Vectura Group has announced its partner Hikma Pharmaceuticals has launched its generic version of GlaxoSmithKline’s Advair Diskus®1 (fluticasone propionate and salmeterol inhalation powder), 100mcg/50mcg and 250mcg/50mcg doses, in the US. The launch of the product follows approval by the US Food and Drug Administration (FDA).
As a result of this approval, Vectura will receive a milestone payment of $11m which will be recognized in 2020, and will earn a mid-teen royalty on net sales of the product.
Hikma’s fluticasone propionate and salmeterol inhalation 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 is delivered using Vectura’s proprietary lever-operated multi-dose inhaler (LOMI) device technology.
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This marks the first US FDA approval of a Vectura dry powder inhaler and joins the growing Vectura franchise of approved inhalation devices in Europe and Rest of World such as GyroHaler® and FOX®.
“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.” He added, “Approval of this product paves the way for our substitutable drug-device combination program, also partnered with Hikma, for generic versions of the GSK Ellipta® portfolio, in the coming years,” Will Downie, Chief Executive Officer of Vectura, said.