Press release
Oct 20, 2017

Seebri™ Neohaler® (glycopyrrolate) Inhalation Powder is Now Available in the United States

SEEBRI™ NEOHALER® is a long-acting muscarinic antagonist (LAMA) for people with chronic obstructive pulmonary disease (COPD)

Tokyo, Japan – 20 October 2017: Sosei Group Corporation (“Sosei”); TSE Mothers Index:4565) is pleased to confirm that Sunovion Pharmaceuticals Inc. (Marlborough, Mass.,) announced that Seebri™ Neohaler® (glycopyrrolate) (“Seebri™”) Inhalation Powder, 15.6 mcg twice daily, is now available at pharmacies in the U.S. for the long-term maintenance treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Seebri™ is a long-acting muscarinic antagonist (LAMA). The announcement builds upon Sunovion’s launch in April 2017 of Utibron™ Neohaler® (indacaterol/glycopyrrolate) (“Utibron™”), a dual-bronchodilator (LAMA/LABA) handheld inhaler for the long-term maintenance treatment of airflow obstruction in people with COPD.

Sunovion entered into an exclusive license agreement with Novartis for the U.S. commercialization rights to Seebri™, as well as Utibron™ and Arcapta® Neohaler®, on 21 December 2016. Novartis received approval from the U.S. Food and Drug Administration (FDA) for Seebri™ in October 2015.

Sosei is eligible to receive royalties from Novartis on net sales of the product as well as certain milestones based on global calendar year combined net sales of Utibron™, Seebri™, Ultibro® Breezhaler® and Seebri® Breezhaler®. The royalties earned upon net sales of Seebri™ are the same as those for Seebri® Breezhaler®.

Commenting on the announcement, Peter Bains, CEO at Sosei, said: “We are pleased with today’s confirmation of the U.S. market launch of Seebri™ by Sunovion. Seebri™ is an important addition to Sunovion’s growing portfolio of specialty respiratory products, and follows on from its successful U.S. launch of Utibron™ earlier this year. We believe Sunovion will be highly effective in the commercialisation of Seebri™ and its broader portfolio given its strong established U.S. respiratory franchise and track record in COPD.

“Royalties earned from sales of Seebri™ in the U.S. will make a further contribution to the substantial royalty stream we already receive from Novartis for sales of Ultibro® Breezhaler® and Seebri® Breezhaler® in Europe and the Rest of the World, and from the sales by Sunovion of Utibron™ in the U.S.”

Ultibro® Breezhaler®, Seebri® Breezhaler®, UtibronTM Neohaler®, Seebri™ Neohaler® are trademarks of Novartis AG.