VEC.L Regulatory News (VEC)

Vectura Group plc

First launch of a product incorporating Vectura's FOX® smart nebuliser technology

Chippenham, UK - 5 April 2017: Vectura Group plc (LSE: VEC) ("Vectura", "the Group"), an industry-leading device and formulation business for inhaled airways products, confirms that its partner Bayer AG ("Bayer") has launched Breelib™, the new nebuliser for Ventavis® (iloprost), in Poland. BreelibTM has been developed by Bayer in collaboration with Vectura, adapting Vectura's FOX® handheld smart nebuliser device and utilising its unique flow rate and volume control technology. The launch triggers a €5 million milestone for the Group. Whilst the future financial value of this programme for the Group will be limited given the small patient population, this launch is an important validation of the FOX® technology and its future potential. Vectura is eligible to receive annual milestones on the anniversary of this first launch on a decreasing scale, over six years, to the total value of €5.75 million.

The application of Ventavis® with the Breelib™ nebuliser was approved by the European Medicines Agency in October 2016. Following the EC Declaration of Conformity, marketability of the medical device was granted by the EU Notified Body in December 2016.

The new BreelibTM device developed through this collaboration (VR876) with Bayer in the EU and Rest of World territories, excluding the US, has been designed to deliver Ventavis® at an optimal particle size and to allow for a breath-actuated nebulisation at a fixed volume and flow rate, utilising the FOX®'s unique flow rate and volume control technology and thereby improving delivery to the lungs. In a clinical trial that compared BreelibTM with a currently recommended nebuliser, the new device demonstrated a reduction in mean inhalation time of each inhalation from approximately 11 minutes to approximately 3 minutes, providing for a significant reduction in the overall daily treatment duration for patients. These clinical trial results will be published in due course.

James Ward-Lilley, Chief Executive Officer of Vectura:

"We are pleased to have supported Bayer in this collaboration enhancing drug delivery and ease of device usage for patients with pulmonary arterial hypertension. The launch of the Breelib device marks an important validation of Vectura's mesh based handheld device technology using the FOX smart nebuliser. Breelib's proprietary flow-rate and volume control system is also utilised in Vectura's jet based AKITA nebuliser platforms. Vectura expects to increase the utilisation of the mesh based nebuliser platforms with a number of further partnering collaborations."

- Ends -

Enquiries

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 seven inhaled, four non-inhaled and ten oral products marketed by partners with growing global royalty streams, and a portfolio of drugs in clinical development, a number of which have licence agreements with several global pharmaceutical and biotechnology companies including Hikma, Novartis, Sandoz, Mundipharma, Kyorin, Baxter, GSK, UCB, Ablynx, Grifols, Bayer, Chiesi, Almirall, Janssen, and Tianjin KingYork. For further information, please visit Vectura's website at www.vectura.com.

About BreelibTM

BreelibTM is a small handheld, battery-powered, breath activated, vibrating mesh technology inhalation system that has been developed by Bayer in collaboration with Vectura, adapting Vectura's FOX® smart nebuliser device and utilising its unique flow rate and volume control technology.

About FOX®

The FOX® device is a small handheld, self-contained, battery-powered inhalation system that delivers nebulised liquid drugs with high performance using a vibrating mesh technology. The mesh based aerosolisation engine is proprietary to Vectura. As with all of Vectura's smart nebuliser delivery systems, FOX® provides targeted inhalation therapy for applications where precise delivery to the lungs is needed. To achieve this, the device creates a liquid aerosol and co-ordinates delivery after the patient has inhaled using the FAVORITE (Flow And Volume Regulated Inhalation TEchnology) principle for precise delivery to the lungs. The FOX® inhalation system also makes use of a flow sensing/controlling valve system, is rechargeable and can be Bluetooth®-enabled. FOX® is CE marked and 510(k) approved and in April 2014, gained a Red Dot Award for product design.

About Ventavis®

Ventavis® is the first and currently only EMA-approved, inhaled prostacyclin therapy for the treatment of patients with PAH.1 Ventavis® offers a local, targeted option and is recommended as initial therapy for PAH patients in WHO FC III and IV in the current 2015 ESC/ERS guidelines.2 Studies have shown it to be a well-tolerated and effective treatment that can provide immediate and long-term relief of symptoms, with improved quality of life for patients with PAH.3,4 Due to its potent efficacy, low interaction potential and favourable safety profile Ventavis® is a combination partner in PAH therapy, recommended in sequential combination therapy with other PAH drugs for patients not responding adequately to monotherapy.1,2,4,5,6,7,8,9,10,11

Iloprost, the active substance of Ventavis®, is a synthetic prostacyclin analogue that was identified and developed at the Bayer research laboratories. Ventavis® dilates the blood vessels, allowing more blood flow through the arteries of the lung and lowering the blood pressure within the pulmonary arteries. This leads to an improved supply of oxygen to the body and reduced strain on the heart, enabling the heart to function more effectively and allowing patients to breathe more easily.1 The pulmonary selectivity of Ventavis® means it can give rapid relief of symptoms, with fewer systemic and administration-related side effects.25 Ventavis® slows clinical deterioration and significantly improves exercise capacity.3,4 Ventavis® improves quality of life and data indicate a positive impact on survival.3,4

Ventavis® is provided as a nebuliser solution. Inhaling aerosolized Ventavis® from a nebuliser into the lungs targets the diseased pulmonary vessels directly. The intermittent inhaled administration of Ventavis® gives dual benefits. One is the selective deposition of Ventavis® in the lung - guaranteeing rapid effect, good tolerability and a sustained improvement in physical exercise capacity and quality of life.3 The second is intrapulmonary selectivity that ensures vasodilation only in well ventilated areas of the lung where the gas exchange is taking place.25 This approach also avoids the potential dangers associated with invasive, indwelling intravenous catheters, which are necessary for continuous intravenous administration of prostanoids.

About Pulmonary Hypertension

Pulmonary Hypertension (PH) is a severe, progressive, life-threatening disorder of the lungs and heart in which the blood pressure in the pulmonary arteries is above normal, and which can lead to right heart failure and death.12,13 People with PH may develop a markedly decreased exercise capacity and a reduced quality of life.15 The most common symptoms of PH include shortness of breath, fatigue, dizziness and fainting, all of which are worsened by exertion.14,15 As the symptoms of PH are non-specific, diagnosis can be delayed by as much as two years.2,16,17 Early diagnosis and accurate identification of the PH types are essential as a delay in treatment initiation of even a few months can have a negative impact on survival.2,18 Continuous treatment monitoring by a PH specialist is vital to ensure that patients are receiving optimal care for their particular type and stage of disease.2 There are five different types of PH; each can affect the patient in a different way and every patient may have a different etiology of PH.2,19,20 For the best chance of success patients need to be treated at a PH specialist centre.3

About Pulmonary Arterial Hypertension (PAH)

Pulmonary arterial hypertension (PAH), one of the five types of PH, is a progressive and life-threatening disease in which the blood pressure in the pulmonary arteries is significantly increased due to vasoconstriction and which can lead to right heart failure and death.12,14 PAH is characterized by morphological changes to the endothelium of the arteries of the lungs causing remodeling of the tissue and vasoconstriction.12,13 As a result of these changes, the blood vessels in the lungs constrict, making it more difficult for the heart to pump blood through to the lungs.12,13 PAH is a rare disease and affects an estimated 15-52 people per million globally.12,15,21 It is more prevalent in women than men.21 In most cases, PAH has no known cause, though it can sometimes be inherited.22 In spite of several pharmacological treatment options for PAH having been available for over a decade, the prognosis for these patients has remained poor, resulting in the need for effective alternative treatment options.23,24 Currently, mortality of PAH patients remains high and is still 15% at 1 year and 32% at 3 years after diagnosis.23,24

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.

References

1 Ventavis Summary of Product Characteristics, EU.

2 Galié N, Humbert M, et al. The Joint Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS). European Heart Journal. 2015 doi:10.1093/eurheartj/ehv317. [Last accessed November 2016].

3 Olschewski et al. Long-term therapy with inhaled iloprost in patients with pulmonary hypertension. Respiratory Medicine 2010; 104, 731-740.

4 Olschewski H et al. Eur Resp Rev 2009; 18: 29-34.

5 McLaughlin VV et al. Am J Respir Crit Care Med 2006; 174: 1257-63.

6 Ghofrani HA et al. Ann Intern Med 2002; 136: 515-22.

7 Ghofrani HA et al. J Am Coll Cardiol 2003; 42: 158-64.

8 Ghofrani HA et al. N Engl J Med 2013; 369: 330-40.

9 Langleben D et al. Am J Resp Crit Care Med 187; 2013: A3532.

10 Benza RL et al. J Heart Lung Transplant 2007; 26: 437-56.

11 Krug S et al. Vasc Health Risk Manag 2009; 5: 465-74.

12 Macchia A, Marchioli R, Marfisi R et al. A meta-analysis of trials of pulmonary hypertension: a clinical condition looking for drugs and research methodology. Am Heart J 2007;153(6):1037-1047

13 Rosenkranz S. Clin Res Cardiol. 2007;96:527-41.

14 McKenna SP, Doughty N, Meads DM, Doward LC, Pepke-Zaba J. The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR): a measure of health-related quality of life and quality of life for patients with pulmonary hypertension. Qual Life Res 2006;15(1):103-115.

15 PHA Europe. The impact of pulmonary arterial hypertension (PAH) on the lives of patients and carers: results from an international survey. www.phaeurope.org/wp-content/uploads/PAH_Survey_FINAL.pdf. [Last accessed November 2016].

16 Armstrong I, Rochnia N, Harries C, Bundock S, Yorke J. The trajectory to diagnosis with pulmonary arterial hypertension: a qualitative study. BMJ Open 2012;2(2):e000806.

17 Peacock AJ. Treatment of pulmonary hypertension. BMJ 2003;326(7394):835-836.

18 Vachiery JL, Yerly P, Huez S. How to detect disease progression in pulmonary arterial hypertension. Eur Respir Rev 2012;21(123):40-47.

19 Ali JM, Hardman G, Page A, Jenkins DP. Chronic thromboembolic pulmonary hypertension: an underdiagnosed entity? Hosp Pract (1995 ) 2012;40(3):71-79.

20 Skoro-Sajer N, Mittermayer F, Panzenboeck A et al. Asymmetric dimethylarginine is increased in chronic thromboembolic pulmonary hypertension. Am J Respir Crit Care Med 2007;176(11):1154-1160.

21 Peacock AJ, Murphy NF, McMurray JJ, et al. An epidemiological study of pulmonary arterial hypertension. Eur Respir J. 2007;30:104-9.

22 PHA UK. What is pulmonary hypertension? www.phassociation.uk.com/what_is_ph/ [Last accessed November 2016].

23 Girgis RE. Emerging drugs for pulmonary hypertension. Expert Opin Emerg Drugs. 2010;15:71-85.

24 Benza RL, Miller DP, Barst RJ, et al. An evaluation of long-term survival from time of diagnosis in pulmonary arterial hypertension from the REVEAL Registry. Chest. 2012;142:448-56.

25 NICE MTA Submission. Inhaled iloprost (Ventavis) in the treatment of primary pulmonary hypertension. Schering Health Care Ltd. April 2007.