MORRISVILLE -=Circassia Pharmaceuticals, a British company with U.S. headquarters in Morrisville, plans to acquire the full U.S. commercial rights to Tudorza, a treatment for chronic obstructive pulmonary disease (COPD) from British drug-maker AstraZeneca by the end of this month.

Circassia, a specialty pharmaceutical company focused on respiratory disease, has been promoting the COPD treatment in the United States under a profit-share arrangement established by the two companies in April 2017.

“Exercising our option for the full U.S. commercial rights to Tudorza represents a strategic opportunity for Circassia,” said Steve Harris, the company’s chief executive officer. “We will have significantly more control of the product’s commercialization strategy, and with prescription levels continuing to stabilize, we now have a robust foundation from which to grow the product.”

Circassia is amassing a sales force and support staff of 150 employees dedicated to its COPD products and is now hiring 71 sales professionals toward that total, said David Acheson, Circassia’s senior vice president and general manager of U.S. operations.

David Acheson Circassia Photo

He said the expanded staff would prepare for Circassia’s acquisition of full marketing rights to Tudorza and to Duaklir, another COPD therapy from AstraZeneca that is currently under FDA review with a target completion date of March 31, 2019.

“The launch of a dedicated sales force to support Circassia’s COPD franchise in 2019 is extremely exciting for our U.S. operations,” Acheson said. “As a leader in respiratory care, it is gratifying to be able to advance the care of people living with this serious and deadly illness.”

COPD is a group of progressive lung diseases including emphysema, chronic bronchitis and refractory (non-reversible) asthma. Characterized by increasing breathlessness, COPD currently has no cure but can be managed with various therapies.

More than 11 million Americans have been diagnosed with COPD, and many more suffer from undiagnosed cases. COPD is the third leading cause of death, behind heart disease and cancer. Smoking tobacco us the greatest cause of the disease.

Terms of the Deal

Under the terms of Circassia’s agreement with AstraZeneca, completion of the option exercise for Tudorza will trigger a payment of $5 million. A deferred Tudorza option payment of $20 million will be payable upon approval of Duaklir, in addition to deferred consideration of $100 million.

Tudoza delivery system. Circassia photo.

Circassia said it would satisfy the option payments and deferred consideration with third-party funding, or through a loan facility provided by AstraZeneca if third-party funding is unavailable.

Circassia will be responsible for promoting Tudorza while AstraZeneca will continue manufacturing it.

The drug, a powder formulation of aclidinium bromide, is indicated for the long-term maintenance treatment of bronchospasm associated with COPD. It is taken twice daily through oral inhalation.

NIOX Gets Boost for Asthma Monitoring

Earlier this month, Circassia announced news that could boost another of its products, NIOX, a technology for measuring fractional exhaled nitric oxide (FeNO) in asthma patients. FeNO monitoring is recommended in the latest Global Initiative for Asthma (GINA) guide, “Difficult-to-Treat & Severe Asthma in Adolescent and Adult Patients – Diagnosis and Management.”

The GINA guide focuses on difficult-to-treat and severe asthma, which can be particularly devastating to patients and costly to the healthcare system in terms of physician visits, medication, hospitalization and management of treatment side effects.

Acheson said NIOX provides objective and accurate FeNO measurement of airway inflammation and is the only such testing device in the U.S. available at point-of-care.

Earlier this year, major insurer Aetna updated its policy to deem FeNO monitoring by NIOX as “medically necessary” as a part of comprehensive asthma diagnosis and management, Acheson said.

“Today NIOX testing is considered affordable and accessible for both patients and their physicians, as more American lives have insurance coverage for FeNO testing,” he said.

Recruited to Morrisville in 2012

Circassia, headquartered in Oxford, England, was established in 2006. In March 2014 it completed an initial public offering on the London Stock Exchange. The company has operations in Sweden, Germany and China, and a global presence through a distributor network.

The company moved its U.S. headquarters from New Jersey to Morrisville in 2012 with financial incentives provided by the Town of Morrisville and assistance from other local partners including the North Carolina Biotechnology Center, the N.C. Department of Commerce, the N.C. Community College System, Wake County and the Morrisville Chamber of Commerce.

The Morrisville site employs about 50 people who work in management, customer service, accounting, marketing, training and other administration functions.

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