Sunovion Pharmaceuticals announced its entry into a license agreement with Novartis for exclusive U.S. commercialization rights to three U.S. Food and Drug Administration (FDA)- approved and long-term treatments for airflow obstruction in people with chronic obstructive pulmonary disease (COPD).
The three Novartis medicines Sunovion is licensing U.S. marketing rights to are:
• Utibron Neohaler (indacaterol and glycopyrrolate) inhalation powder (27.5 mcg/15.6 mcg), a twice-daily combination long-acting beta agonist and long-acting muscarinic antagonist (LABA/LAMA) that is FDA-approved for long-term airflow obstruction treatment maintenance in persons with COPD.
• Seebri Neohaler inhalation powder (15.6 mcg), a LAMA whose active ingredient, glycopyrrolate, has a well-documented safety and efficacy profile, and in clinical trials has shown meaningful improvements in health-related quality of life and reduced use of rescue medications compared to placebo.
• Arcapta Neohaler (indacaterol) inhalation powder (75 mcg), a once-daily LABA approved for long-term, bronchodilator treatment maintenance of airflow obstruction in COPD patients that was FDA approved in 2011 and has been available in the U.S. since 2012.
Utibron Neohaler and Seebri Neohaler were approved by the FDA in 2015, and Sunovion intends to soon begin marketing them. Novartis will continue to manufacture the three licensed products under the terms of the agreement, and the company or its affiliates will retain commercialization rights for its Ultibro Breezhaler (indacaterol/glycopyrronium), Seebri Breezhaler (glycopyrronium) and Onbrez Breezhaler (indacaterol) outside of the U.S.
Sunovion claims the licensing deal with Novartis gives it the broadest U.S. portfolio of handheld and nebulized treatments for people at all stages of COPD, which also includes FDA approved twice-daily nebulized LABA Brovana (arformoterol tartrate), and SUN-101/eFlow (glycopyrrolate), an investigational nebulized LAMA currently the subject of a New Drug Application (NDA) that Sunovion submitted to the FDA in July 2016.
“Sunovion has a long-standing commitment to advancing respiratory health and to providing new treatment options for people with COPD,” David Frawley, Sunovion’s executive vice President and chief commercial officer, said in a press release. “We are pleased to add Utibron Neohaler, Seebri Neohaler, and Arcapta Neohaler to our respiratory portfolio, as these will complement our existing products and allow us to provide a wide range of treatment options for people with COPD.”
Long-acting bronchodilators — both LAMA and LABA — are currently a widely used first-line standard of care maintenance therapy for patients presenting with COPD symptoms, as outlined in the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017 Global Strategy for the Diagnosis, Management and Prevention of COPD. These medicines dilate the airways in the lungs to prevent COPD symptoms like wheezing, cough, excess production of mucus in the lungs, chest tightness, and shortness of breath. Sunovion says combined LAMA and LABA therapy may offer cumulative benefits, including increased efficacy, compared to either type used as monotherapy. Consequently, patients with increasing COPD symptoms severity are often treated with both a LAMA and a LABA.
According to the Centers for Disease Control and Prevention, COPD is the third leading cause of death after heart disease and cancers. The American Lung Association notes that COPD is also a major cause of disability, and while some 15.7 million Americans have a formal COPD diagnosis, an estimated 12 million more may have the disease and go undiagnosed.
COPD is a term that actually encompasses a range of conditions, but generally refers to permanent lung damage that gets worse over time. The disease can affect patients’ airways, air sacs, or both. The two most prevalent forms of COPD are chronic bronchitis and emphysema. Both cause airway blockage, resulting in shortness of breath, chronic productive coughing that produces large amounts of mucus, chest tightness and/or wheezing, among other symptoms.
Global Initiative for Chronic Obstructive Lung Disease (GOLD)
Centers for Disease Control and Prevention
American Lung Association