Novartis in Licensing Deal for COPD Products
By

Novartis has entered into an exclusive license agreement with Sunovion Pharmaceuticals, a biopharmaceutical company headquartered in Marlborough, Massachusetts and a wholly owned subsidiary of Osaka, Japan-based Sumitomo Dainippon Pharma, for the US commercialization rights to three approved medicines for treating chronic obstructive pulmonary disease (COPD).

The products involved in the agreement are 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 COPD.

Under the agreement, Sunovion has exclusive rights to market these three products in the US. Utibron Neohaler and Seebri Neohaler were approved by the US Food and Drug Administration (FDA) in 2015. Sunovion plans to bring these two products to market in 2017. Arcapta Neohaler was approved the FDA in 2011 and launched in 2012.

Novartis will continue to manufacture all three products under the agreement. In addition, Novartis and its affiliates will continue to retain commercialization rights for Ultibro Breezhaler, Seebri Breezhaler, and Onbrez Breezhaler outside of the US.

The transaction strengthen’s Sunovion’s COPD portfolio in the US. Sunovion’s COPD portfolio includes Brovana (arformoterol tartrate), a twice-daily nebulized long-acting beta agonist, and SUN-101/eFlow (glycopyrrolate), an investigational nebulized long-acting muscarinic antagonist for which Sunovion submitted a new application to the FDA in July 2016.

Source: Sunovion Pharmaceuticals 

Leave a Reply

Your email address will not be published.