BAYLIS
- 09 Oct 2007 22:00
Powered by IST's
Guscavalier
- 09 May 2008 20:47
- 8 of 88
moving up in a weak market sp 51.25p
BAYLIS
- 12 May 2008 11:18
- 9 of 88
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
Guscavalier
- 15 May 2008 10:00
- 10 of 88
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
Guscavalier
- 15 May 2008 10:09
- 11 of 88
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.
Guscavalier
- 17 May 2008 13:19
- 12 of 88
understandable profit taking sp 56p but believe the sp is in upward trend. Holding for now.
Guscavalier
- 22 May 2008 09:28
- 13 of 88
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.
XSTEFFX
- 15 Jul 2009 10:48
- 14 of 88
LOOKS GOOD
Red Underwing
- 07 Mar 2011 12:43
- 15 of 88
Any idea what's going on here?
A good IMS, but the price is dropping rapidly
Red
Harry6
- 07 Mar 2011 18:50
- 16 of 88
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.
Red Underwing
- 09 Mar 2011 22:57
- 17 of 88
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
BAYLIS
- 24 Mar 2011 20:13
- 18 of 88
VR496 (cystic fibrosis) * Phase II proof-of-concept study results on track to read out in March 2011
BAYLIS
- 13 Jul 2011 19:56
- 19 of 88
doodlebug
- 26 Apr 2012 10:14
- 20 of 88
Final year results out today and looking good for the future. Broker target of 120.
doodlebug
- 26 Apr 2012 13:22
- 21 of 88
Peel Hunt reiterates buy with 132 target.
dreamcatcher
- 02 Sep 2012 17:22
- 22 of 88
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."
dreamcatcher
- 28 Sep 2012 15:40
- 23 of 88
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
dreamcatcher
- 01 Oct 2012 09:41
- 24 of 88
dreamcatcher
- 25 Oct 2012 07:08
- 25 of 88
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 -
dreamcatcher
- 26 Oct 2012 07:10
- 26 of 88
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.
dreamcatcher
- 07 Nov 2012 16:29
- 27 of 88
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."