management, customer service, accounting, marketing, training and other administration.

(C) N.C. Biotech Center