MARLBOROUGH, Mass.--(BUSINESS WIRE)--Sunovion Pharmaceuticals Inc. (Sunovion) today announced that it has entered into an exclusive license agreement with Novartis for the U.S. commercialization rights to three approved medicines, Utibron™ Neohaler® (indacaterol and glycopyrrolate) inhalation powder (27.5 mcg/15.6 mcg), Seebri™ Neohaler® (glycopyrrolate) inhalation powder (15.6 mcg) and Arcapta® Neohaler® (indacaterol) inhalation powder (75 mcg), which are indicated for the long-term, maintenance treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD). With this transaction, Sunovion now has the broadest COPD portfolio in the U.S., providing handheld and nebulized treatment options for people with all stages of COPD.terms of the agreement, Sunovion has the exclusive rights to market Utibron™ Neohaler®, Seebri™ Neohaler® and Arcapta®Neohaler® in the U.S. Utibron™ Neohaler® and Seebri™ Neohaler®were approved by the U.S. Food and Drug Administration (FDA) in 2015, and Sunovion plans to bring them to market in 2017. Arcapta®Neohaler® was approved in the U.S. in 2011 and made available to people with COPD in 2012. Novartis will continue to manufacture these three medicines under the terms of the agreement. Novartis and its affiliates will continue to retain the commercialization rights for Ultibro®Breezhaler® (indacaterol/glycopyrronium), Seebri® Breezhaler®(glycopyrronium) and Onbrez® Breezhaler® (indacaterol) outside of the U.S.
“Sunovion has a long-standing commitment to advancing respiratory health and to providing new treatment options for people with COPD,” said David Frawley, Executive Vice President and Chief Commercial Officer, Sunovion. “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.”
Sunovion’s COPD portfolio includes Brovana® (arformoterol tartrate), an FDA approved twice-daily nebulized long-acting beta agonist (LABA), and SUN-101/eFlow® (glycopyrrolate), an investigational nebulized long-acting muscarinic antagonist (LAMA), for which Sunovion submitted a New Drug Application (NDA) to the FDA in July 2016.
Utibron™ Neohaler®, Seebri™ Neohaler®, and Arcapta® Neohaler® are delivered by the Neohaler®, a handheld dry powder inhaler device.
About LAMAs and LABAs
Long-acting bronchodilators currently are the first-line standard of care maintenance therapy for symptomatic patients with COPD.1 Within that class there are long-acting muscarinic antagonists (LAMAs) and long-acting beta agonists (LABAs), both of which are widely used and important therapeutic approaches. LAMA and LABA medicines dilate, or open, the airways in the lungs to prevent symptoms such as wheezing, cough, chest tightness and shortness of breath. Combining a LAMA and a LABA may offer additive benefits, including increased efficacy, compared with a LAMA or LABA alone. As a result, patients with increasing severity are often treated with both a LAMA and LABA.
About COPD
Chronic obstructive pulmonary disease, also known as COPD, includes chronic bronchitis and emphysema, and is a progressive respiratory disease that causes worsening obstruction to airflow in the lungs over time.2 Approximately 15.7 million adults in the U.S. report that they have been diagnosed with COPD.3 It is estimated that several million more adults have undiagnosed COPD.4 COPD is responsible for over 120,000 deaths per year, making it the third leading cause of death in the U.S.3 COPD develops slowly and the symptoms often worsen over time, potentially limiting the ability to perform routine activities.1 Symptoms of COPD include coughing, wheezing, shortness of breath, excess production of mucus in the lungs, the inability to breathe deeply and the feeling of being unable to breathe.3 The symptoms of COPD can be most severe during the night and early morning.5 Morning symptoms can be associated with limitation of activities during the day, impaired health status and increased risk of exacerbation.6 Night-time symptoms disturb sleep, reduce sleep quality and, in the long term, may be associated with development or worsening of cardiovascular diseases, cognition, depression and increased mortality.7
About Utibron™ Neohaler® (indacaterol and glycopyrrolate) Inhalation Powder
Utibron™ Neohaler®(indacaterol and glycopyrrolate) Inhalation Powder is a twice-daily combination long-acting beta agonist and long-acting muscarinic antagonist (LABA/LAMA) approved in the U.S. for the long-term maintenance treatment of airflow obstruction in people with COPD, including chronic bronchitis and/or emphysema. Phase 3 clinical trials demonstrated that Utibron™ Neohaler® offers the additive benefits of the LABA indacaterol and the LAMA glycopyrrolate compared to each component alone. Utibron™ Neohaler® also showed clinically meaningful improvements in health-related quality of life and reduced use of rescue medication compared to placebo in the trials. Health status was assessed using the St. George's Respiratory Questionnaire (SGRQ)8 total score, which is a composite of symptoms, activities and impact on daily living.
The most common adverse reactions (?1% and more common than placebo) reported in two 12-week clinical trials with Utibron™ Neohaler® (and placebo) were: nasopharyngitis, 4.1% (1.8%); hypertension, 2.0% (1.4%); back pain, 1.8% (0.6%); oropharyngeal pain, 1.6% (1.2%).
For additional information, please see Utibron™ Neohaler® Full Prescribing Information including Box Warning and Medication Guide at http://utibron.sunovion.com.
About Seebri™ Neohaler® (glycopyrrolate) Inhalation Powder
Seebri™ Neohaler® (glycopyrrolate) Inhalation Powder is a twice-daily long-acting muscarinic antagonist (LAMA) approved in the U.S. for the long-term maintenance treatment of airflow obstruction in people with COPD, including chronic bronchitis and/or emphysema. Seebri™ Neohaler® is delivered by a dry powder inhaler (DPI), and its active ingredient, glycopyrrolate, has a well-documented safety and efficacy profile. In clinical trials, Seebri™ Neohaler® showed clinically meaningful improvements in health-related quality of life and reduced use of rescue medication compared to placebo. Health status was assessed using the St. George's Respiratory Questionnaire (SGRQ) total score, which is a composite of symptoms, activities and impact on daily living.
The most common adverse reactions (?1% and more common than placebo) reported in two 12-week clinical trials with Seebri™ Neohaler® (and placebo) were: upper respiratory tract infection, 3.4% (2.3%); nasopharyngitis, 2.1% (1.9%); urinary tract infection, 1.4% (1.3%); sinusitis, 1.4% (0.7%); oropharyngeal pain, 1.8% (1.2%).
Please see full Prescribing Information for Seebri™ Neohaler® at http://seebri.sunovion.com.
About Arcapta® Neohaler® (indacaterol) Inhalation Powder
Arcapta® Neohaler® (indacaterol) Inhalation Powder is a once-daily long-acting beta agonist (LABA) approved for the long-term, maintenance bronchodilator treatment of airflow obstruction in patients with COPD, and has been available in the U.S. since 2012. The product provides proven efficacy with once daily dosing and 24-hour bronchodilation.
Health-related quality of life was measured using the St. George’s Respiratory Questionnaire (SGRQ) in the confirmatory COPD clinical trials. SGRQ is a disease-specific patient reported instrument which measures symptoms, activities, and its impact on daily life. At week 12, pooled data from these trials demonstrated an improvement over placebo in SGRQ total score of -3.8 with a 95% confidence interval (CI) of (-5.3, -2.3) for the ARCAPTA NEOHALER 75 mcg dose.
Most common adverse reactions (>2% and more common than placebo) associated with Arcapta Neohaler® 75 mcg use in the three month pivotal studies were cough (6.5%), oropharyngeal pain (2.2%), nasopharyngitis (5.3%), headache (5.1%) and nausea (2.4%).
For additional information, please see Arcapta® Neohaler® Full Prescribing Information including Box Warning and Medication Guide at http://arcapta.sunovion.com.
About Brovana ® (arformoterol tartrate) Inhalation Solution
Brovana® (arformoterol tartrate) Inhalation Solution is indicated for the long-term, twice-daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. BROVANA is for use by nebulization only.
