Our portfolio comprises partnered and licenced marketed products as well as branded and generic investigational drugs. Each category has specific benefits in terms of revenue and IP accretion.

Our business model allows us to pursue various routes to market including partnership, co-development and self-commercialisation.

This shows a combined pipeline of Vectura and Skyepharma immediately following completion of the merger.


  • Branded key Branded
  • Generic key Generic
  • Biologic key Biologic
  • Partnered key Partnered
  • Wholly owned key Wholly owned

VR588 Severe Inflammatory Airways Disease

(Global)

VR588 is a broad-based, potent and selective pan-JAK inhibitor that demonstrates a pharmacokinetic profile suitable for development as an inhaled treatment. Pre-clinical development activities have progressed successfully and Phase I-enabling inhalation toxicology studies have commenced.

This product pipeline asset has the following key elements:

  • multiple indications are possible; and
  • investment and focus on activities that generate data to support licensing will be minimised.

SKP-2076 (Mundipharma)

Asthma

Soctec™

Gastro-retentive

Oleotec™

Gastro-retentive

SKP-1059

Abuse deterrent

VR475 (FAVOLIR®) Severe Uncontrolled Adult Asthma

(US)

VR475 is an inhaled, add-on therapy for the treatment of adult patients with severe, uncontrolled asthma with a history of exacerbations with or without dependence on oral corticosteroids. VR475 is a drug/device combination comprising “smart” delivery of nebulised budesonide, delivered with Vectura’s smart nebuliser system, the AKITA® JET, utilising Vectura’s FAVORITE™ technology.

This product pipeline asset has the following key elements:

  • developed to reduce exacerbations in severe uncontrolled asthmatics (GINA steps 4 and 5) with a history of exacerbations and/or dependence on oral corticosteroids;
  • aim to show greater efficacy than conventionally nebulised budesonide and to be more cost effective than mAbs;
  • programme endorsed by CHMP scientific advice procedure; and
  • development plan will be discussed with FDA post completion of the EU clinical study.

VR647 (SCIPE)

(US)

VR647 is a drug/device combination comprising “smart” delivery of nebulised budesonide for maintenance treatment of asthma in children for the US market, delivered with Vectura’s smart nebuliser system, the AKITA® JET nebuliser, utilising Vectura’s FAVORITE™ technology.

This product pipeline asset has the following key elements:

  • opportunity to introduce an improved product to an established US market;
  • developed to increase precision and reduce dosing time in children;
  • developed as a maintenance treatment for asthma for the paediatric label only (age range twelve months to eight years) with the objective to retain current label/indication for budesonide;
  • FDA agreed 505(b)(2) pathway for development programme;
  • anticipated IND filing in mid-2016; and
  • Phase III study to start mid-2018 with filing anticipated in mid-2020.

VR465 (Ablynx) Respiratory Syncytial Virus Infection

(Global)

The Belgian biotech company Ablynx is developing the anti-RSV Nanobody® ALX-0171 for the treatment of RSV infections in infants.

ALX-0171 is a Nanobody drug candidate, administered via inhalation, for the treatment of RSV infection in infants. VR465 is being developed by our partner Ablynx and utilises Vectura’s smart nebuliser technology device, the FOX®, to deliver the Nanobody to patients. The FOX® device used in this programme has been adapted for use with neonates and infants.

Ablynx confirmed in December 2015 that it has completed target enrolment of the first in-infant Phase I/IIa safety study with its wholly owned anti-RSV Nanobody®, ALX-0171.

Post the period end, on 2 May 2016, Ablynx reported positive top line results which they believe supports advancement into a Phase II efficacy study in infants.

VR942 (UCB) Uncontrolled Asthma

(Co-development global)

In September 2013, Vectura and UCB announced a collaboration for the development of an innovative inhaled biologic immunomodulatory product in the area of severe inflammatory respiratory disease.

The partnership, leveraging Vectura’s DPI/formulation and clinical/regulatory experience with UCB’s biologics and immunology expertise, will focus upon the development of VR942 to completion of Phase II clinical proof of concept.

In June 2015, following the successful completion of a number of pre-clinical studies, enrolment commenced into a Phase I clinical study in healthy volunteers and patients with asthma.

The selection of final Phase II clinical study design is anticipated in H1 2016.

SKP-1052

Nocturnal hypoglycemia

VR179 (Grifols) Cystic Fibrosis

(Global)

VR179 is a nebulised alpha-1 antitrypsin product, under investigation for the treatment of cystic fibrosis. The programme is partnered with the Spanish company Grifols.

VR736 (Ventaleon) Severe Influenza

(Global)

VR736 is an inhaled treatment, delivered by Vectura's smart nebuliser system, the AKITA® JET, for hospitalised patients with severe influenza, which is being developed by Ventaleon; Vectura has a minority stake with an investment syndicate.

VR096 (Janssen) Anti-inflammatory Asthma/COPD

(Global)

Global development and licence agreement with Janssen for the exclusive development of novel anti-inflammatory therapies for the treatment of asthma/COPD. Initial focus is on the development of a Phase II candidate with the possibility to include additional clinical-stage candidates.

Leveraging Vectura’s expertise and proprietary dry powder inhaler technologies for the development of inhaled therapeutics. Vectura will apply its delivery technologies to develop Janssen’s pulmonary products into late-stage clinical development and commercialisation.

The clinical development programmes is led by Janssen, with Vectura responsible for pharmaceutical development and manufacturing to support Phase II clinical trials and beyond.

VR475 (FAVOLIR®) Severe Uncontrolled Adult Asthma

(EU)

VR475 is an inhaled, add-on therapy for the treatment of adult patients with severe, uncontrolled asthma with a history of exacerbations with or without dependence on oral corticosteroids. VR475 is a drug/device combination comprising “smart” delivery of nebulised budesonide, delivered with Vectura’s smart nebuliser system, the AKITA® JET, utilising Vectura’s FAVORITE™ technology.

This product pipeline asset has the following key elements:

  • developed to reduce exacerbations in severe uncontrolled asthmatics (GINA steps 4 and 5) with a history of exacerbations and/or dependence on oral corticosteroids;
  • aims to show greater efficacy than conventionally nebulised budesonide and to be more cost effective than mAbs;
  • a programme endorsed by CHMP scientific advice procedure;
  • Phase III results anticipated in mid-2018; and
  • patient recruitment underway.

VR876 (partner undisclosed) Serious Lung Disease

(EU)

This is being developed by an undisclosed partner as a nebulised version of a currently marketed drug for the treatment of serious lung disease. It uses Vectura’s smart nebuliser technology to improve the patient acceptance of the product. Regulatory action is expected in 2016 and subsequent commercialisation if approved.

QVM149 (Novartis) Asthma

(EU, RoW)

QVM149 is a fixed dose, once-daily combination of the LABA indacaterol, the LAMA glycopyrronium bromide and the ICS mometasone furoate.

First regulatory filings of QVM149 are planned for 2018.

Glycopyrronium bromide was licenced exclusively to Novartis in April 2005 by Vectura and its co-development partner Sosei.

Under the terms of the agreement with Novartis, Vectura is eligible to receive development, filing and approval milestones.

flutiform (mundipharma)

COPD (Asia)
Asthma (China)

VR315 (Hikma) Asthma/COPD

(US)

VR315 is the generic version of GSK’s Advair® Diskus®, which is indicated for the treatment of asthma and the maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) and is delivered using Vectura’s proprietary dry powder inhaler and formulation technology. In August 2011, Vectura signed a licence agreement for the development, manufacturing and commercialisation of VR315 in the US with Roxane Laboratories, Inc., a subsidiary of Boehringer Ingelheim Corporation(1).

  • Vectura will receive an US$11m payment on approval of file; and
  • Vectura will receive a royalty from sales of VR315 in the US.
  • Post period 8 April 2016, Hikma confirmed that the ANDA had been accepted for filing by the FDA. The FDA has provided Hikma with a GDUFA goal date of 10 May 2017.

(1) Hikma completed the acquisition of Roxane Laboratories, Inc. from Boehringer Ingelheim Corporation in February 2016.

VR506 (Hikma) Asthma

(US)

VR506 is an inhaled corticosteroid for the treatment of asthma, which entered clinical development in 2011. In June 2014, Vectura signed a partnership agreement in the US with Roxane Laboratories, Inc., a subsidiary of Boehringer Ingelheim Corporation and is the same partner as the VR315 programme.

Under the terms of this partnership agreement, Vectura’s partner is responsible for the commercialisation and manufacture of the product together with clinical development. Vectura has received an initial payment of US$4.0m and is eligible to receive up to US$8.0m upon achievement of future pre-determined milestones. In addition, Vectura will receive a royalty from all VR506 US sales.

VR632 (Sandoz) Asthma/COPD

(EU)

VR632 is a generic, inhaled combination therapy for asthma and COPD delivered using Vectura’s proprietary dry powder inhaler and formulation technology.

In December 2007, Vectura signed a licence agreement with Sandoz for the development, manufacturing and commercialisation of VR632 in Europe. To date, Vectura has announced receipt of development milestones under the agreement of €1.75m.

SKP-1056 (Hikma)

Undisclosed

Utibron™ Neohaler® (Novartis) COPD

(US)

Utibron™ Neohaler® was approved in October 2015 as a twice-daily dual combination of indacaterol and glycopyrrolate in the US for the long-term maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. Novartis has indicated this product should be available in the US in 2016. Once launched, the product will bring a new royalty stream for Vectura.

Seebri™ Neohaler® (Novartis) COPD

(US)

Seebri™ Neohaler® was approved in the US in October 2015 as a twice-daily standalone monotherapy for the long-term maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. Novartis has indicated this product should be available in the US in 2016. Once launched, the product will bring a new royalty stream for Vectura.

Utibron™ and Seebri™ are trademarks of Novartis AG. Neohaler® is a registered trademark of Novartis AG.

flutiform®
Breath-actuated (Mundipharma)

Asthma (EU)

1 Bridging study to enable Phase III