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10 Nov 2018

Hikma Pharmaceuticals and Vectura codevelopment and commercialization of GSK’s Breo Ellipta generics

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Hikma Pharmaceuticals and Vectura have signed a deal to develop and market generic versions of GlaxoSmithKline’s Ellipta portfolio, utilising the latter’s Open-Inhale-Close dry powder inhaler device.

Following interactions with US regulators, the firms believe the inhaler device has the potential to be developed as a 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 approximately $5.5 billion globally,” according to the press release.

Hikma and Vectura have agreed to develop and commercialise at least three of the portfolio products, with a substitutable generic version of Breo Ellipta (fluticasone furoate and vilanterol trifenatate) prioritised for the first wave of development.

“This agreement leverages the investment we have made and the experience we have gained through our generic Advair Diskus programme,” noted Siggi Olafsson, Hikma’s chief executive.

“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.”

Under the terms of the deal, Hikma will make an upfront payment of $15 million to Vectura, plus various other potential milestones of up to $75 million as well as a share of distributable net profit up to a mid teen percentage for each portfolio product.

Vectura is responsible for initial device and formulation development, while Hikma will be responsible for clinical development, regulatory submission and commercialisation.

“This is a highly significant and valuable agreement for Vectura, reflecting our increased focus in our complex inhaled generic portfolio,” said Vectura’s chief executive, James Ward-Lilley.

GSK’s patents for the Ellipta range are valid until 2021.

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