Vectura to get $10 million milestone as Hikma files ANDA for generic copy of GSK’s asthma drug
Vectura Group (LSE: VEC) on Friday said it is set to receive $10 million in milestone payments from partner Hikma Pharmaceuticals (LSE: HIK) after the latter filed an abbreviated new drug application (ANDA) for the generic version of GlaxoSmithKline’s (LSE: GSK) asthma drug.
Vectura has partnered with Hikma to develop the drug compound VR315 US to treat asthma and as maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). The drug is delivered using Vectura’s inhaler.
The company said the launch will be a major value driver for Vectura.
Vectura’s Chief Executive James Ward-Lilley, says: “The FDA acceptance of the ANDA filing is an important regulatory step for our VR315 programme,” adding, “We believe that the strong data package submitted will facilitate the approval of VR315 and gives us confidence that Hikma can be among the first companies to launch this product in the US.”
The US Food and Drug Administration (FDA) has set a GDUFA goal date of 10 May, 2017 for Hikma.