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Vectura Group announces global agreement with Hikma to develop generic versions of GSK’s Ellipta® portfolio

08 Nov 18

-        Upfront payment of US$15m

-        Up to US$80m of development milestone payments

-        Mid teen percentage profit share arrangement for each portfolio product

Chippenham, UK – 08 November 2018: Vectura Group plc (LSE: VEC) ("Vectura", "the Group"), today announces signing an agreement with Hikma Pharmaceuticals PLC ("Hikma") for the global development and commercialisation of generic versions of GSK’s Ellipta® portfolio, utilising Vectura’s proprietary Open-Inhale-Close dry powder inhaler device.

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 $4bn by 2024 and over $5.5bn globally[1]. 

 

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 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. Details of product specific launch timings will be provided as development progresses.

 

Financial Considerations

Upon signing Vectura will receive an upfront payment of US$15m and estimate £5m [US$6.5m] of this revenue to be recognised in 2018. Vectura will be responsible for, and fund, initial device and formulation development. Hikma will be responsible for clinical development, regulatory submission and commercialisation activities. Transfer of the first product to Hikma’s manufacturing facility to enable clinical manufacturing, will trigger a $5m milest

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