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Vectura has an innovative and broad clinical pipeline that combines mid- and late-stage programmes with earlier-stage opportunities addressing large and fast-growing market sectors.

The respiratory pipeline comprises inhaled formulations of both branded and generic products for the treatment of asthma, chronic obstructive pulmonary disease (COPD) and cystic fibrosis (CF).

In the neurological area, Vectura is exploiting its pulmonary delivery technology for indications such as Parkinsons disease and migraine, and is exploring additional opportunities for future development.

For other indications, Vectura has invested in the development of products for sexual dysfunction and diabetes. Whilst these are not areas of in-house development focus for Vectura, they present significant licensing opportunities.

BOO

SET TO GO

LONDON (Thomson Financial) - Vectura Group PLC said its chief executive officer CP Blackwell and chief financial officer AP Hyland lifted their stake in the company to 0.03 pct and 0.04 pct respectively after they bought its 50,000 shares each through an exercise of options at 61 pence per share.

The company also said its two non-executive directors JR Brown and AJM Richards increased their stake in the company to 0.02 pct and 0.04 pct respectively after they bought the same number of shares through an exercise of options at the same price.

Just bought an interest at 46.22p per share today. I successfully traded these before, having bought innovata shares before being taken over a year ago. I sold at 92p and have watch them fall on the general lack of interest in small phamas. This fall may have been exaggerated. Apparantly, Co. broker, Piper Jaffray estimates VEC will have net cash of around 75,000,000 or about 23p per share by end of March 2008 and values Co's 8 pulmonary and non-pulmonary marketed products at 56p per share. Presumably, therefore,its 8 late stage developments etc are not attributed a value by the market. Of course there are the development risks of failure but the Co. does spread its risks. It is interesting that Fidelity has recently increased its stake to 5% and other notified holders have been Aviva, Amvescap and Legal and General. Aggregate Directors holdings are 430,000 shares.

sp up firmly today at 47p having dropped below 38p recently.

moving up in a weak market sp 51.25p

Vectura Group Plc. announced positive data from an early proof of concept study of VR147, a product in development for the symptomatic treatment of migraine.

With the compelling data completed earlier, the company said it will assess licensing options both for VR147 and for the use of its inhalation technology for the delivery of other triptans.

VR147 is an orally inhaled triptan therapy with the potential to provide enhanced benefits to migraine patients through its rapid onset of action, the pulmonary product development company said.

The triptan market currently dominates migraine therapy, with sales in excess of $2.3 billion in 2007

Vectra continues its recovery and is up over 20% over the past week. It is working with a Novartis subsidiary on a version of blockbuster asthma drugs. It is hoped that a cut price alternative to GSK's Advair and AstraZ's Symbicort can be produced once their Patents have run out.(brief summary of IC buy recomendation). I think Advair expires around 2013.

At a presentation given at Deutsche Bank 33rd Annual Health Care Conference Co said that it had a mature product pipeline and a stage development points. Has a steady revenue stream and strong cash position and will be cash generative this year although this is not necessarily consistant depending on its developments.

As Baylis mentions re VR147 they state that triptan is a big niche opportunity and phase 1 study early proof of concept product is safe and works, in that earlier relief is given when drug is inhaled. sp 60.5p

http://webcastingplayer.corporate-ir.net/player/PlayerHost.aspx?Ev

Should also of mentioned that they have continuing success with the Girohaler which the Co licenses out and are developing a variant of Girohaler for German Company Boehringer Ingelheim for use with their products.

Finals due to be announced on 22nd May.

understandable profit taking sp 56p but believe the sp is in upward trend. Holding for now.

Vectura Group said full year sales were up 80% to 25.2m, while pretax losses widened to 21.4m compared with a restated 8.5m last time.

The inhaled drug specialist said cash at its year-end point was 78.8m compared with 77.5m last year, and added that it has spent 29.7m in R&D, a 75% year-on-year increase.

The company said it is exploring partnering one or more of its proprietary programmes, including its migraine therapy, VR147, and its sexual dysfunction programme, which includes its inhaled drugs for erectile dysfunction, VR004, and premature ejaculation, VR776.

It said it was confident that it will achieve its goal of reaching a sustainable cash-generative position, aided by substantial milestones and royalties from its partners as its late-stage respiratory programmes are filed and come to market.

The company in a statement that its good performance was down to its acquisition of Innovata, a lung product specialist, in January 2007, for 131m in an all-share deal.

'This strong financial performance is attributable to the addition of the Innovata business, which contributed over 17m, or 68%, of revenues and 8.6m of earnings before interest, taxes, depreciation and amortisation (EBITDA).

'Our goal, to become a sustainable, self-funding principal player in the development of inhaled pharmaceutical products, has been strengthened by the acquisition and is validated by these results,' it said.

The acquisition of Innovata gave it established alliances with a number of additional companies, such as Baxter International, GlaxoSmithKline, Merck Generics (part of Mylan Inc), UCB and Otsuka Corp, the company said.

Company looking to be making headway. However, sold at 56p to book a good profit. If sp weakens again through lack of interest given general market conditions, I will consider repurchase.

LOOKS GOOD

Any idea what's going on here?

A good IMS, but the price is dropping rapidly

Red

Red - I was wondering about that too and the only thing I can find is that The Naked Trader announced on Friday he'd sold his shares in Vectura.

As I commented on the Naked Trader thread, his buys and sells move the market quite dramatically nowadays.

Well that was certainly some dip, but I would have thought such a dramatic change would have prompted some comment from the company even if it was " we no of no reason ..."

Is the dip over & done I wonder!

Not a profitable company at present, but quite highly rated by some analysts.

http://uk.finance.yahoo.com/q/ao?s=VEC.L

Even 87p would look good!


Red

VR496 (cystic fibrosis) * Phase II proof-of-concept study results on track to read out in March 2011

Final year results out today and looking good for the future. Broker target of 120.

Peel Hunt reiterates buy with 132 target.

QVA149 Phase III study meets primary endpoint
RNS
RNS Number : 0694L
Vectura Group plc
30 August 2012



QVA149 Phase III study meets primary endpoint in reducing exacerbations in COPD patients, filing in EU and Japan by end of year



· SPARK demonstrated QVA149 statistically significantly reduced rate of moderate-to-severe exacerbations compared to glycopyrronium 50 mcg1



· Study showed QVA149 statistically significantly reduced overall exacerbation rates compared to glycopyrronium 50 mcg and open-label tiotropium 18 mcg1



· SPARK is the final study of the IGNITE Phase III clinical trial program intended for initial regulatory filings



Chippenham, UK - 30 August 2012: Vectura Group plc ("Vectura"; LSE: VEC) confirms the information released today by Novartis that results from the fifth QVA149 (indacaterol maleate / glycopyrronium bromide) Phase III study, SPARK, met its primary endpoint of a reduced rate of moderate-to-severe COPD exacerbations compared toglycopyrronium bromide (Seebri® Breezhaler®)1. SPARK is the final study intended for initial regulatory filings of QVA149 in Europe and Japan, which are expected in Q4 2012. US filing of QVA149 is expected at the end of 2014. To date, the first five studies of the IGNITE QVA149 Phase III clinical trials program have all met their primary endpoints of efficacy, safety, exercise endurance, and reduction of exacerbations1-5.



SPARK met its primary endpoint by demonstrating that patients treated with once-daily (QD) investigational QVA149 for 64 weeks demonstrated a clinically meaningful and statistically significant lower rate of moderate-to-severe COPD exacerbations compared to patients treated with QD glycopyrronium 50 mcg (p=0.038)1. The study also showed that the rate of moderate-to-severe exacerbations was numerically lower (p=0.096) in patients on QVA149 compared to open-label (OL) tiotropium 18 mcg1.



A further analysis of the data demonstrated that QVA149 was statistically significantly more effective in reducing the overall rate of all exacerbations (mild, moderate and severe) compared to glycopyrronium 50 mcg (p=0.001) and OL tiotropium 18 mcg (p=0.002)1. The adverse event (AE) profile of QVA149 was similar to both glycopyrronium 50 mcg and OL tiotropium 18 mcg1.



The management of COPD exacerbations is important to both patients and physicians, as exacerbations can impose a significant burden of morbidity, mortality, reduced quality of life and healthcare costs6,7. Frequent exacerbations are linked to an accelerated decline in lung function8,9 and patients are also known to have a poorer quality of life10. Admissions to hospital due to exacerbations are increasing11 and patients with more severe underlying disease account for around 70% of the direct medical costs of COPD12.



SPARK was a 64-week, multi-center, randomized, double-blind, parallel-group, active controlled study designed to evaluate the effect of QVA149 (indacaterol maleate 110 mcg / glycopyrronium 50 mcg) QD versus glycopyrronium 50 mcg and QD OL tiotropium 18 mcg on moderate-to-severe COPD exacerbations in 2,224 patients with severe to very severe COPD1.



QVA149 is an investigational inhaled, once-daily, fixed-dose combination of the long-acting beta2-adrenergic agonist (LABA) indacaterol maleate, and the investigational long-acting muscarinic antagonist (LAMA) glycopyrronium bromide, being investigated for the treatment of COPD in the Phase III IGNITE clinical trial program. IGNITE is one of the largest international clinical trial programs in COPD comprising 10 studies in total with more than 7,000 patients across 42 countries1-5,13-20. The first five studies (ILLUMINATE, SHINE, BRIGHT, ENLIGHTEN, SPARK) have already completed in 2012 with three additional studies (BLAZE, ARISE, BEACON) expected to complete by the end of the year. The studies are designed to investigate efficacy, safety and tolerability, exercise endurance, exacerbations, breathlessness and quality of life1-5,13-17.



Dr Chris Blackwell, Chief Executive of Vectura, commented:



"The SPARK study demonstrated a meaningful reduction in exacerbations in COPD patients; something that is of major benefit for patients and doctors and eases the burden of healthcare costs. We look forward to more detailed data from both glycopyrronium bromide (NVA237) and QVA149 at the upcoming European Respiratory Society meeting in Vienna in early September with the first filings for QVA149 expected in Europe and Japan by the end of this year."

Japan approves Vectura's inhaler capsules
Fri 28 Sep 2012

VEC - Vectura Group

Vectura Group 86.00p +1.78%



LONDON (SHARECAST) - Shares of Cambridge-based Vectura rose after it confirmed the Japanese government has approved its Seebri inhalation capsules used in inhaler devices.

The treatment, which will be available to patients and physicians in Japan by year-end, will trigger a £2.5m milestone payment for Vectura from its partner Novartis.

"The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Seebri (glycopyrronium bromide) Inhalation Capsules 50 mcg administered through the Breezhaler device, as a once-daily, long-term, inhaled maintenance bronchodilator treatment for the relief of various symptoms due to airway obstructive disease in chronic obstructive pulmonary disease (chronic bronchitis and emphysema)," said Vectura in a company statement.

It is the first approval for glycopyrronium bromide (Seebri) in COPD (chronic obstructive pulmonary disease), with further approval expected in the EU in 2012, the group explained.

Vectura Chief Executive Dr Chris Blackwell commented: "The approval of Seebri Inhalation Capsules in Japan is an important event for Vectura, triggering a $2.5m milestone and further validation of our late stage respiratory platform."

"Seebri Inhalation Capsules provides doctors and patients with a much needed, once-daily, treatment option for COPD, a condition that can lead to death and is increasing in prevalence in Japan and worldwide

The European Commission approves Seebri Breezhaler


http://www.moneyam.com/action/news/showArticle?id=4455346

QVA149 is filed as a treatment for COPD in Europe
RNS
RNS Number : 5041P
Vectura Group plc
25 October 2012





QVA149 is filed as a treatment for COPD in Europe





Chippenham, UK - 25 October 2012: Vectura Group plc ("Vectura"; LSE: VEC) confirms the information released today by Novartis that QVA149, (indacaterol maleate / glycopyrronium bromide) an investigational drug for chronic obstructive pulmonary disease (COPD) has been filed by Novartis for marketing authorisation with the European Medicines Agency (EMA), triggering a $5 million milestone payment to Vectura.





Novartis filed a marketing authorisation application to the EMA for QVA149, an investigational inhaled, once-daily, fixed-dose combination of indacaterol maleate and glycopyrronium bromide for the treatment of adult patients with COPD. The first five studies in the Phase III IGNITE clinical trial programme for QVA149 formed the basis of the filing. ILLUMINATE, SHINE, SPARK and BRIGHT met their respective superiority primary endpoints of FEV1 area under the curve (AUC) for 0-12 hours at 26 weeks versus salmeterol/fluticasone, mean trough FEV1 at 26 weeks versus both indacaterol maleate and glycopyrronium bromide, reduction in the rate of exacerbations versus glycopyrronium bromide, and exercise endurance time at 21 days versus placebo. The data from ENLIGHTEN demonstrated that QVA149 has a similar overall adverse event profile to placebo.





Dr Chris Blackwell, Chief Executive of Vectura, commented:



"The IGNITE programme is among the largest COPD clinical trial programmes performed, the results from which provide strong support as to the effectiveness and safety of QVA149 and its potential to treat patients suffering from this progressive disease, a multi-billion dollar market that is expected to see continued growth. Today's news follows the recent approval of Seebri® Breezhaler® in Europe and Canada and Seebri® Inhalation Capsules in Japan, further highlighting Vectura's expertise in the respiratory therapeutic area."





- Ends -

Notice of Results
RNS
RNS Number : 5893P
Vectura Group plc
26 October 2012



Vectura Group plc



Date of announcement of Interim Results for six months ended 30 September 2012





Chippenham, UK - 26 October, 2012: Vectura Group plc (LSE: VEC), will be announcing its results for the six months ended 30 September, 2012 on Tuesday 20 November 2012. A webcast of the event will be available on the Company's website at www.vectura.com.

QVA149 marketing application filed in Japan
RNS
RNS Number : 5150Q
Vectura Group plc
07 November 2012



QVA149 marketing application filed in Japan for once-daily maintenance treatment of COPD





Chippenham, UK - 7 November 2012: Vectura Group plc ("Vectura"; LSE: VEC) confirms the information released today by Novartis Pharma K.K., announcing that it has submitted an application in Japan for the registration of QVA149, an investigational fixed dose combination of two long-acting inhaled bronchodilators (indacaterol maleate and glycopyrronium bromide) as a once-daily treatment for chronic obstructive pulmonary disease (COPD).



COPD is a chronic, progressive lung disease that is caused by the inhalation of harmful substances such as cigarette smoke over a long period. Its major symptoms include cough, sputum, and dyspnea on exertion. COPD not only greatly decreases the quality of life for patients, but is also a life-threatening disease because its symptoms progress and might eventually lead to respiratory failure.



The application for QVA149 was filed to the European Medicines Agency in October 2012 and the US application is planned for 2014.



Novartis also received approval for glycopyrronium bromide in Japan in September 2012 (SeebriÒInhalation Capsules, 50 mg), and was approved in the EU during the same month (under the trade name Seebri® Breezhaler®). The product has since been launched in Germany and the UK and approvals have also been granted in Canada and Australia.



Dr Chris Blackwell, Chief Executive of Vectura:

"QVA149 continues to make excellent progress with its potential to treat patients suffering from COPD. This disease is progressive and debilitating for sufferers."

sp steadily moving up,some good news due?

breaking out?

20 February 2013

Chippenham, UK 20 Feb 2013: Vectura Group plc ("Vectura"; LSE: VEC) announced today that that Dr Chris Blackwell, Vectura’s Chief Executive Officer, is scheduled to present at the Citi 2013 Global Healthcare Conference on Monday, 25th February 2013, at 15:00 PST. The conference will be held from February 25th – 26th, 2013 at the Hilton New York Hotel in New York City.

The presentation will be webcast live and can be reached on the following link

http://www.vectura.com/investors/reports/2013.aspx

Listeners are encouraged to visit the site at least 15 minutes prior to the scheduled presentation to register, download and install any necessary audio software.

One of the Naked Traders tips for 2014

19 Dec Investec 170.00 Buy
19 Dec Canaccord... 150.00 Buy
19 Dec Finncap 180.00 Buy

cheers dc

8 Jan JP Morgan... N/A Overweight
6 Jan JP Morgan... 200.00 Overweight

Vectura Group PLC (VEC:LSE) set a new 52-week high during Friday's trading session when it reached 149.75. Over this period, the share price is up 62.40%.

Exciting times for this company.

200p I imagine in 2014.

Huge market in Germany.

Swedish approval of AirFluSal Forspiro

RNS


RNS Number : 6121X

Vectura Group plc

14 January 2014








Vectura Group plc



Swedish Regulatory Authority confirm approval of AirFluSal® Forspiro®





Chippenham, UK - 14 January 2014: Vectura Group plc (LSE: VEC; "Vectura" or "the Company") confirms that our partner, Sandoz, has today received Swedish marketing authorisation for AirFluSal® Forspiro® (formerly known as VR315), an innovative new inhaler for patients with asthma and chronic obstructive pulmonary disease (COPD).



The product was first approved in Denmark on December 18th, 2013 and Germany on January 13th, 2014. 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.



Sweden has approved the 50-500µg and 50-250µg dosage forms for the continuous treatment of patients above 12 years of age with persistent asthma or for symptomatic treatment of COPD in the same patient group. The product's safety, efficacy and equivalence have been proven in multiple clinical trials1,2.



The receipt of the marketing authorisations in Sweden, Germany and Denmark follows the successful completion of EU decentralised procedures also including Norway for the 50-500 µg and 50-250 µg dosage forms and for the 50-500 µg dosage form Germany, Belgium, Bulgaria, Hungary, Luxembourg and Romania. We will communicate as and when further market approvals are received.



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 recognized quality seal awarded by the Design Zentrum Nordrhein Westfalen in Essen, Germany.



[1] P Kuna, I Gath, U Thyroff-Friesinger, S Jones. Equivalence of an innovative multidose salmeterol/fluticasone dry powder inhaler vs

comparator in paediatric asthma. Submitted ERS - Reference September 2013

[2]Sandoz data on file

German approval of AirFluSal Forspiro

RNS


RNS Number : 5123X

Vectura Group plc

13 January 2014








Vectura Group plc



German Regulatory Authority confirm approval of AirFluSal® Forspiro®





Chippenham, UK - 13 January 2014: Vectura Group plc (LSE: VEC; "Vectura" or "the Company") confirms that our partner, Sandoz, has today received German marketing authorisation for AirFluSal® Forspiro® (formerly known as VR315), an innovative new inhaler for patients with asthma and chronic obstructive pulmonary disease (COPD). The receipt of the German marketing authorisation by Sandoz triggers a milestone payment to Vectura of €1.5 million.

The product was first approved in Denmark on December 18th, 2013. 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.

Germany has approved the 50µg-500µg dosage form for the continuous treatment of patients above 12 years of age with persistent asthma or for symptomatic treatment of COPD in the same patient group. The product's safety, efficacy and equivalence have been proven in multiple clinical trials1,2.

"This approval further de-risks our high value respiratory generic portfolio in Europe and the Rest of the World and, provides a significant cash milestone to Vectura." said Chris Blackwell, CEO of Vectura. "Once launched, the royalty stream from AirFluSal® Forspiro® will contribute to Vectura's differentiated top line growth".

The receipt of the marketing authorisations in Germany and Denmark follows the successful completion of EU decentralised procedures which also include Belgium, Bulgaria, Hungary, Luxembourg, Romania, Sweden and Norway. We will communicate as and when further market approvals are received.



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 recognized quality seal awarded by the Design Zentrum Nordrhein Westfalen in Essen, Germany.



[1] P Kuna, I Gath, U Thyroff-Friesinger, S Jones. Equivalence of an innovative multidose salmeterol/fluticasone dry powder inhaler vs

comparator in paediatric asthma. Submitted ERS - Reference September 2013

[2]Sandoz data on file

-Ends-

14 Jan N+1 Singer 110.00 Sell
14 Jan Finncap 180.00 Buy

Hungary approval of AirFluSal Forspiro

RNS


RNS Number : 8443X

Vectura Group plc

16 January 2014



Hungarian Regulatory Authority confirm approval of AirFluSal® Forspiro®





Chippenham, UK - 16 January 2014: Vectura Group plc (LSE: VEC; "Vectura" or "the Company") confirms that our partner, Sandoz, has received marketing authorisation in Hungary for AirFluSal® Forspiro® (formerly known as VR315), an innovative new inhaler for patients with asthma and chronic obstructive pulmonary disease (COPD).

The product was first approved in Denmark on December 18th, 2013, with subsequent marketing authorisations received earlier this week in Germany and Sweden. 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.

Hungary has approved the 50-500µg dosage form for the continuous treatment of patients above 12 years of age with persistent asthma or for symptomatic treatment of COPD in adults. The product's safety, efficacy and equivalence have been proven in multiple clinical trials1,2.

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 Vecturaas 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 recognized quality seal awarded by the Design Zentrum Nordrhein Westfalen in Essen, Germany.



[1]P Kuna, I Gath, U Thyroff-Friesinger, S Jones. Equivalence of an innovative multidose salmeterol/fluticasone dry powder inhaler vs

comparator in paediatric asthma. Submitted ERS - Reference September 2013

[2]Sandoz data on file

-Ends-

:-))

Romanian approval of AirFluSal Forspiro

RNS


RNS Number : 8026Y

Vectura Group plc

29 January 2014






Vectura Group plc



Romanian Regulatory Authority confirm approval of AirFluSal® Forspiro®





Chippenham, UK - 29 January 2014: Vectura Group plc (LSE: VEC; "Vectura" or "the Company") confirms that our partner, Sandoz, has received marketing authorisation in Romania for AirFluSal® Forspiro® (formerly known as VR315), an innovative new inhaler for patients with asthma and chronic obstructive pulmonary disease (COPD). The receipt of the Romanian marketing authorisation by Sandoz triggers a milestone payment to Vectura of €1.5 million.

The product was first approved (and now launched) in Denmark on December 18th, 2013 with subsequent market authorisations received earlier in January 2014 in Germany, Sweden and Hungary. 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.

Romania has approved the 50µg-500µg dosage form for the continuous treatment of patients above 12 years of age with persistent asthma or for symptomatic treatment of COPD. The product's safety, efficacy and equivalence have been proven in multiple clinical trials1,2.

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 recognized quality seal awarded by the Design Zentrum Nordrhein Westfalen in Essen, Germany.



[1] Kuna, I. Gath, U. Thyroff-Friesinger, S. Jones. Equivalence of fluticasone propionate/salmeterol delivered via new multi-dose dry powder inhaler and accuhaler™ in adolescent and adult asthma. Ajrccm conference.2013.187.1_MeetingAbstracts.A2611



[2]Sandoz data on file

-Ends-

Bulgarian approval of AirFluSal Forspiro

RNS


RNS Number : 2893Z

Vectura Group plc

04 February 2014






Vectura Group plc



Bulgarian Regulatory Authority confirm approval of AirFluSal® Forspiro®





Chippenham, UK - 4 February 2014: Vectura Group plc (LSE: VEC; "Vectura" or "the Company") confirms that our partner, Sandoz, has received Bulgarian marketing authorisation for AirFluSal® Forspiro® (formerly known as VR315), an innovative new inhaler for patients with asthma and chronic obstructive pulmonary disease (COPD).

The product was first approved (and now launched) in Denmark on December 18th, 2013 with subsequent market authorisations received in January 2014 in Germany, Sweden, Hungary and Romania. 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.

Bulgaria has approved the 50µg-500µg dosage form for the continuous treatment of patients above 12 years of age with persistent asthma or for symptomatic treatment of COPD. The product's safety, efficacy and equivalence have been proven in multiple clinical trials1,2.

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 recognized quality seal awarded by the Design Zentrum Nordrhein Westfalen in Essen, Germany.



[1] Kuna, I. Gath, U. Thyroff-Friesinger, S. Jones. Equivalence of fluticasone propionate/salmeterol delivered via new multi-dose dry powder inhaler and accuhaler™ in adolescent and adult asthma. Ajrccm conference.2013.187.1_MeetingAbstracts.A2611



[2]Sandoz data on file





-Ends-

Norwegian approval of AirFluSal Forspiro

RNS


RNS Number : 7281Z

Vectura Group plc

10 February 2014






Vectura Group plc



Norwegian Regulatory Authority confirm approval of AirFluSal® Forspiro®





Chippenham, UK - 10 February 2014: Vectura Group plc (LSE: VEC; "Vectura" or "the Company") confirms that our partner, Sandoz, has received Norwegian marketing authorisation for AirFluSal® Forspiro® (formerly known as VR315), an innovative new inhaler for patients with asthma and chronic obstructive pulmonary disease (COPD).

The product was first approved (and now launched) in Denmark on December 18th, 2013 with subsequent market authorisations received in 2014 in Germany, Sweden, Hungary, Romania and Bulgaria. 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.

Norway has approved the 50µg-500µg and 50µg-250µg dosage forms for the continuous treatment of patients above 12 years of age with persistent asthma or for symptomatic treatment of COPD. The product's safety, efficacy and equivalence have been proven in multiple clinical trials1,2.

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 recognized quality seal awarded by the Design Zentrum Nordrhein Westfalen in Essen, Germany.



[1] Kuna, I. Gath, U. Thyroff-Friesinger, S. Jones. Equivalence of fluticasone propionate/salmeterol delivered via new multi-dose dry powder inhaler and accuhaler™ in adolescent and adult asthma. Ajrccm conference.2013.187.1_MeetingAbstracts.A2611



[2]Sandoz data on file

-Ends-

Belgian approval of AirFluSal Forspiro

RNS


RNS Number : 9176Z

Vectura Group plc

12 February 2014






Vectura Group plc



Belgian Regulatory Authority confirm approval of AirFluSal® Forspiro®





Chippenham, UK - 12 February 2014: Vectura Group plc (LSE: VEC; "Vectura" or "the Company") confirms that our partner, Sandoz, has received Belgian marketing authorisation for AirFluSal® Forspiro® (formerly known as VR315), an innovative new inhaler for patients with asthma and chronic obstructive pulmonary disease (COPD). The receipt of the Belgian marketing authorisation by Sandoz triggers a milestone payment to Vectura of €1.5 million.

The product was first approved (and now launched) in Denmark on December 18th, 2013 with subsequent market authorisations received in 2014 in Germany, Sweden, Hungary, Romania, Bulgaria and Norway. 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. The product has now been launched in Denmark and Germany.

Belgium has approved the 50µg-500µg dosage form for the continuous treatment of patients above 12 years of age with persistent asthma or for symptomatic treatment of COPD. The product's safety, efficacy and equivalence have been proven in multiple clinical trials1,2.

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 recognized quality seal awarded by the Design Zentrum Nordrhein Westfalen in Essen, Germany.



[1] Kuna, I. Gath, U. Thyroff-Friesinger, S. Jones. Equivalence of fluticasone propionate/salmeterol delivered via new multi-dose dry powder inhaler and accuhaler™ in adolescent and adult asthma. Ajrccm conference.2013.187.1_MeetingAbstracts.A2611



[2]Sandoz data on file

-Ends-

Interim Management Statement

RNS


RNS Number : 9525Z

Vectura Group plc

13 February 2014






Vectura Group plc



Interim Management Statement



Chippenham, UK - 13 February 2014: Vectura Group plc (LSE: VEC) ("Vectura"), today publishes its Interim Management Statement for the period 1 October 2013 to 13 February 2014.



Financial update



On 18 November 2013, Vectura announced its interim results for the six months to 30 September 2013, reporting a loss before tax of £1.2m and cash of £65.5m.



Vectura's financial performance from 1 October 2013 to date has been in line with the Board's expectations.



Pipeline update

During the period, our partner, Sandoz, announced that it had received marketing authorisation for AirFluSal® Forspiro® (formerly known as VR315), an innovative new inhaler for patients with asthma and/or chronic obstructive pulmonary disease (COPD). To date, marketing authorisations have been received from Denmark, Germany, Sweden, Hungary, Romania, Bulgaria, Norway and Belgium and AirFluSal® Forspiro® has been launched in Denmark and Germany. The approvals in Germany, Romania and Belgium each triggered milestone payments to Vectura of €1.5 million (circa. £1.2m). The Company will continue to provide updates, as and when further market approvals are received.



The roll-out of Seebri® Breezhaler® continues and Novartis reported sales of $58m for the 2013 calendar year on 29 January 2014. Our second partnered programme with Novartis, Ultibro® Breezhaler® (formerly QVA149), received approvals in Japan1 and Europe in September 2013. Novartis reported sales of $6m for the quarter ended 31 December 20132, with new royalty streams to Vectura anticipated from Q1 2014.



Novartis expect the US filing of Seebri® Breezhaler® and Ultibro® Breezhaler® to occur in Q4 2014.



In October 2013, GSK announced that BREO™ ELLIPTA™ for the treatment of COPD was available for sale in the US, followed in December 2013, by the approval by the US Food and Drug Administration (FDA) of ANORO™ ELLIPTA™. Vectura receives royalties from sales of these two products up to a cap of £13m per annum.



Board update

In November 2013, the Company announced the appointment of Bruno Angelici to the Board of Vectura. Bruno became Chairman with effect from 1 February 2014.



Dr Chris Blackwell, Chief Executive of Vectura commented:



"Vectura has continued to make strong progress in the period. The ongoing approvals and launch of AirFluSal® Forspiro® de-risks our high value respiratory generic portfolio in Europe and the rest of world and triggers another new valuable royalty stream in addition to the launch of Ultibro® Breezhaler®, together with the continuing and successful roll-out of Seebri® Breezhaler®".





1 Seebri® inhalation capsules in Japan

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









13 Feb N+1 Singer 110.00 Sell
13 Feb Finncap 180.00 Buy

THANKS DREAMCATCHER, WHEN DO WE SELL.

? Going to ask you the same. :-))

Baylis and DC
just found this one know little about them but reading up , see a host of countries approval for marketing and USA hopefully this year, but nothing about the UK, or has it been approved here earlier

26 March 2014 Investor Day, London
21 May 2014 Final Results for the year ending 31 March 2014
19 September 2014 Annual General Meeting
18 November 2014 Interim Results for the six months ending 30 September 2014

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.

-Ends-

11 Mar N+1 Singer 159.00 Hold

Acquisition of Activaero

http://www.moneyam.com/action/news/showArticle?id=4771907
-------------------------------------------------------------------------------------
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."





-Ends-

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

-Ends-

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.

VEC Vectura- Pharma/Bio co. Long,secured deals over last few days with some big US companys Risky but broker backing is very strong.



Date Broker Rec. Price Old target price New target price Notes
08 Jan 15 Oriel Securities Buy 150.50 207.00 207.00 Reiterates
08 Jan 15 Investec Buy 150.50 148.00 163.00 Upgrades
08 Jan 15 N+1 Singer Hold 150.50 147.00 156.00 Retains
07 Jan 15 Canaccord Genuity Buy 150.50 192.00 192.00 Reiterates
06 Jan 15 finnCap Buy 150.50 202.00 202.00 Reiterates
05 Jan 15 JP Morgan Cazenove Overweight 150.50 230.00 230.00 Reiterates

Lifted from across the road......

Good news today - and it seems $35m will be coming VEC's way soon if I follow this morning's comment from Finncap correctly....

"Vectura: NVA237/QVA149 regulatory submission (BUY)

The regulatory submissions of NVA237 and QVA149 to the US regulator were completed by Novartis (Vectura’s licensee), as expected, in Q4 2014. On acceptance of the dossiers (which can take up to 60 days), Vectura will receive milestone payments (we estimate US$35m), with further milestone payments due on regulatory approval, and royalties of an estimated 5% payable on sales in the US.

Novartis has also released positive top-line clinical results from the Phase III trials performed to support US registration, with both drugs demonstrating statistically significant and clinically meaningful improvements in lung function. We make no changes to our forecasts, reiterating our 202p target price and our Buy recommendation."

From Peel Hunt wed - nice 248p target price.

Janssen's prior acquisition of Respivert is certainly an intriguing portent....

"Vectura (Buy TP 248p)
Janssen deal.

Vectura announced a deal with Janssen Biotech (part of J&J and developer of approved drugs such as Zytiga) for the exclusive development of Janssen's novel anti-inflammatory therapies in development for the treatment of asthma/COPD. The collaboration will initially focus on the development of a Phase 2 candidate, with the potential to include additional clinical-stage candidates. Janssen will lead the clinical development of the assets, with Vectura providing its expertise and technologies (devices, formulation) in dry powder inhalers (DPI).

This deal is in line with the strategy outlined at the Business Review Day last March, which unveiled Vectura's Gyrohaler-related devices platform, which includes several different device options, as an approved multi-dose DPI platform available for licensing. Detailed deal terms are not disclosed, but we would imagine a typical structure of modest 7 figure upfronts and milestones together with full FTE funding of Vectura resources (people) and mid single digit royalties on eventual sales. Such a structure implies no rise in Vectura's own R&D investment, though will utilise some of the bandwidth of its employee base, in return for near-term milestones and development services payments and a share in the upside should the products get to market.

The precise products are not disclosed, but note that Janssen acquired the UK companyRespivert a few years ago, which has a promising portfolio of anti-inflammatory compounds in development. This deal is a positive step forward, adding a further large pharma partner and is exactly in line with Vectura's stated strategy and is a validation of its status as a partner of choice in targeting airways diseases. We make no changes to our valuation at the moment pending more information on this programme in the future."

More here about this being a "multi-million dollar" deal:

Http://www.businessweekly.co.uk/biomedtech-/18009-vectura-clinches-multi-million-dollar-janssen-deal

Extract:

"Tuesday, 06 January 2015 09:08
Tony Quested

Vectura clinches multi-million dollar Janssen deal
.
Vectura in Cambridge UK has secured a landmark deal with US heavyweight Janssen Biotech Inc to develop inhaler technology to treat asthma and COPD (chronic obstructive pulmonary disease).

While no financial deals were disclosed to the markets, Business Weekly understands the payback stacks up to several million dollars.

The deal comprises handsome upfront and development milestones and a tiered royalty on net sales.

etc"

Vectura to present at JP Morgan Conference

RNS

RNS Number : 5910B
Vectura Group plc
09 January 2015




Vectura Group plc


Vectura to present at the 33rd Annual J.P. Morgan Healthcare Conference, San Francisco

Chippenham, UK - 9 January 2015: Vectura Group plc ("Vectura"; LSE: VEC) announces today that it is scheduled to present at the 33rd Annual J.P. Morgan Healthcare Conference on Wednesday, 14 January 2014, at 4:30pm PST (12.30am 15 January GMT). The conference runs from 11-15 January 2015, at the Westin St. Francis Hotel in San Francisco, CA.

The presentation will be webcast live and can be reached from Vectura's website at http://www.vectura.com/investors/reports-presentations/2015.aspx. Listeners are encouraged to visit the site at least 15 minutes prior to the scheduled presentation to register, download and install any necessary audio software. A PDF of the presentation will also be available on Vectura's website at the same time.

-Ends-


Enquiries

Vectura Group plc
+44 (0)1249 667700
Karl Keegan, Chief Corporate Development Officer
Fleur Wood, Corporate Investor Relations



FTI Consulting
+44 (0)20 3727 1000
Ben Atwell / John Dineen / Ulla Lundhus

6 Jan 2015 Vectura Group PLC VEC JP Morgan Cazenove Overweight 142.38 144.75 - - Reiterates

NDA acceptance for QVA149 and NVA237
RNS
RNS Number : 6561G
Vectura Group plc
05 March 2015



Vectura Group plc



US FDA filing acceptance of NDAs for QVA149 and NVA237



Chippenham, UK - 5th March 2015: Vectura Group plc (LSE: VEC; "Vectura" or "the Company"), confirms that Novartis' New Drug Applications (NDAs) for QVA149 and NVA237 for the long-term maintenance treatment of chronic obstructive pulmonary disease (COPD) have been accepted for review by the US Food and Drug Administration (FDA). The filings were submitted by Novartis in Q4 2014. The acceptances trigger milestone payments to Vectura of $12.5m and $7.5m respectively.

-Ends-

A moderately good start to the year and climbing Sp has been lost after they ann a problem with major drugs co SKB ( DYOR )...it seems previous deals have been rather poor, with VEC getting rather little for "better" powders. Now they appear to have the inhaler/delivery improved further. . . you'd expect that would mean they'd share the profits - but it seems there is an issue and SKB have the upper hand ( Unless VEC can find ANOther to distribute the product . . . makes me wonder if BTG Sales force couldn't do this as they should by now have the warehousing ).
One wonders if the income won't dip in the short-term meaning there will be a cash-call - Oh dear.
Their products appear to be good-enough against existing puffers . . . . but to get the Market excited, I think they need to make it far clearer how these differ and why one model is better-suited, compared with another they make . . .otherwise it looks like clutter, to my mind.
8 Sept 2016...sp ~150p
EDIT (24April2017)-sp ~150p nothing worthwhile to report, I guess.
EDIT(20Oct2018)-oh dear sp 70p ish.... mighty fallen... anyone?
EDIT (25NoV2018)- Seems VEC's sp was hardly knocked with the failure of asthma-trial . . . you'd think just giving a puff to someone with asthma would show if it worked - if not, then move-on. Why put money into Trials if it didn't hold great promise?