Hikma Pharmaceuticals has signed an agreement with Vectura Group for the worldwide development and commercialization of the generic versions of GSK's Ellipta portfolio.
GSK’s Ellipta portfolio will be commercialized using Vectura’s Open-Inhale-Close dry powder inhaler device.
Hikma said after interactions with the US FDA, the companies believe 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 Ellipta portfolio.
The Open-Inhale-Close dry powder inhaler program includes the development of AB-rated substitutable generics of up to five of GSK’s respiratory medicines.
Hikma and Vectura will develop and commercialize at least three of the portfolio products.
A substitutable generic version of Breo Ellipta (fluticasone furoate and vilanterol trifenatate) will be prioritized in the first wave of development.
Pharmaceutical and device development work is also progressing in parallel with partnering discussions. The new device is claimed to be the next step of Vectura’s lever-operated multi-dose (LOMI) device and builds on Vectura and Hikma’s shared experience with the generic Advair Diskus programme. This can enable for accelerated development under the new agreement.
Hikma Pharmaceuticals CEO Siggi Olafsson said: “The generic respiratory market is a key area of pipeline focus for Hikma. This agreement leverages the investment we have made and the experience we have gained through our generic Advair Diskus programme.
“By strengthening and expanding our partnership with Vectura, we will develop a pipeline of complex respiratory products that will enable us to deliver sustainable long-term growth.”
As per the agreement, Hikma will make an upfront payment of $15m to Vectura.
Vectura will be responsible for, and fund, initial device and formulation development.
Hikma will be responsible for clinical development, regulatory submission and commercialization.
After transferring the first product to Hikma’s manufacturing facility for clinical manufacturing, Hikma will $5m milestone payment to Vectura.
After this time, Hikma will make milestone payments of up to $75m across several stages of development including the delivery of pharmacokinetic clinical trials, pivotal clinical trials, ANDA submissions and FDA approvals.