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Sorry only just seen your post panic, yes you seem to be right about the UK. Have found Approval in Europe .

Thanks DC

Superb this is heading to 200p.

South Korean approval of AirFluSal Forspiro

RNS


RNS Number : 2046B

Vectura Group plc

28 February 2014






Vectura Group plc



South Korean Regulatory Authority confirm approval of AirFluSal® Forspiro®





Chippenham, UK - 28 February 2014: Vectura Group plc (LSE: VEC; "Vectura" or "the Company") confirms that our partner, Sandoz, has received South Korean marketing authorisation for AirFluSal® Forspiro® (formerly known as VR315), an innovative new inhaler for patients with asthma and chronic obstructive pulmonary disease (COPD), making it the first approval in Asia.

The product was first approved in Denmark on December 18th, 2013, with subsequent approvals in Germany, Belgium, Sweden, Norway, Hungary, Romania and Bulgaria and the product has now been launched in Denmark and Germany. The new product offers the proven combination of salmeterol (a long-acting inhaled β2-agonist) and fluticasone (an inhaled corticosteroid) in an innovative inhalation device.

· Visual control features which help reassure the patient about dosing

· Simple lever arm to load the dose

· Clear and accurate dose counter



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' 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. It is displayed in design museums in Essen and Singapore.

South Korea has approved the 50µg-250µg and 50µg-500µg dosage forms for the continuous treatment of patients above 12 years of age with persistent asthma or for symptomatic treatment of COPD.

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11 Mar N+1 Singer 159.00 Hold

Acquisition of Activaero

http://www.moneyam.com/action/news/showArticle?id=4771907
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13 Mar Canaccord... 150.00 Buy
13 Mar Finncap 180.00 Buy

SOLDOUT 160p

Vectura: JP Morgan ups target price from 200p to 230p maintaining its overweight rating.

VR315 US development milestone

RNS


RNS Number : 0635D

Vectura Group plc

25 March 2014






Vectura Group plc

VR315 US development milestone





Chippenham, UK - 25 March 2014: Vectura Group plc (LSE: VEC; "Vectura" or the "Company") announces that it has triggered a milestone 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. Vectura today announces that it will be recording a further development milestone under this agreement of $3m (£1.8m) in revenues. Vectura is eligible to receive up to a further $29m 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 VR315 US sales.



Dr. Chris Blackwell, Chief Executive of Vectura:

"This news illustrates the progress being made in the development of VR315 in the US. This milestone further de-risks our high value respiratory generic portfolio in the US, provides an important cash milestone to Vectura and is another step forward in the product's development."





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The smart nebuliser FOX wins Red Dot Design Award

RNS


RNS Number : 6607D

Vectura Group plc

01 April 2014








Vectura Group plc



The smart nebuliser FOX wins Red Dot Design Award





Chippenham, UK - 1 April 2014: Vectura Group plc (LSE: VEC; "Vectura" or the "Company") announces that the smart nebuliser device FOX has won the 2014 Red Dot Award for product design.

The award winning FOX inhaler is a smart and efficient handheld nebuliser for treatment of respiratory diseases. Its breathing control enables highly accurate drug delivery to the small airways.

The FOX inhalation system is a hand-held, self-contained, battery-powered, mesh nebuliser device with high performance using Activaero's* own vibrating mesh aerosol generator. The mesh-based aerosolisation engine used in FOX is proprietary to Activaero*, the rights having been in-licensed to Activaero* on an exclusive basis from a third party. The FOX inhalation system also makes use of a flow sensing/controlling valve system and is both re-chargeable and Bluetooth®-enabled. The latter feature allows for remote firmware updates without cable connection or for the system to upload patient use data for review by a healthcare professional.

The clear and user centric design of FOX make inhalation treatments potentially shorter in duration and more convenient.

Bernhard Müllinger, Chief Technical Officer at Vectura GmbH states "During the design process of FOX we undertook extensive market research to understand a device that patients use intuitively in the right way. Since most dose delivery errors associated with respiratory therapies are caused by inappropriate breathing patterns, we developed a LED lighting to prompt users to breathe correctly during dose administration. The device also features key-lock indicators for intuitive assembly of the components." FOX is fully battery powered and can be recharged with standard phone chargers with micro-USB connectors. Patients who use the FOX device can use the device at home, during work or while traveling.

Red Dot CEO and founder Dr. Peter Zec, notes, "Our experts assessed the quality of the entries with the utmost care and attention…But only the best products receive an award from the jury. This is especially reflected in the percentage of successful entries in the Red Dot Award, which is much smaller in contrast to other international design competitions. Therefore, the winners can be proud of their achievements - with their entries, they stood out from the rest and were able to pass the test in front of the critical eyes of the experts."

Design winners are celebrated during a presentation at the acclaimed Red Dot Gala on 7 July 2014. The award-winning products will be displayed in a special exhibition at the Red Dot Design Museum in Essen, Germany from 8 July to 3 August 2014.



* Vectura GmbH (formerly Activaero GmbH) is a wholly owned subsidiary of Vectura Group plc

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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."



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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.



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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.

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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."

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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."



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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."

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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."

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