Sunovion Pharmaceuticals and Novartis have entered a commercialization agreement for three drugs approved by the U.S. Food and Drug Administration (FDA) indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).
Utibron Neohaler (indacaterol and glycopyrrolate) inhalation powder (27.5 mcg/15.6 mcg) and Seebri Neohaler (glycopyrrolate) inhalation powder (15.6 mcg) were approved by the FDA in 2015, and Arcapta Neohaler (indacaterol) inhalation powder (75 mcg) was approved in 2011 and launched in the U.S. by Novartis in 2012.
Utibron Neohaler is a combination of indacaterol, a long-acting beta2-adrenergic agonist (LABA), and glycopyrrolate, an anticholinergic indicated for the long-term, maintenance treatment of airflow obstruction in patients with COPD. Seebri Neohaler is an anticholinergic, and Arcapta is a long-acting LABA, both indicated for the treatment of the same clinical condition. The medicines are taken with a handheld inhaler device to improve lung function in COPD patients.
Under the terms of this agreement, Sunovion will have exclusive market rights of the three COPD medicines in the U.S., a move that will give it the broadest COPD portfolio in the country, offering therapeutic options for people with all stages of the disease.
Novartis will continue to manufacture the three products — Ultibro Breezhaler (indacaterol/glycopyrronium), Seebri Breezhaler (glycopyrronium) and Onbrez Breezhaler (indacaterol) — outside the U.S.
“Sunovion has a long-standing commitment to advancing respiratory health and to providing new treatment options for people with COPD,” David Frawley, Executive Vice President and Chief Commercial Officer, Sunovion, said in a recent press release. “We are pleased to add UtibronTM Neohaler®, SeebriTM 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 has its own FDA-approved COPD treatment — Brovana — on the market. Brovana Inhalation Solution is a long-acting LABA, used as a long-term, maintenance therapy to prevent and decrease shortness of breath (dyspnea) and wheezing in patients with COPD.
The company is also the developer of SUN-101 (glycopyrrolate), a LAMA delivered using the eFlow nebulizer closed system. The FDA began to review a New Drug Application for SUN-101 as a therapy for adults with COPD in October 2016.