Vectura Group plc Vectura Announces VR647 Positive Findings (3579Y)

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RNS Number : 3579Y

Vectura Group plc

21 August 2018

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Vectura Group announces positive findings from its VR647 Phase II pharmacokinetic and mouthpiece methodology studies

Validating technology platforms and enabling progression of Phase III programme

Chippenham, UK - 21 August 2018: Vectura successfully concludes two paediatric studies to support the potential use of VR647, its wholly-owned drug/device combination asset.

The first study evaluated the pharmacokinetics of budesonide delivered using Vectura's VR647 Inhalation System to paediatric asthma patients between four and eight years of age. The second study was a methodology study, designed to evaluate the ability of children from one to four years of age to use the VR647 Inhalation System with a mouthpiece.

The pharmacokinetic and methodology studies suggests that the VR647 Inhalation System may reduce delivery times and potentially reduce steroid dose, versus marketed nebulised treatments in children with asthma. The trials investigated children across different age settings, and results from both studies provide high confidence in the programme, supporting the progression of VR647 to a Phase III programme.

Pharmacokinetic Study

This US study investigated 17 paediatric patients from four to eight years of age with symptoms suggestive of asthma. Pharmacokinetics were obtained for three different budesonide doses delivered with the VR647 Inhalation System and an approved 1mg budesonide dose delivered using a marketed nebuliser.

Highlights:

-- Budesonide pharmacokinetics indicate that the VR647 Inhalation System can achieve the same lung deposition in children with a lower delivered dose than the marketed nebuliser delivery system without compromising exposure or safety.

-- Potential to reduce budesonide treatment time by 50% or more in children using the VR647 Inhalation System, compared with the marketed product tested.

These results, subject to discussions with the FDA, will define the dosing regimens to be tested in the pivotal Phase III program to evaluate the efficacy and safety of VR647 Budesonide Inhalation Suspension delivered by the VR647 Inhalation System.

Methodology study

This study assessed the ability of 40 children from one to four years of age (inclusive) to use the VR647 Inhalation System successfully, with a mouthpiece to inhale a fixed volume of aerosol.

The study also evaluated the impact of the age of the child on their need for hands-on support from a parent or caregiver.

Highlights:

-- Despite the current belief that children under 4 years of age are unable to effectively use a mouthpiece, this trial demonstrates that children >2 years of age are able to use the VR647 Inhalation System with a mouthpiece.

A mouthpiece is an efficient and convenient patient/nebuliser interface that allows a tight control of the breathing pattern with no loss of medication. Vectura is also developing a facemask for children under 2 years of age.

Dr. Gonzalo de Miquel, Executive Vice President and Chief Medical Officer, Vectura, commented: "There are very few approved treatment options for children under 5 years of age. The results of these studies support Vectura's confidence in our wholly-owned VR647 product as a more convenient treatment option for children. This product has the potential to reduce treatment times and the steroid burden for this patient population, without compromising exposure or safety. We look forward to outlining Phase III plans with the FDA at the end of the year."

Dr. Leonard Bacharier, Professor of Paediatrics and Medicine at Washington University School of Medicine, commented: "These studies provide very encouraging and positive data, as they demonstrate that the VR647 Inhalation System, with the mouthpiece, can easily be used by young children. The real-time feedback and inhalation control with the VR647 Inhalation System is a new way of treating asthmatic children with budesonide, and has the potential to improve compliance and efficacy in a patient population with limited therapy options."

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Meet The Expert Call

Dr. Gonzalo de Miquel, Executive Vice President and Chief Medical Officer, Vectura, will be joined by Dr. Leonard Bacharier, Professor of Paediatrics and Medicine at Washington University School of Medicine, for a live conference call today at 14.30 BST/9:30 EDT to discuss the VR647 development programme and the results of the two trials. There will be a short presentation followed by an expert discussion on next steps for VR647. A copy of the presentation will be available on Vectura's website 30 minutes before the call. Link: http://www.vectura.com/investors/presentations-webcasts/

Dial-in details:

Participant local dial-in: 020 7192 8000 (UK) and 1 631 510 7495 (US)

Participant free phone dial-in: 0800 376 7922 (UK) and 1 866 966 1396 (US)

Conference ID: 7992149

For more information, please contact:

 
Vectura Group plc                                   [phone] 
David Ginivan - VP Corporate Communications 
 Julia Wilson - Director Investor Relations 
Consilium Strategic Communications                  [phone] 
Mary-Jane Elliott / Jessica Hodgson / David Daley 
 

About VR647

VR647 (US) is Vectura's wholly-owned specialist pipeline drug/device combination asset using the AKITA(R) JET innovative smart nebuliser technology. VR647 comprises Budesonide Inhalation Suspension, together with Vectura's novel proprietary VR647 Inhalation System, and is being positioned as an alternative treatment for asthma in children in the US market.

Market opportunity: despite generic entry, the nebulised budesonide market in the US remains a significant market opportunity with sales of approximately $760 million[i] in 2017 and stable volumes of >30m units[ii]. More than 50%[iii] of nebulised budesonide patients are 8 years old and under in the US. We believe VR647 will offer sufficient differentiation from existing nebulised budesonide therapies to support the premium versus generic pricing. As previously indicated, we continue to explore partnering options for VR647.

About Vectura

Vectura is an industry-leading inhaled product formulation, device design and development business offering a uniquely integrated inhaled drug delivery platform. We develop inhalation products to help patients suffering from airways diseases.

Vectura has eight key inhaled, two non-inhaled and ten oral products marketed by partners with growing global royalty streams, and a diverse partnered portfolio of drugs in clinical development. Our partners include Hikma, Novartis, Sandoz, Mundipharma, Kyorin, Baxter, GSK, UCB, Ablynx, Bayer, Chiesi, Almirall, Janssen, Dynavax and Tianjin KingYork.

Vectura's strategy is to fully leverage its differentiated technology and skills, maximising value by enhancing the delivery and performance of inhaled products and through the development of high-quality generic alternatives to branded therapies.

For further information, please visit Vectura's website at www.vectura.com.

[i] Source: IQVIA MIDAS data

[ii] Source: IQVIA MIDAS data

[iii] Source: IMS Health - Budesonide Market Sizing By Indication 2015

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August 21, 2018 02:00 ET (06:00 GMT)