VEC.L Regulatory News (VEC)

Vectura Group plc

Vectura announces major new tiotropium bromide DPI development programme accelerated through licensing of Pulmatrix technology

Chippenham, UK - 6 September 2017: 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"). 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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About Vectura

Vectura, a FTSE250 company listed on the London Stock Exchange (LSE: VEC), is an industry-leading device and formulation business for inhaled airways products offering a uniquely integrated inhaled drug delivery platform. With our extensive range of device and formulation technologies, integrated capabilities and collaborations, we are a leader in the development of inhalation products, increasing our ability to help patients suffering from respiratory diseases. 

Vectura has eight inhaled, four non-inhaled and ten oral products marketed by partners with growing global royalty streams. The group has a diverse portfolio of drugs in clinical development, including a number of novel and generic programmes which are partnered with several global pharmaceutical and biotechnology companies including Hikma, Novartis, Sandoz, Mundipharma, Kyorin, Baxter, GSK, UCB, Ablynx, Grifols, Bayer, Chiesi, Almirall, Janssen, Dynavax and Tianjin KingYork along with two wholly owned nebulised development programmes.

About tiotropium bromide

Tiotropium bromide is the active ingredient in Spiriva®. Tiotropium bromide is a once-daily, inhaled, long-acting muscarinic receptor antagonist (LAMA), used as maintenance therapy to control symptoms of chronic obstructive pulmonary disease (COPD). Gross US sales and volumes for the LAMA class in 2016 were $3.6bn and 13.3m units respectively, dominated by tiotropium bromide[3]. Tiotropium bromide is the active ingredient in Spiriva® Handihaler®, in the US market the last Orange Book[4] listed patent currently expires on Apr 19, 2030. Total US Spiriva sales in 2016 were $1.9bn.[5]

About PUR0200

PUR0200 is Pulmatrix's once-daily, inhalable iSPERSE™ reformulation of tiotropium bromide for COPD patients. PUR0200 may be developed as a branded alternative to Spiriva® HandiHaler® in the US.

About Pulmatrix

Pulmatrix is a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary disease using its patented iSPERSE™ technology. The Company's proprietary product pipeline is focused on advancing treatments for rare diseases, including PUR1900, an inhaled anti-fungal for patients with cystic fibrosis (CF) and severe asthma, and PUR1800, a narrow spectrum kinase inhibitor for patients with COPD. In addition, Pulmatrix is pursuing opportunities in major pulmonary diseases through collaborations, including PUR0200, a branded generic in clinical development for COPD. Pulmatrix's product candidates are based on iSPERSE™, its proprietary dry powder delivery platform, which seeks to improve therapeutic delivery to the lungs by maximising local concentrations and reducing systemic side effects to improve patient outcomes.

Forward-looking statements

This press release contains forward-looking statements, including statements about the discovery, development and commercialisation of products. Various risks may cause Vectura's actual results to differ materially from those expressed or implied by the forward-looking statements, including: adverse results in clinical development programmes; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialise products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialisation activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.