Powered by IST's

FAVOLIR Regulatory Update

RNS


RNS Number : 5869E

Vectura Group plc

11 April 2014








Vectura Group plc

FAVOLIR Regulatory Update





Chippenham, UK - 11 April 2014: Vectura Group plc (LSE: VEC; "Vectura" or the "Company") announces that it will initiate a pivotal study in Europe later this calendar year for FAVOLIR, its investigational product for severe, uncontrolled asthma.



This decision underlines the Company's planned strategy for a broad European development programme for FAVOLIR, rather than a country-specific approach, and this decision follows a recent meeting with the German regulator (BfArM) regarding the local development options for the product.



Dr. Chris Blackwell, Chief Executive of Vectura:



"The feedback that we received from BfArM is in-line with our own expectations. The constructive dialogue that we have had with the BfArM has helped us in our planning for the upcoming European pivotal trial and we look forward to taking the development of FAVOLIR to the next stage. FAVOLIR is an important product and is of potentially high value to all stakeholders."



-Ends-

GSK milestone

RNS


RNS Number : 7748F

Vectura Group plc

29 April 2014






Vectura Group plc



GSK milestone





Chippenham, UK - 29 April 2014: Vectura Group plc (LSE: VEC; "Vectura" or "the Company") announces that it has triggered a £2m milestone associated with its licence and option to license agreement with GSK following the launch of ANORO™ ELLIPTA™ in the US.

In August 2010, GSK entered into a licence and an option to license agreement for certain of Vectura's dry powder formulation patents. Under the terms of the licence and option to license agreement, Vectura received an up-front payment of £10m in September 2010 and was due to receive a further £10m in milestones. All £10m of these milestones have now been triggered.



-Ends-

Coming back now.

Ultibro Breezhaler superior efficacy vs Seretide

RNS


RNS Number : 8480F

Vectura Group plc

30 April 2014








Vectura Group plc

Ultibro® Breezhaler® showed superior efficacy versus Seretide®* for COPD patients in second head-to-head study, and the anticipated timing of China filing



· Ultibro® Breezhaler® demonstrated superiority in lung function compared to Seretide® Accuhaler®* in chronic obstructive pulmonary disease (COPD) patients with or without exacerbations in the previous year



· Primary and key secondary objectives met in pivotal Phase III LANTERN study



· Positive results to be part of the regulatory submission for Ultibro Breezhaler in China later this year



Chippenham, UK - 30 April 2014: Vectura Group plc (LSE: VEC) ("Vectura"), confirms the information released today by Novartis announcing positive first results from the Phase III head-to-head LANTERN study, which showed the superiority of once-daily Ultibro® Breezhaler® (indacaterol/glycopyrronium) 110/50 mcg in improving lung function compared to twice-daily Seretide® Accuhaler®* (salmeterol/fluticasone (SFC)) 50/500 mcg in COPD patients with or without a history of moderate-to-severe exacerbations in the previous year. Ultibro Breezhaler met both the primary and key secondary objectives.

The primary objective of the LANTERN study was to demonstrate the non-inferiority of Ultibro Breezhaler to SFC in terms of lung function (trough FEV1) after 26 weeks of treatment in patients with moderate-to-severe COPD, with or without a history of moderate-to-severe exacerbations in the previous year. Ultibro Breezhaler demonstrated non-inferiority and additionally showed superior efficacy versus SFC for the primary objective. These results will be part of the regulatory submission of Ultibro Breezhaler in China later this year.

The LANTERN study also showed superiority of Ultibro Breezhaler compared to SFC for the key secondary objective of lung function (FEV1 AUC0-4h) over the first four hours post dose at week 26. The safety and tolerability profile of Ultibro Breezhaler was comparable to SFC.

COPD is a major public health concern in China, ranking first in terms of the country's disease burden1. Recent estimates suggest that in China over 40 million people have COPD2 and the overall prevalence in people aged 40 years or older is 8%1.

COPD symptoms can have a major, negative impact on a patient's ability to breathe and function and they reduce their quality of life3. Essential daily activities such as climbing stairs can become very difficult as the condition gradually worsens4. There is a need for new treatment options in COPD because many patients remain symptomatic despite medical therapy5.

-Ends-


------------------------------------------------------------------------------------------

30 Apr Finncap 202.00 Buy

Final Results

RNS


RNS Number : 6587H

Vectura Group plc

21 May 2014






Vectura Group plc - Preliminary Results



Strong financial performance; significant progress on respiratory programmes; breakthrough for generic respiratory products; pipeline augmented



Chippenham, UK - 21 May 2014: Vectura Group plc (LSE: VEC) ("Vectura"), which specialises in the development of products for the treatment of airway-related diseases, announces today its preliminary results for the year ended 31 March 2014.

Financial Highlights

Strong financial performance

· Revenues up 20% at £36.5m (2012/13: £30.5m)

· Positive EBITDA1 of £5.2m (2012/13: loss of £3.4m)

· Loss before tax decreased by 54% to £4.8m (2012/13: £10.4m)

· Balance sheet strength maintained with cash and cash equivalents of £81.7m (£70.1m at 31 March 2013)



Operational Highlights

Significant progress on respiratory programmes

· Seebri® Breezhaler® (glycopyrronium bromide, NVA237) approved in over 60 countries, including EU, Japan, Canada and Australia

o Q1 2014 net sales of $30m; 12 months to 31 March 2014 of $82m (Source: Novartis)

· Ultibro® Breezhaler® (indacaterol/glycopyrronium bromide, QVA149) launched in seven countries to date and approved in over 30, including EU, Japan, Canada and Australia

o Q1 2014 net sales of $14m; total of $20m since launch (Source: Novartis)

· Approvals of GSK's BREO™ ELLIPTA™ and ANORO™ ELLIPTA™ signalled new royalty streams



Breakthrough for generic respiratory products

· AirFluSal® Forspiro® (VR315) approved in Denmark, Germany, Belgium, Sweden, Hungary, Romania, Norway, Bulgaria and South Korea; product now launched in most of these markets

· VR315 development in the US continues to make progress; additional milestone received

· FDA guidelines were a positive step for development of inhaled generics in the US



Pipeline augmented

· Acquisition of Activaero GmbH strengthens development pipeline and enhances technology offering

· Initiated co-development deal with UCB for a novel molecule (VR942) currently at the pre-clinical stage

· The establishment of Kinnovata JV formed in China; extracting additional value from our mature assets. Kinnovata joint venture is still awaiting formal completion. Final local Government approval expected later in 2014, upon which an exceptional non-cash gain will be recognised.



Other highlights

· Placing completed 13 March 2014 and raised gross proceeds of £52m

· Two changes to the Board during the year:

o Jack Cashman retired as Non-executive Chairman of the Board and Bruno Angelici was appointed as Non-executive Chairman in February 2014

o July 2013, Anne Hyland stepped down as Chief Financial Officer and Company Secretary and Paul Oliver was appointed Chief Financial Officer and Company Secretary



Post-period event

· US launch of ANORO™ ELLIPTA™ triggered a £2m milestone associated with a licence agreement with GSK



Dr Chris Blackwell, Chief Executive of Vectura:

"The past year has been very significant for Vectura, driven by the tremendous progress made from the approvals and commercialisation of partnered assets and in the acquisition of Activaero. Looking ahead, we anticipate the continued commercialisation of Seebri® Breezhaler®, Ultibro® Breezhaler® and AirFluSal® Forspiro®, which will augment our growing royalty streams. We are determined to create further value in our Company and believe we are well-placed with our strategy to build a specialty pharmaceutical company focussed on airways-related diseases."

- Ends -

Vectura Group: Berenberg moves target price from 200p to 210p and keeps a buy recommendation.

VR315 US development milestone

RNS


RNS Number : 3206K

Vectura Group plc

24 June 2014






Vectura Group plc

VR315 US development milestone





Chippenham, UK - 24 June 2014: Vectura Group plc (LSE: VEC; "Vectura" or the "Company") announces that it has triggered a milestone of $1.5 million associated with the development of VR315 in the US.

In August 2011, Vectura signed a licence agreement for the development, manufacturing and commercialisation of VR315 in the US with the US division of a leading international pharmaceutical company. To date, Vectura has announced development milestones under this agreement totaling $6m. Vectura announces today that it will be recording a further development milestone under this agreement of $1.5m. Vectura is eligible to receive a further $27.5m upon achievement of future pre-determined development milestones. These milestones, together with the initial payment of $10m in August 2011, total $45m. In addition, Vectura will receive a royalty from all sales of VR315 in the US.

Dr. Chris Blackwell, Chief Executive of Vectura:

"This announcement illustrates the continued progress being made in the development of VR315, a major part of our high value respiratory generic portfolio in the US, and provides another cash milestone to Vectura."



-Ends-

US collaboration agreement for VR506

RNS


RNS Number : 8372K

Vectura Group plc

30 June 2014






Vectura Group plc

Vectura announces a further US collaboration agreement with a leading international pharmaceutical company for the VR506 asthma therapy





Chippenham, UK - 30 June 2014: Vectura Group plc (LSE: VEC; "Vectura" or the "Company") announces that it has signed a US collaboration, development and license agreement for VR506, Vectura's clinical stage asthma monotherapy delivered using Vectura's proprietary technology. The agreement for VR506 is with Vectura's existing, undisclosed, US partner for VR315 (a combination therapy for asthma/COPD).

Under the terms of this agreement, Vectura's partner will be responsible for the commercialisation and manufacture of the product together with clinical development. Vectura will provide support for the US development of VR506, for which it will receive an initial payment of $4 million and up to $8million upon achievement of pre-determined development milestones. Further development fees may be payable to Vectura if the program progresses beyond a pre-defined milestone. In addition, Vectura will receive a royalty from all VR506 US sales.

Dr. Chris Blackwell, Chief Executive of Vectura:

"This is an important step for the development of VR506 for the potentially lucrative US market and it extends the successful collaboration with our established US partner. This provides additional third party validation of the progress we have made to date and is a major endorsement of the potential value of this product."

-Ends-

1 Jul Canaccord... 192.00 Buy

Interim Management Statement

RNS


RNS Number : 4399P

Vectura Group plc

19 August 2014






Vectura Group plc



Interim Management Statement



Chippenham, UK - 19 August 2014:Vectura Group plc (LSE: VEC; "Vectura" or the Company), today publishes its Interim Management Statement for the period 1 April 2014 to 19 August 2014.



Following the acquisition of Activaero GmbH in March 2014, the integration of the business is progressing well and Vectura's product pipeline is progressing in line with the Board's expectations.



VR506 (asthma) deal signed

On 30 June 2014, we reported that we had signed a development and license agreement for the US rights to VR506, Vectura's clinical stage asthma monotherapy product delivered using Vectura's proprietary technology. The agreement for VR506 is with Vectura's existing, undisclosed US partner for VR315 (a combination therapy for asthma/COPD). Under the terms of this agreement, Vectura's partner will be responsible for the commercialisation and manufacture of the product together with clinical development. Vectura will provide support for the US development of VR506, for which it will receive an initial payment of $4 million and up to $8 million upon achievement of pre-determined development milestones. Further development fees may be payable to Vectura if the programme progresses beyond a pre-defined milestone. In addition, Vectura will receive a royalty from all VR506 US sales.



Continued progress of US VR315 generic programme (asthma/COPD)

On 24 June 2014, we announced that we had triggered a $1.5m milestone associated with the development of VR315 in the US.



Seebri® Breezhaler® (NVA237) and Ultibro® Breezhaler® (QVA149)

The roll-out of Seebri® Breezhaler® and Ultibro® Breezhaler® continues, with Novartis reporting sales of $67m and $36m respectively for the first two quarters of the 2014 calendar year.



Novartis expect the US filing of NVA237 and QVA149 to occur in Q4 2014.



GSK licence

On 29 April 2014, we announced we had triggered the final £2m milestone relating to the licence agreement that was signed with GSK in August 2010. Under this agreement, Vectura also receives royalties on sales of BREO®/Relvar® ELLIPTA® and ANORO® ELLIPTA® up to a cap of £13m per annum. During the first two quarters of the 2014 calendar year, GSK reported sales of £11m for BREO®/Relvar® ELLIPTA® and £5m for ANORO® ELLIPTA®.



Financial update

On 21 May 2014, Vectura announced its full year results for the year ended 31 March 2014 and confirmed its robust financial position, with a cash balance of £81.7m at that date and reported a positive EBITDA of £5.2m (FY 2012/13 - loss of £3.4m).



Vectura's financial performance from 1 April 2014 to date has been in line with the Board's expectations.



Vectura's interim results for the six month period to 30 September 2014 will be announced on 18 November 2014.



Dr Chris Blackwell, Chief Executive of Vectura, commented:



"During the period we have made excellent progress with our generic programmes and we now have the support of our existing partner for VR315 in the US to help us bring VR506 to the market in an expeditious manner. With our strong cash balance and our new royalty revenues, along with the royalties received from the excellent progress of Seebri® Breezhaler® and Ultibro® Breezhaler®, Vectura is well positioned to continue its transition towards creating a leading specialty pharmaceutical company focused on airways disease."

-Ends-

First approval in Latin America for AirFluSal

RNS


RNS Number : 6769P

Vectura Group plc

21 August 2014






Vectura Group plc



First approval in Latin America for innovative respiratory inhaler AirFluSal® Forspiro®



· Mexico's Health Authority (COFEPRIS) grants marketing authorisation for AirFluSal® Forspiro®

· Approval for 50-100 mg, 50-250 mg and 50-500 mg dosage forms

· Product to be branded IrFlosol™ Forspiro® in Mexico

· Airflusal® Forspiro® already launched in four European countries as well as in South Korea



Chippenham, UK - 21 August 2014: Vectura Group plc (LSE: VEC; "Vectura" or "the Company") confirms that our partner Sandoz, has been granted marketing authorisation by the Mexican Health Authority (COFEPRIS) for AirFlusal® Forspiro®, an innovative new inhaler for patients with asthma and/or chronic obstructive pulmonary disease (COPD).



The approval in Mexico is the first in Latin America and follows the marketing authorisations in a total of eight European countries as well as in South Korea. Four European countries have already launched AirFluSal® Forspiro® in addition to the launch in May 2014 in South Korea.



Mexico has approved Airflusal® Forspiro® in the 50-100 µg, 50-250 µg and 50-500 µg dosage forms and the product will be branded IrFlosol™ Forspiro®.



AirFluSal® Forspiro® offers the proven combination of salmeterol (a long-acting inhaled β2-agonist) and fluticasone propionate (an inhaled corticosteroid) in an innovative new device. The product's safety, efficacy and equivalence have been proven in multiple clinical trials. Vectura initially developed the VR315 product and created the design of the innovative inhaler, before licensing the asset to Sandoz in 2006. It was subsequently developed in collaboration with Vectura as AirFluSal® Forspiro® by Aeropharm GmbH in Rudolstadt, Germany, Sandoz's global respiratory Center of Excellence. The innovative and intuitive-to-use design of the inhaler was awarded the Red Dot Product Design award in 2011, an internationally recognised quality seal awarded by the Design Zentrum Nordrhein Westfalen in Essen, Germany.





-Ends-

Presentation at ERS

RNS


RNS Number : 9111Q

Vectura Group plc

05 September 2014






Vectura Group plc



Presentation at ERS





Chippenham, UK - 5 September 2014: Vectura Group plc (LSE: VEC; "Vectura" or "the Company"), advises that the following presentation will be made at 8:30am CEST, 9 September at the European Respiratory Society (ERS) International Congress 2014, being held in Munich, Germany, 6-10 September 2014.



Vectura will present data at the European Respiratory Society International Congress 2014

Effectively targeting small airways using controlled inhalation for peripheral corticosteroid deposition

Data to be presented at ERS by Vectura will include:



Lung function data (FEV1 and FEF25-75) from a clinical study in oral corticosteroid dependent asthma patients (GINA V) using the AKITA Jet inhalation system with FAVORITE technology to deliver Budesonide to the small airways as add on therapy.



It shows that lung function did significantly improve under therapy.



The abstract will be presented by Dr. Sebastian Canisius in a Poster Discussion Session: Novel approaches and evidence for drug development in respiratory diseases on Tuesday, 9 September, 8:30am - 10:30am CEST, Room M-1 (B0), Session 365.

Approval in Baltics for AirFluSal Forspiro

RNS


RNS Number : 0432W

Vectura Group plc

04 November 2014






Vectura Group plc



Approval in Baltics for innovative respiratory inhaler AirFluSal® Forspiro®



· Regulatory authorities in Estonia, Latvia and Lithuania grant marketing authorisations for AirFluSal® Forspiro®

· Approval for 50-250 and 50-500 µg dosage forms

· AirFluSal® Forspiro® already launched in four European countries and South Korea





Chippenham, UK - 4 November 2014: Vectura Group plc (LSE: VEC; "Vectura" or the "Company") confirms that our partner Sandoz, has been granted marketing authorisation by the pharmaceutical regulatory authorities in Estonia, Latvia and Lithuania for AirFluSal® Forspiro®, an innovative new inhaler for patients with asthma and/or chronic obstructive pulmonary disease (COPD).

These latest marketing authorisations by the three Baltic states, which are members of the European Union (EU), mean that AirFluSal® Forspiro® has now been approved in a total of 13 European countries, as well as South Korea and Mexico. The product has been launched in five countries to date, including South Korea.

The three Baltic states all approved AirFluSal® Forspiro® in the 50-250 and 50-500 µg dosage forms.

AirFluSal® Forspiro® offers the proven combination of salmeterol (a long-acting inhaled beta-2 agonist) and fluticasone propionate (an inhaled corticosteroid) in an innovative new device. The product's safety, efficacy and equivalence have been proven in multiple clinical trials.

Vectura initially developed the VR315 product and created the design of the innovative inhaler, before licensing the asset to Sandoz in 2006. It was subsequently developed in collaboration with Vectura as AirFluSal® Forspiro® by Aeropharm GmbH in Rudolstadt, Germany, Sandoz's global respiratory Center of Excellence. The innovative and intuitive-to-use design of the inhaler was awarded the Red Dot Product Design award in 2011, an internationally recognised quality seal awarded by the Design Zentrum Nordrhein Westfalen in Essen, Germany.

The device includes multiple feedback mechanisms such as visual control features, which help reassure the patient about dosing, a simple lever arm to load the dose, and clear and accurate feedback on remaining available doses.

-Ends-

VR315 US development milestone

RNS


RNS Number : 4109W

Vectura Group plc

07 November 2014






Vectura Group plc

VR315 US development milestone





Chippenham, UK - 7 November 2014: Vectura Group plc (LSE: VEC; "Vectura" or the "Company") announces that it has triggered a further milestone associated with the development of VR315 in the US. VR315 is a combination therapy for asthma/COPD delivered using Vectura's proprietary technology.



In August 2011, Vectura signed a licence agreement with the US division of a leading international pharmaceutical company for the development, manufacturing and commercialisation of VR315 in the US.



To date, Vectura has announced development milestones under this agreement totalling $7.5m. The milestone announced today is an additional $1.5m.



Vectura is eligible to receive a further $26m upon achievement of future pre-determined development milestones. These milestones, together with the initial payment of $10m in August 2011, total $45m. In addition, Vectura will receive a royalty from all sales of VR315 in the US.



Dr. Chris Blackwell, Chief Executive of Vectura:

"This announcement of a further development milestone in 2014 continues to demonstrate the progress being made on the VR315 US development and forms a major part of our high value respiratory generic portfolio in the US."

-Ends-

14 Nov Canaccord... 192.00 Buy
12 Nov Canaccord... 192.00 Buy
7 Nov finnCap 202.00 Buy
6 Nov JP Morgan... N/A Overweight
4 Nov finnCap 202.00 Buy

Half Yearly Report

RNS


RNS Number : 2666X

Vectura Group plc

18 November 2014






Vectura Group plc



- Strong interim results driven by 45% increase in royalties -



- Portfolio review complete -



Chippenham, UK - 18 November 2014: Vectura Group plc (LSE: VEC) ("Vectura"), which specialises in the development of products for the treatment of airways diseases, today announces its unaudited interim results for the six months ended 30 September 2014.



Financial Highlights

· Revenues up 14% to £19.4m (H1 2013/14: £17.0m; FY 2013/14: £36.5m)

· EBITDA1 up 30% to £3.0m (H1 2013/14: £2.3m; FY 2013/14: £5.2m)

· Loss before tax of £7.1m (H1 2013/14: loss £1.2m; FY 2013/14: loss £4.8m) due to increased amortisation charge relating to acquisition

· Adjusted basic EPS2 of 0.8p (H1 2013/14: 0.7p; FY 2013/14: 1.6p)

· Robust balance sheet with cash and cash equivalents of £84.6m (£81.7m at 31 March 2014)



Operational Highlights



Activaero

· Integration on track

· Increased level of deal opportunities since the acquisition



VR315 US (asthma/COPD)

· Milestone payment of $1.5m associated with positive development of VR315 in the US

o Post period: Further development milestone of $1.5m recognised (November 2014)



VR506 (asthma) licence agreement signed

· Signed a US licence agreement with Vectura's existing, undisclosed US partner (for VR315)

o Important step in the development of VR506 for the US market

o Extends the successful collaboration with our established US partner



Global roll-out of inhaled assets by partners increases royalty revenues by 45%

· Seebri® Breezhaler®*(glycopyrronium bromide, NVA237) - approved in over 70 countries across Europe, Japan, Canada, Latin America, Asia, Australia and the Middle East

o Q2/Q3 2014 total net sales of $74m (Source: Novartis)3

o NVA237 is expected to be filed in the US by Novartis in Q4 2014



· Ultibro® Breezhaler®*(indacaterol/glycopyrronium bromide, QVA149) - approved in over 40 countries outside the US (including EU, Japan, Canada, Mexico, Australia and Switzerland) and launched in 21 countries (including Germany, Japan and Canada)

o Q2/Q3 2014 total net sales of $53m (Source: Novartis)3

o QVA149 is expected to be filed in the US by Novartis in Q4 2014



· AirFluSal® Forspiro®*approved in a total of 13 European countries, as well as South Korea and Mexico. Launched in five countries to date.

o Post period: Marketing authorisation granted in Portugal, triggering a €1.5m milestone (October 2014), and in three Baltic states; Estonia, Latvia and Lithuania



* Ultibro®, Seebri®, Breezhaler®, AirFluSal® and Forspiro® are registered trademarks of Novartis AG



Portfolio review completed

· Projects prioritised and resources aligned with strategy



Dr. Chris Blackwell, Chief Executive of Vectura:



"In the first half of the FY2014/15, Vectura has delivered robust results with a 45% increase in royalties as its partnered products continue their global roll-out. We aim to continue to create value through the development and commercialisation of innovative products for airways diseases with high unmet need. Our focus is to optimise and accelerate return on investment. To this end, we have evaluated the strategic perspectives of our business through a thorough evaluation of our development portfolio, focusing on maintaining alignment with the evolution of our business model.



Vectura has become an established expert and 'partner of choice' in airways diseases product development.Our technology platform and pipeline has been improved by M&A and selective investment. We have seen a significant increase in business development opportunities following the acquisition of Activaero.



We now have a strong platform to take Vectura to the next level of its journey to become a specialty pharmaceutical company. This transition of our business model will be undertaken in conjunction with a disciplined prioritised investment in R&D and business development and we will continue to carefully assess M&A opportunities and focus on accretive, revenue-enhancing deals. Our near-term priorities to becoming a specialty pharma company are to accelerate the overall value of our existing pipeline and to demonstrate its value realisation.



Future new product launches will increase our royalty revenues further, allowing the Board to balance investment in growth and delivery of value to shareholders."



- Ends -

24 Nov Oriel... 207.00 Buy
24 Nov Barclays... 180.00 Overweight

Naked Trader - And I have bought more of Vectura (LON:VEC) where I now have a very big stake. The shares are starting to re-rate again after its half-year report last week. There's a good chance this one could end up being a massive company.

It's picked up a milestone payment after its astma inhaler's newest approvals. A long-term tuckaway which could bring massive rewards with a little patience.

7 Jan Canaccord... 192.00 Buy
6 Jan Oriel... 207.00 Buy
6 Jan finnCap 202.00 Buy
5 Jan JP Morgan... 230.00 Overweight
2 Jan finnCap 202.00 Buy

US submission for NVA237 and QVA149
RNS
RNS Number : 5943B
Vectura Group plc
08 January 2015



Vectura Group plc



Submission of regulatory applications to US FDA and robust Phase III results for QVA149 and NVA237



· Submissions to US FDA completed for QVA149 and NVA237 in Q4 2014



· Pivotal Phase III results for QVA149 and NVA237 met their primary endpoints and significantly improved lung function in COPD patients1-5



· US trials for QVA149 demonstrated significant improvements in overall health status compared to placebo1,2





Chippenham, UK - 8 January 2015: Vectura Group plc (LSE: VEC; "Vectura" or "the Company"), confirms the information released today by our partner Novartis announcing that the New Drug Applications (NDAs) for QVA149 and NVA237 for the long-term maintenance treatment of chronic obstructive pulmonary disease (COPD) were submitted to the US Food and Drug Administration (FDA) by Novartis in Q4 2014. Vectura is eligible to receive milestone payments upon the acceptance of applications by the US FDA.



In addition, positive top-line results were announced today by Novartis from the pivotal Phase III clinical trial programmes for QVA149 (indacaterol/glycopyrronium bromide) and NVA237 (glycopyrronium bromide) to support the application. The results from the EXPEDITION (including FLIGHT 1, 2 and 3 studies) and GEM (including GEM 1, 2 and 3 studies) clinical trial programmes met their primary and secondary endpoints.



The FLIGHT 1 and 2 studies met their primary objectives with twice-daily QVA149 demonstrating statistically significant and clinically meaningful improvements in lung function (FEV1 AUC0-12) at Week 12, compared to indacaterol and glycopyrronium bromide in moderate-to-severe COPD patients1,2,9. Improvements in overall health status, a secondary endpoint based on the St George's Respiratory Questionnaire (SGRQ) total score, and rescue medication usage were also seen with QVA149 compared to placebo at Week 121,2. The common adverse events reported for QVA149 were comparable to the individual components and placebo across the EXPEDITION studies1,2.



In the GEM 1 and 2 studies, twice-daily NVA237 demonstrated significant and clinically meaningful improvements in lung function (FEV1 AUC0-12h) at Week 12 in moderate-to-severe COPD patients compared to placebo; meeting its primary objective4,5,9. An improvement in health status was also observed in patients at Week 12. The adverse events reported for NVA237 were comparable to placebo across the GEM studies4,5.



Data from the EXPEDITION and GEM programmes are expected to be presented at major medical congresses later this year.



COPD symptoms can have a major negative impact on a patient's ability to breathe and perform essential daily activities, thereby reducing their quality of life6,7. There is an urgent need for new treatment options in COPD because many patients remain symptomatic despite medical therapy8.





About EXPEDITION

The EXPEDITION Programme consisted of studies, including FLIGHT 1 and 2, which were identical 12-week, multi-centre, randomised, double blind, parallel-group, placebo and active controlled studies to assess the efficacy, safety, and tolerability of QVA149 (indacaterol/glycopyrronium bromide) in moderate-to-severe COPD patients. The primary objective was to compare twice-daily QVA149 27.5/12.5 mcg to its monotherapy components in terms of lung function (FEV1 AUC0-12h) at Week 121,2.



FLIGHT 3 was a 52-week randomised double blind, parallel-group study to assess the safety and tolerability of twice-daily QVA149 27.5/12.5 mcg compared to once-daily indacaterol 75 mcg in moderate-to-severe COPD patients. The primary endpoint was the overall rate of adverse events reported during the study3.



About GEM

GEM 1 and 2 were 12-week multi-centre, randomised, double-blind, placebo controlled studies to assess the efficacy and safety of twice-daily NVA237 (glycopyrronium bromide) 12.5 mcg in moderate- to-severe COPD patients. The primary objective was to compare twice-daily NVA237 to placebo in terms of lung function (FEV1 AUC0-12h) after 12 weeks of treatment4,5. The objective of GEM 3 was to determine safety and tolerability of twice-daily NVA237 12.5 mcg compared to once-daily indacaterol 75 mcg in moderate-to-severe COPD patients.



About QVA149

Twice-daily QVA149 (indacaterol/glycopyrronium bromide) 27.5/12.5 mcg, as used in the EXPEDITION programme, is being submitted for US registration only. Outside of the US, QVA149 has been developed/marketed as Ultibro® Breezhaler® 110/50 mcg, which is a once-daily maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD10. Once-daily Ultibro® Breezhaler® is currently approved for use in over 50 countries, including countries within the EU and Latin America, Japan, Canada, Switzerland and Australia.



About NVA237

Twice-daily NVA237 (glycopyrronium bromide) 12.5 mcg, as used in the GEM trials, is being submitted for US registration only. Outside of the US, NVA237 has been developed/marketed as Seebri® Breezhaler® 50 mcg, which is a once daily medication indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD and is approved for use in over 70 countries, including countries within the EU and Latin America, Japan, Canada, Switzerland and Australia11. Glycopyrronium bromide was exclusively licensed to Novartis in April 2005 by Vectura and its co-development partner Sosei.



Ultibro®, Seebri® and Breezhaler® are registered trademarks of Novartis AG.



About COPD

COPD is associated with chronic morbidity and mortality and The World Health Organisation (WHO) estimates that 210 million people worldwide have COPD12. Deaths from COPD are projected to increase over the next 10 years by more than 30% unless underlying risk factors are addressed13. COPD is the third leading cause of death in America, claiming the lives of 134,676 Americans in 201014 and COPD is now the third leading cause of death worldwide15.



COPD is progressive (usually gets worse over time), and can be a life-threatening disease7,12. It makes it difficult to breathe, with symptoms that have a destructive impact on patients' function (i.e. activity limitation, decreased mobility) and quality of life7,14. It is often considered to be a disease of later years, but estimates suggest that 50% of those with COPD are now less than 65 years old, resulting in increases in absenteeism, premature retirement and reductions in workforce participation16,17.