Hikma, Vectura to develop generic versions of GSK’s Ellipta portfolio

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Hikma, Vectura to develop generic versions of GSK’s Ellipta portfolio

By Sandra Levy - 11/09/2018
Hikma Pharmaceuticals has signed an agreement with Vectura Group for the global development and commercialization of generic versions of GlaxoSmithKlines’s Ellipta portfolio, which will utilize Vectura’s proprietary “open-inhale-close” dry powder inhaler device.

“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 program,” Hikma CEO Siggi Olafsson said in a statement. “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.”

Vectura and Hikma believe the open-inhale-close dry powder inhaler device has the potential to be developed as a drug-device combination for generic versions of the GSK Ellipta portfolio.

Net sales for Ellipta products in the United States are projected to be $4 billion by 2024 and approximately $5.5 billion globally, the company said.

The open-inhale-close dry powder inhaler program includes the development of generics of up to five GSK respiratory medicines.

Hikma and Vectura have agreed to develop and commercialize at least three of the portfolio products. A generic version of Breo Ellipta (fluticasone furoate and vilanterol trifenatate) will be prioritized for the first wave of development. Pharmaceutical and device development work has progressed in parallel with partnering discussions.

The new device, an evolution of Vectura’s lever-operated multidose device, builds on Vectura and Hikma’s shared experience with the generic Advair Diskus program, enabling accelerated development under this new agreement.

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