Vectura Group plc (LSE: 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. (NASDAQ:
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."
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