Vectura Group plc has signed an agreement with Hikma Pharmaceuticals PLC for the global development and commercialization of generic versions of GSK’s Ellipta portfolio, using Vectura’s Open-Inhale-Close dry powder inhaler device.
 
Following interactions with FDA, the Open-Inhale-Close dry powder inhaler device has the potential to be developed as an AB-rated substitutable drug-device combination for generic versions of the GSK Ellipta portfolio, which had sales of in the U.S. projected to be $4 billion by 2024. 
 
The companies have agreed to develop and commercialize at least three of the portfolio products. A generic version of Breo Ellipta will be prioritized. The new device builds on Vectura and Hikma’s shared experience with the VR315[US] program, enabling accelerated development under this new agreement.  
 
Vectura will receive an $15 million upfront and will be responsible for initial device and formulation development. Hikma will be responsible for clinical development, regulatory submission and commercialization. Transfer of the first product to Hikma’s manufacturing facility to enable clinical manufacturing, will trigger a $5 million milestone. Vectura will receive milestones of as much as $75 million upon achieving key development milestones.
 
James Ward-Lilley, chief executive officer of Vectura, said, “This is a highly significant and valuable agreement for Vectura, reflecting our increased focus in our complex inhaled generic portfolio. The agreement validates Vectura’s rare, industry-leading development capabilities. It also reflects the strong existing relationship we have with Hikma and their confidence in the future of the substitutable inhaled generic segment including VR315 our joint Advair generic program.”