Vectura Group has inked an agreement with Hikma Pharmaceuticals to develop generic versions of GSK’s Ellipta portfolio utilising its proprietary Open-Inhale-Close dry powder inhaler device.
Vectura is paying $15 million upfront, with the potential of up to $80 million of development milestone payments.
Following interactions with US 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.
This presents a significant opportunity, with net sales for Ellipta products in the US projected to be $4 billion by 2024 and over $5.5bn globally.
James Ward-Lilley, Vectura CEO, 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 programme.”
The Open-Inhale-Close dry powder inhaler programme includes the development of AB-rated substitutable generics of up to five GSK respiratory medicines.
Vectura and Hikma have agreed to develop and commercialise at least three of the portfolio products. A substitutable generic version of Breo Ellipta (fluticasone furoate and vilanterol trifenatate) will be prioritised for the first wave of development.
Pharmaceutical and device development work has progressed in parallel with partnering discussions. The new device is an evolution of Vectura’s lever-operated multi-dose [LOMI] device and builds on Vectura and Hikma’s shared experience with the VR315[US] programme, enabling accelerated development under this new agreement.