Vectura Announces Major New Tiotropium Bromide PI Development Programme Accelerated Through Licensing of Pulmatrix Technology

Vectura Group plc VEC ("Vectura", "the Group"), an industry-leading device and formulation business for inhaled airways products, today announces it is progressing the development of a branded generic tiotropium bromide programme (VR410) for the US market, which will be accelerated through an exclusive licence agreement with Pulmatrix Inc. PULM. Pulmatrix is a clinical-stage biopharmaceutical company that has been developing PUR0200, its once-daily, inhalable iSPERSE formulation of tiotropium bromide for COPD patients.

 

VR410

 

Vectura's innovative dry power inhaler ("DPI") device technology will be used to deliver PUR0200. VR410 is a branded generic alternative to Spiriva

 

HandiHaler

 

1 in the US.

 

In addition, under the agreement Vectura may develop the PUR0200 formulation in combination with one or more other active pharmaceutical ingredients. This provides Vectura with the opportunity for future additional combination assets to compete in the growing US LAMA/LABA market, worth $407m in 2016 2. This development will be actively pursued once

the monotherapy project is established.

 

Pulmatrix will provide the data package for PUR0200 and assist with the transfer of development and manufacturing activities to Vectura. As part of the agreement, a technology access fee of $1 million will be payable to Pulmatrix upon successful achievement of pre-agreed pharmaceutical development criteria, which will be capitalised as an intangible asset and amortised in line with the requirements of IFRS.

 

Vectura will commence development immediately and then plans to license VR410 and future VR410 assets to partners who would fund the remaining development and undertake commercialisation activities. After partnering, Vectura would pay Pulmatrix a mid-teen percentage share of any future revenues that Vectura receives from partners relating to the development and sale of VR410 and VR410-related products, including any future combinations.

 

The Group does not expect a material impact on R&D expenditure for the feasibility study and early development prior to licensing.

 

James Ward-Lilley, Chief Executive Officer, commented:

 

"With this agreement Vectura now has active substitutable or branded generic development programmes for all the major established inhaled products in the US market. Tiotropium is one of the largest opportunities in the inhaled respiratory market and the agreement with Pulmatrix enables Vectura to accelerate its plans for both monotherapy and combination programmes. The development of inhaled generics requires specialised capabilities which are scarce in the industry but are core competencies of Vectura. Today's announcement is part of the expanded generic portfolio enabled through the merger of Vectura and Skyepharma."