Vec appoint new delivery Excecutive Vectura appoints Sharon Johnson to new delivery management role 10 February 2020 | 07:57am StockMarketWire.com - Pharmaceuticals company Vectura said it had appointed Sharon Johnson to the newly-created leadership role of executive vice president for delivery management. Johnson was most recently senior vice president, global quality and regulatory affairs at Catalent. In her new role, Johnson would support innovation, customer focus and growth as the company continued with its strategic development as an inhalation specialist in the pharmaceutical services space. Story provided by StockMarketWire.com
Buy Back ,Price moving up It good top see VEC moving north again, over all VEC has gained over 15%, since the buyback started ,VEC should break through the 100p ceiling soon. BE HAPPY DAVE
Topped up VEC… XXXX Not been lucky with this sector at all , Was looking @ BIIB ( Alzheimer , “come back news” had a big recent rise ! ) Big boys obviously aware of news before. & VRTX ( Cystic Fibrous … NHS deal )… both on main news Friday 25th October 2019.
Topped up VEC… XXXX E-mail ( W ) Consolidation just done money paid on 25th Oct .
Topped up VEC… XXXX Return of capital ( 6p per share ) Consolidation 12p for 13p.
V.E.C up date look plus returning £50m to shareholders update Chippenham, UK - 17 July 2019: Vectura Group plc (LSE: VEC) (“Vectura” or “the Group”) today confirms its R&D investment priorities, announces a proposed £50 million capital return and provides an unaudited pre-close trading update. Paul Fry, Interim Chief Executive Officer of Vectura, commented: "Vectura has a rich heritage in developing innovative inhaled drug delivery solutions and we believe we provide a differentiated offering to partners. We see an attractive, growing market opportunity for these services, and this is where our focus is set for the future. Today we are confirming that our R&D investment priorities will be clearly aligned to this partnering focus. "Given the Group’s focus is now primarily on organic growth, with lower risk R&D spend supported by partners, it is our intention to return £50 million to shareholders this year, with the Board continuing to review our capital allocation strategy on a regular basis. “Vectura made a positive start to trading during H1 2019, with flutiform® product supply revenues making an important contribution to growth. We are pleased to be able to re-confirm our financial guidance and outlook expectations for 2019.” R&D investment priorities Vectura is a provider of innovative inhaled drug delivery solutions that enable partners to bring their medicines to patients. With differentiated proprietary technology and pharmaceutical development expertise, Vectura is one of the few companies globally with the device, formulation and development capabilities to deliver a broad range of complex inhaled therapies. Following the successful build out of its generics portfolio, Vectura will continue to focus on securing new partner contracts for the development of inhaled therapies, including novel molecules. For these contracts the Group will move towards offering development services where a smaller proportion of the overall contract value is delivered through contingent milestones. The Group will continue to invest in new proprietary platform technologies, creating intellectual property to drive future licensing and royalty income. In 2018, the Group invested approximately 55% (c. £30 million) of its total R&D spend in platform technologies and existing partnered programmes. The R&D investment that has historically been focused outside these priorities will be progressively re-deployed towards new partner contracts. Return of capital In light of the Group’s reducing R&D risk profile, future cash generation expectations and strong cash balance, the Board has approved, in principle, a capital return of approximately £50 million, commencing in 2019. The proposed return of capital is currently expected to be structured as a tender offer, although the Board continues to review other options. Further details regarding the specific mechanism for, and the timing of, the return of capital will be provided at the time of the Group’s interim results in September. The Board recognises that considerable financial upsides remain in the outlook for the Group, and, in the absence of future inorganic growth opportunities, it intends to make additional future ‘special’ returns of excess capital arising from operations or from material one-off events, by the most appropriate mechanism. Current trading and outlook Vectura made a positive start to trading in 2019, with flutiform® in-market demand and partner supply chain management resulting in product supply revenues being ahead of the Board’s expectations for H1 2019. Given the Group’s visibility of flutiform® product supply volumes for the rest of 2019, the Group expects this strong performance to continue into the second half of the year. Following a constructive end of Phase II meeting with the FDA in May, Vectura continues to seek a partner for VR647 Phase III development and commercialisation. Irrespective of the outcome of these discussions the Group maintains its financial guidance and outlook expectations for 2019.
Vec recieves £2.5 on European Market submission of QVM149 0700 +010: $2.5m milestone payment for QVM149 submission RNS Number : 0548A Vectura Group plc 24 May 2019 Vectura receives $2.5m milestone payment for the European regulatory submission of QVM149 BE HAPPY Dave Chippenham, UK - 24 May 2019: Vectura Group plc (LSE: VEC) (“Vectura” or “the Group”), announced today that it will receive a $2.5million milestone payment under an exclusive licence agreement with Novartis AG. The payment was triggered following the acceptance of Novartis’ valid Marketing Authorisation Application (MAA) by the EU Regulatory Authorities for the regulatory approval of QVM149. QVM149 is a potential new inhaled combination therapy for inadequately controlled asthma. Vectura’s Chief Executive Officer, James Ward-Lilley, said: “We are pleased to see the progression of the QVM149 program and the acceptance of the EU registration dossier ahead of its original timeline. Based on the strong Phase II study results for QVM149 presented at ATS this week, we believe this new asthma treatment has the potential to have a competitive profile and provide an important and compelling additional option for physicians and patients.” QVM149 combines comprehensive bronchodilation of indacaterol acetate (a LABA [long-acting beta agonist]) and glycopyrronium bromide (a LAMA [long-acting muscarinic receptor antagonists) with mometasone furoate (an inhaled corticosteroid) in a precise once-daily formulation delivered in a dry-powder inhaler device. Vectura and Sosei Heptares exclusively licensed glycopyrronium bromide and certain intellectual property relating to its use and formulation to Novartis in April 2005. Novartis is responsible for the development and commercialisation of QVM149. Vectura is due to receive a further milestone payment of $5.0 million on European regulatory approval of the product and thereafter royalties on net sales from launch.
Novatis release results for QVM149 dry powder asthma treatment Novartis phase II data for new inhaled combination treatment (QVM149) demonstrates significant improvements over current standard-of-care inhaled treatment • New inhaled combination for asthma treatment (indacaterol acetate, glycopyrronium bromide and mometasone furoate - IND/GLY/MF) was superior to the standard of care (long-acting beta-agonist/inhaled corticosteroid - LABA/ICS) in terms of lung function in a phase II study • In another phase II study, IND/GLY/MF was superior to placebo in lung function improvement irrespective of administration time of morning or evening • The combination of IND/GLY/MF is in development as a once-daily inhaled treatment for asthma, delivering the comprehensive bronchodilation of indacaterol/glycopyrronium and the established efficacy of mometasone via the dose-confirming Breezhaler® • IND/GLY/MF demonstrated a favorable safety and tolerability profile in both phase II studies Basel, May 22, 2019 - Novartis announced today that new phase II data for IND/GLY/MF (QVM149), an investigational, once-daily, fixed dose combination asthma treatment containing indacaterol acetate, glycopyrronium bromide and mometasone furoate, delivered with the dose-confirming Breezhaler® inhalation device, was presented at the 2019 annual international congress of the American Thoracic Society (ATS). In two phase II clinical studies, IND/GLY/MF was superior to the comparators, salmeterol/fluticasone propionate (a standard-of-care treatment) and placebo, separately by demonstrating improvement in lung function in patients with asthma. In one study, IND/GLY/MF also demonstrated improvements versus placebo irrespective of administration time of morning or evening. In the phase II CQVM149B2208 study (ClinicalTrials.gov Identifier: NCT03063086), both once-daily doses of IND/GLY/MF (150/50/160 Mu g, high-dose ICS; 150/50/80 Mu g, medium-dose ICS) met the primary endpoint with statistically significant improvements of peak FEV1 (forced expiratory volume in 1 second) versus twice daily salmeterol/fluticasone propionate (50/500 Mu g, high-dose ICS) with mean differences of 172 mL (95% CI: 137, 208) and 159 mL (95% CI: 123, 195), respectively (p<0.001). Additionally, compared with salmeterol/fluticasone propionate 50/500 Mu g twice a day, both high and medium doses of IND/GLY/MF met the secondary endpoint with statistically significant improvements (p<0.001) in FEV1AUC (FEV1 area under the curve) across both time intervals of FEV1AUC5min-1h and FEV1AUC5min-23h45min. “These results demonstrate that this novel combination offering dual bronchodilation plus an inhaled corticosteroid can provide further lung function benefits to patients with asthma beyond established therapies,” said Dr Henrik Watz, Pulmonary Research Institute at LungenClinic Grosshansdorf, Airway Research Center North, German Center for Lung Research. In study CQVM149B2209 (ClinicalTrials.gov Identifier: NCT03108027), once-daily IND/GLY/MF provided consistent and substantial lung function benefits over the entire 24-hour dosing interval in adult patients with asthma, irrespective of dosing time (morning or evening). The study met the primary endpoint by demonstrating the improved FEV1 for both morning and evening administrations of IND/GLY/MF versus placebo over 14 days, with mean differences of 610 mL (90% CI: 538, 681) and 615 mL (90% CI: 544, 687) respectively. The safety data from both studies suggest that IND/GLY/MF has a favorable safety and tolerability profile. The adverse events observed in the IND/GLY/MF groups were comparable to placebo (CQVM149B2209) and salmeterol/fluticasone propionate (CQVM149B2208) , with no serious adverse events reported in any treatment period in both studies. While phase III trials are ongoing, Novartis plans to present more data and analyses at future medical conferences to address the clinical and regulatory path forward for IND/GLY/MF delivered by Breezhaler®. “Despite the availability of numerous asthma treatments, more than one-third of asthma patients remain uncontrolled and continue to experience symptoms and/or exacerbations,” said Linda Armstrong, MD, Respiratory Development Unit Head. “These phase II studies’ results are a promising stride forward for this once daily combination. Together with a dose-confirming Breezhaler® inhalation device, which is well established in COPD, this new combination, if approved, has the potential to improve lives of those with uncontrolled asthma.” About QVM149 (IND/GLY/MF) The combination of indacaterol acetate, glycopyrronium bromide and mometasone furoate (IND/GLY/MF) is currently in development for the treatment of inadequately controlled asthma. This formulation combines comprehensive bronchodilation of indacaterol acetate (a LABA [long-acting beta agonist]) and glycopyrronium bromide (a LAMA [long-acting muscarinic receptor antagonists]) with mometasone furoate (high- or medium-dose ICS [inhaled corticosteroid]) in a precise once-daily formulation, delivered with the dose-confirming Breezhaler® device. Glycopyrronium bromide and certain use and formulation intellectual property were exclusively licensed to Novartis in April 2005 by Sosei Heptares and Vectura. Mometasone furoate is exclusively licensed to Novartis from a subsidiary of Merck & Co., Inc, Kenilworth, NJ, USA, for use in QVM149 (Worldwide excluding US).
Vec win £89m + against GSK It appears VEC have won their litigation against GSK in the US courts, and have been awarded £89m in partial damages up to 2019 . How ever further awards could be awarded ,as the court found GKN infringed VEC Patents wilfully and deliberately, That means VEC could double this award as the infringement will still carry on until 2021 .GKN may come to an out of court settlement . www.vectura.com/investors/stock-exchange-announcements BE HAPPY DAVE
Topped up VEC… XXXX Bed & Isa 73.71 / 73.62 Dropped in my favour not speedy took 45mins.
VEC up date looks good ,shares up 12.33% in morning trading 0700 +000: Pre-close trading update confirms good progress RNS Number : 0203M Vectura Group plc 03 January 2019 This contains inside information Pre-close trading update confirms good progress against 2018 goals Chippenham, UK - 03 January 2019: Vectura Group plc (LSE: VEC) (“Vectura” or “the Group”) today announces an unaudited 2018 pre-close trading update. The Group expects revenue to be in line with, and EBITDA to be materially above, current market consensus expectations. Vectura will report its preliminary results for the year ended 31 December 2018 on Tuesday 26 March 2019. Highlights: •Vectura revenues continue to grow in line with expectations, underpinned by positive in-market sales performance of: o flutiform® total in-market sales were up 8.6% for the 12 month period to September 2018 - Europe +3.7%, Japan +13.9% and rest of world (ROW) +19.7% - all at constant exchange rates (CER) compared to the 12 months to September 2017 o Ultibro® total in-market sales1 were up 12.2% for the 12 month period to September 2018 - Europe +9.7%, Japan -0.8% and ROW +27.3% - all at CER compared to the 12 months to September 2017 •Agreement signed with Hikma pharmaceuticals for the global development and commercialisation of generic versions of GSK’s Ellipta® portfolio, receiving an upfront milestone of US$15 million •Continuing to build and progress generic pipeline, including the Ellipta® portfolio, VR315 and VR2081 •Significant progress on nebulised portfolio, despite disappointing VR475 results, including positive VR647 Phase II data and the development of three new Vectura enhanced therapies, targeting niche or orphan disease segments •R&D transformation successfully creating capacity to support new programmes as well as cost efficiencies •Strong operational performance delivering EBITDA growth materially ahead of market expectations, with closing cash and cash equivalents of approximately £108 million James Ward-Lilley, Chief Executive Officer of Vectura, commented: “Vectura has made good progress in the year with positive top line performance, pipeline evolution aligned with our refocused investment strategy, and strong operational execution. We look forward to 2019 with key news flow on VR315, partnering of VR647, further disclosure and momentum on our new Vectura Enhanced Nebulised assets as well as Phase III results from QVM149, our inhaled triple combination therapy for asthma, partnered with Novartis.” Financial guidance The Group maintains its guidance that it expects to meet 2018 consensus revenue growth expectations. Adjusted EBITDA is expected to be materially ahead of market consensus expectations, due to overall revenue mix, productivity initiatives and margin improvements. The Group expects its R&D investment for the full year 2018 to be at, or around, the bottom of the £55 million to £65 million guidance range. Our 2019 guidance for R&D expenditure remains unchanged at £45 million to £55 million. Pipeline progress Inhaled generics Open-Inhale-Close dry powder inhaler device On 8 November 2018, Vectura signed a global agreement with Hikma for the development and commercialisation of generic versions of GSK’s Ellipta® portfolio, utilising Vectura’s proprietary Open-Inhale-Close (OIC) dry powder inhaler device, receiving an upfront milestone of $15 million. The new OIC development programmes are underway. VR315 (Hikma, US) Recruitment is progressing well on the repeat clinical study for VR315, and Hikma anticipates being able to submit data from the study to the US Food and Drug Administration (“FDA”) during 2019 to support its regulatory application, enabling a potential US launch in 2020, as previously communicated. VR2081 (Sandoz, US) Vectura is continuing its pMDI development work on VR2081, a generic version of an existing major inhaled combination therapy for asthma and COPD in the US, with the first clinical trial batches delivered to the Group’s partner Sandoz. VR410 (Pulmatrix, US) VR410 is a branded generic alternative to Spiriva® HandiHaler® (tiotropium bromide) in the US. Following a review of our generic pipeline priorities, Vectura and Pulmatrix have mutually agreed to terminate the agreement and cease further development of this project. Vectura Enhanced Nebulised Technology VR647 (Paediatric asthma, US) On 21 August 2018, two positive studies were completed; (Pharmacokinetic and Usability) supporting progression to a Phase III development programme. The Phase III study initiation is planned in 2019, following an end-of-phase II consultation with the FDA. As previously indicated, the Group will seek to partner VR647 development and commercialisation during 2019. VR475 (Severe adult asthma, EU) On 26 November 2018, Vectura announced that its Phase III study of VR475 in adult and adolescent patients with severe uncontrolled asthma did not meet its primary endpoint and the Group would not be pursuing further development and partnering of the programme. Whilst the primary endpoint did not achieve statistical significance, positive trends and clinically meaningful differences between VR475 and placebo, and versus conventionally nebulised budesonide, reinforce the differential characteristics of Vectura’s guided inhalation system versus conventional nebulisation. These data support our confidence in Vectura’s nebulised platform, including the ongoing VR647 programme, as well as the three additional earlier stage nebulised programmes using non-budesonide molecules. New VEC enhanced nebulised therapies (VeNT) programmes Vectura is progressing three new pipeline projects based on combining existing proven molecules with our proprietary breath controlled nebulised technology. These assets are targeting niche or orphan disease segments in multi-billion US dollar markets with individual peak year sales potential in excess of US$250 million, and are being developed for the inhaled management of cardiopulmonary vascular disease, cystic fibrosis and infection in post-transplant immunocompromised patients. Vectura will outline progress on these programmes during 2019. VR465 (Ablynx, ALX-0171 anti-RSV nanobody - a Sanofi Company) The results of the Ablynx ALX-0171 anti-RSV nanobody Phase II programme were positive for the primary endpoint of anti-viral efficacy and target exposure was achieved; however, consistent clinical efficacy was not observed across secondary endpoints. Sanofi has deprioritised this programme and is not continuing with it. Attendance at 37th Annual J.P. Morgan Healthcare Conference Vectura will be attending the 37th Annual J.P. Morgan Healthcare Conference, 7-10 January 2019 in San Francisco, California. James Ward-Lilley, CEO, will give a presentation at 9.30am PT on Thursday 10th January. Ends-
VEC loose U.K patent dispute with GlaxoSmithKline PLC Vectura Group PLC (VEC.LN) said Thursday that a U.K. court ruled against it in a patent dispute with GlaxoSmithKline PLC (GSK.LN). The judgment related to a 2010 patent agreement between Vectura and GSK over Ellipta-branded products for lung disease and asthma. Vectura said it was disappointed by the ruling and will consider its options, including seeking permission to appeal. Vectura said it doesn’t believe the result will materially affect proceedings in the U.S. related to the same patent agreement. Shares at 1242 GMT were down 1.60 pence, or 2.2%, at 71.05 pence. We Want to Hear from You Join the conversation Comment MarketWatch Partner Center Most Popular
Topped up VEC… XXXX Went to 79p on the 8th November , but back down @ 68p today there is a court case going on . The swing is 15 %
Investors Cronicle Can anybody copy IC article to discussion
Topped up VEC… XXXXX 12 % lower then by back. 68.5p 21st March 2018