Vectura Group partner Hikma Pharmaceuticals has launched its generic version of GlaxoSmithKline’s Advair Diskus (fluticasone propionate and salmeterol inhalation powder), 100 mcg/50 mcg and 250 mcg/50 mcg doses, in the US.
As a result of the product’s FDA approval, Vectura will receive a payment of $11m which will be recognised in 2020, and will earn a mid-teen royalty on net sales of the product.
Hikma’s powder is indicated for the treatment of asthma, the maintenance treatment of airflow obstruction, and for reducing exacerbations in patients with chronic obstructive pulmonary disease. It’s delivered using Vectura’s proprietary lever-operated multi-dose inhaler device technology.
This marks the first US FDA approval of a Vectura dry powder inhaler and joins Vectura’s portfolio of approved inhalation devices in Europe and globally, such as GyroHaler and FOX.
Will Downie, CEO of Vectura, said, “This is excellent news for Vectura and for people living with asthma and COPD in the US. Approval of this high quality substitutable generic product for Advair Diskus validates Vectura’s rare, industry-leading development capabilities and the strong partnership we have with Hikma. Approval of this product paves the way for our substitutable drug-device combination programme, also partnered with Hikma, for generic versions of the GSK Ellipta portfolio, in the coming years.”