Chippenham, UK – 24 January 2017: Vectura Group plc (LSE: VEC) (“Vectura”, “the Group”), an industry-leading device and formulation business for inhaled airways disease, has received an Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) to conduct a Phase 1 clinical trial with VR647.
VR647
Wholly-owned “smart” nebuliser programme in paediatric asthma
VR647 is a drug/device combination, using the AKITA® JET smart nebuliser, for the delivery of nebulised budesonide for maintenance treatment and prophylactic therapy of asthma in children (12 months to 8 years) for the US market. This wholly-owned pipeline programme seeks to significantly improve the currently available nebulised delivery of budesonide with a faster delivery time and better lung deposition where there is potential for reducing the dosage whilst maintaining similar efficacy, thereby reducing the risk of local and systemic side effects.
In June 2015 the FDA agreed with the Group’s plan to rely on the 505(b)(2) pathway for the development programme with the aim of filing a New Drug Application (NDA). This approach requires a small number of clinical studies whose costs are within the Group’s existing guidance for R&D investment. In line with its existing strategy to selectively build a specialist sales capability alongside the Group’s continuing and proven partnering model, VR647 offers a further potentially significant source of recurring revenue. According to IMS, US sales of nebulised budesonide are approximately $830m[1] per year.
The Phase I pharmacokinetic study in adults is expected to be initiated in H1 2017 and will inform the doses to be explored in a Phase 2 study in children planned for H2 2017. These studies will be conducted to support initiation of a Phase III study in H2 2018 with the NDA filing anticipated in 2020.
James Ward-Lilley, Chief Executive Officer, commented:
“VR647 offers substantial potential harnessing of Vectura’s innovative smart nebuliser technology for superior delivery of an existing drug with a proven track record in an established and significant US market. The FDA’s approval is an important milestone allowing us to commence an accelerated clinical programme ahead of potential launch in 2021 as a self-commercialised asset.”
VR647
Wholly-owned “smart” nebuliser programme in paediatric asthma
VR647 is a drug/device combination, using the AKITA® JET smart nebuliser, for the delivery of nebulised budesonide for maintenance treatment and prophylactic therapy of asthma in children (12 months to 8 years) for the US market. This wholly-owned pipeline programme seeks to significantly improve the currently available nebulised delivery of budesonide with a faster delivery time and better lung deposition where there is potential for reducing the dosage whilst maintaining similar efficacy, thereby reducing the risk of local and systemic side effects.
In June 2015 the FDA agreed with the Group’s plan to rely on the 505(b)(2) pathway for the development programme with the aim of filing a New Drug Application (NDA). This approach requires a small number of clinical studies whose costs are within the Group’s existing guidance for R&D investment. In line with its existing strategy to selectively build a specialist sales capability alongside the Group’s continuing and proven partnering model, VR647 offers a further potentially significant source of recurring revenue. According to IMS, US sales of nebulised budesonide are approximately $830m[1] per year.
The Phase I pharmacokinetic study in adults is expected to be initiated in H1 2017 and will inform the doses to be explored in a Phase 2 study in children planned for H2 2017. These studies will be conducted to support initiation of a Phase III study in H2 2018 with the NDA filing anticipated in 2020.
James Ward-Lilley, Chief Executive Officer, commented:
“VR647 offers substantial potential harnessing of Vectura’s innovative smart nebuliser technology for superior delivery of an existing drug with a proven track record in an established and significant US market. The FDA’s approval is an important milestone allowing us to commence an accelerated clinical programme ahead of potential launch in 2021 as a self-commercialised asset.”
