Optalyse PE Result BTG plc (LSE: BTG), the global healthcare company, highlighted the publication of OPTALYSE PE trial results in JACC: Cardiovascular Interventions. The published findings further confirm that bilateral pulmonary embolism (PE) treated in as little as 2 hours with EKOSⓇ Acoustic Pulse Thrombolysis™ therapy shows significant improvement in RV/LV ratio and with a very low one-year mortality rate of 2% and an equally low one-year recurrent PE rate of 2%. This is with considerably less tissue plasminogen activator (tPA) than used in previous studies1, as low as 8mg total. Looks like a result.
V.E.C announce Interim Results for the 6 months ended 30 June 2018, on Tuesday 11 September 2018 RNS Number : 9562U Vectura Group plc 18 July 2018 Vectura Group plc Notice of Interim Results Chippenham, UK, 18 July 2018: Vectura Group plc (LSE: VEC) (“Vectura†or the “Groupâ€), an industry-leading inhaled product formulation, device design and development business, plans to announce its Interim Results for the 6 months ended 30 June 2018 on Tuesday 11 September 2018. James Ward-Lilley, Chief Executive Officer, will host a briefing for analysts at 9.30am on the morning of the results at the offices of Numis Securities Ltd., 10 Paternoster Square, London, EC4M 7LT. A live webcast of the meeting, with the presentation slides, will be available on Vectura’s website: [link] ENDS - BE HAPPY DAVE
RNS .BTG have released an up date RNS Number : 9512U BTG PLC 18 July 2018 BTG plc: Annual General Meeting London, UK, 18 July 2018: BTG plc (LSE: BTG), the global specialist healthcare company, provides the following update ahead of its Annual General Meeting, which is being held today at 10.30am at the offices of Stephenson Harwood LLP, 1 Finsbury Circus, London EC2M 7SH. Louise Makin, BTG’s CEO, commented: "Following a strong financial performance last year in which we grew revenues 10 per cent and underlying profits 20 per cent, I am pleased to report that trading since 1 April 2018 is in line with expectations and the Board reiterates its guidance for the full year. We are now well on our way in transforming BTG into a product sales business with diverse and sustainable revenue streams and I am particularly pleased about the progress we are making in implementing our Interventional Medicine leadership strategy. There is real momentum across our portfolio and each of the core pillars of Interventional Oncology, Interventional Vascular and Pharmaceuticals continues to perform well. Our product sales business is well placed to deliver growth organically. We remain ambitious to use our significant financial resources to augment this with acquisitions to deliver on our vision of being a world leader in Interventional Medicine, transforming patient care and creating significant long-term value for shareholders." INTERVENTIONAL MEDICINE There has been significant progress in the key growth drivers of geographic expansion, indication expansion and product innovation in our oncology and vascular businesses. Oncology Geographic expansion TheraSphere® revenues grew in all geographies and another record number of patients were treated in the three months to June 2018. TheraSphere® is now sold direct in Turkey, where BTG has recently established a sales operation. Cryoablation has made a very strong start to year, particularly in the EU with the transition to direct sales in Germany, Spain and the UK. Indication expansion The EPOCH Phase III study is now more than 85% enrolled and is on track to report top-line data in 2019. EPOCH is designed to support a Premarket Approval (PMA) for TheraSphere® in the US as a second-line treatment for patients with metastatic colorectal cancer. Success would expand use of TheraSphere® into a new patient population of around 60,000 patients per year across the US and five largest EU countries combined. The STOP-HCC study of TheraSphere® in patients with hepatocellular carcinoma is now fully enrolled. It is also designed to support a PMA application in the US and is on track to report top-line data in 2019. Success would enhance the continued expansion of TheraSphere® as a treatment for patients with hepatocellular carcinoma. The SOLSTICE cryoablation study demonstrated local tumour control in 88% of patients with lung metastases while maintaining quality of life. In the MOTION cryoablation study, 61% of patients with bone metastases experienced a clinically meaningful reduction in pain and improved quality of life. These studies support the continued expansion of cryoablation into a range of cancers beyond kidney cancer and both are being prepared for formal publication. Immuno-oncology is transforming cancer treatment and there is intense research into combination treatments to improve efficacy. BTG is excited about the potential to enhance the efficacy of immuno-oncology drugs by combining them with the Company’s interventional oncology treatments. Nine grants have now been awarded in a programme with the Society of Interventional Oncology to explore this combination approach in a range of cancers. Promising first data from this programme were presented at the World Congress of Interventional Oncology in June 2018, demonstrating that local embolisation promotes a robust immune response in tumours that had few immune cells prior to treatment. BTG is also supporting a number of Investigator Initiated Studies at leading US academic hospitals exploring the combination of the Company’s interventional oncology products with marketed immuno-oncology drugs. In addition, the Company is working towards the initiation of company-sponsored clinical studies. Product innovation BTG’s investment in R&D continues to deliver new products. These include an expanded range of embolising beads such as the visible LUMI™ bead and advanced dosimetry software for TheraSphere®. New needles are being added to the cryoablation systems. One of these is a flexible needle for delivery down a bronchoscope to enhance access to lung tumours. New systems being introduced include a portable CT cryoablation system and a system that adds tumour visualisation to the ablation procedure. A new ablation modality targeting liver tumours is also under development. Vascular A good performance in Q1 FY19 reflects the continued growth of EKOS® as a treatment for pulmonary embolism (PE) in the US. European expansion continues and a direct sales team has been established in Germany. KNOCOUT PE is progressing well. This international registry study is designed to provide real world clinical and utilisation data to support further growth in EKOS® in PE across many geographies. Sales of the CentreCross®, MicroCross® and MultiCross® devices acquired from Roxwood continue to build following their transition to BTG’s vascular sales force in early 2018. June 2018 was the strongest sales month to date. Other Interventional Medicine Orders and reorders of Varithena® have continued to build month-on-month following the introduction of new CPT reimbursement codes in the US in January 2018. BTG is continuing to monitor the impact of the new codes on physician adoption and on insurer coverage and payment practice. This should be clear by the end of 2018. As announced in June 2018, an Advisory Committee Panel of the US Food & Drug Administration (FDA) voted against recommending the approval of Elevair™ (known as the PneumRx® Coils in the EU) for the treatment of people with severe emphysema. BTG anticipates that the FDA will conclude its review of the PMA application for Elevair™ in late summer 2018. PHARMACEUTICALS The Pharmaceuticals product portfolio has made a very good start to the year, benefitting from CroFab® orders at the start of the new bite season. The timing of DigiFab® expiry orders and the continued worldwide growth of Voraxaze® has also had a positive impact on sales. BTG remains confident that CroFab® is well-placed to maintain its leadership position following the potential introduction of another antivenin after October 2018. CroFab® has a broad label with a strong track record of efficacy and safety in more than 50,000 patients treated to date. BE HAPPY DAVE
Dame Louise Makin faces revolt over free shares, and the lack of new treatments To be honest I have no idea how low this can go ,as it depends on how much more bad news there is to come out ,and what the interims are like ,if BTG show another loss, then we can expect another hit I fear. This is the worst period I have witnessed in 15 years of holding this share, all we need now, is for a certain well known banker, to start selling down his holding in BTG ,to see it tank even further. There is also a fear, that this management are not on top of their game when it comes to the marketing ,and selling of BTG products through out the world ,as they are more inline with the USA markets ,than they are European or the rest of the world ,and that shows up very clearly now they have decided to show all figures in U.S dollar’s, rather than using the pound . To me it’s time the Lady stood down ,and we found a new CEO who is not so much interested in free share’s ,but more about world markets . BE HAPPY DAVE
Dame Louise Makin faces revolt over free shares, and the lack of new treatments I agree Dave. I almost feel scared to look at the share price these days. Just how far down can it go? Denis
Dame Louise Makin faces revolt over free shares, and the lack of new treatments At last the city gents are about to hold our board to account over the amount of shares board members get, this companie’s S/P has dropped to a 5 year low, yet , they still award them self’s performance related share’s, how can that be ? BE HAPPY DAVE Healthcare boss Dame Louise Makin faces revolt over finance chief pay. BTG boss Dame Louise Makin is also under pressure because of problems with new treatments. One of the most prominent bosses in the healthcare industry faces a showdown with investors over payments to her former finance director. Dame Louise Makin, chief executive of the life sciences darling BTG, is under pressure after the shareholder adviser ISS raised an alert over stock awards and bonuses due to be paid to Rolf Soderstrom, 52. He stepped down in December after a decade with the company, but he will still receive performance-based payments until next year. ISS has recommended shareholders vote against BTG’s remuneration report at its annual meeting later this month. It has also urged investors to vote against the re-election of chairman Garry Watts because of concerns over his other roles as chairman of Spire Healthcare and the estate agent Foxtons. Want to read Register with a few details to continue reading this article.
Wellstat final decision Bad news seems to be the norm these days!
Wellstat final decision so, BTG lost the appeal, hands down it looks like. But have not chosen to say anything about it. I know it is very embarrassing, but surely they should be making some kind of public statement. Maybe losing $70m has become normal for this management team, and therefore not deemed market sensitive! Delaware Law Weekly Del. Justices Uphold $70M in Damages for Failing to Market Chemo Drug | Delaware... The Delaware Supreme Court on Monday upheld a $71 million award against a Pennsylvania-based pharmaceutical company that failed to live up to its obligation to market a drug used to treat exposure to certain types of chemotherapy.
BTG and the P.E.R.T consortiumTM from the USA form a stratigic partnership PERT Consortium and BTG Form Strategic Partnership June 21, 2018 097 AM Eastern Daylight Time BOTHELL, Wash.–(BUSINESS WIRE)–BTG plc (LSE: BTG), the global healthcare company, today announced at the annual PERT ConsortiumTM Meeting in Nashville, TN, a strategic partnership with the PERT ConsortiumTM to advance the science of Pulmonary Embolism (PE) treatment and promote the implementation of PERTTM programs across the U.S. @BTG a global healthcare company, today announced at the annual #PERT2018 in Nashville, a strategic partnership with the @PERTConsortium to advance the science of #PulmonaryEmbolism treatment and promote the implementation of #PERT programs across the U.S. Tweet this In the United States, pulmonary embolism afflicts 500,000–600,000 patients annually1,2 and is either a primary or secondary cause of death in 150,000–200,000 of these individuals2. In their new partnership, BTG and the PERT ConsortiumTM are uniting to address this disease via expanding options for professional education, expanding clinical research, establishing quality benchmarks for care of PE, and developing new mobile technologies to convene PERT teams and improve decision-making. “With this partnership, we are reaffirming our long-standing commitment to improving patient care and reducing in-hospital mortality associated with Pulmonary Embolism,†said BTG Chief Medical Officer, Francis Facchini. “By partnering with the PERT ConsortiumTM, we hope to develop new strategies to transform the PE treatment paradigm.†“We applaud BTG’s commitment to research and their leadership in the field of PE,†said PERT ConsortiumTM President, Victor Tapson. “This partnership will expand the body of clinical evidence and improve multi-disciplinary decision-making for PE patients.†For the full text please go to www.businesswire.com/news/home/20180621005680/en/ BE HAPPY DAVE
CEO &CFO get bonus award as S/P declines by 30% over the past 12 months It seems no matter how bad things get here ,our management can still make a fortune for making big mistakes it makes me sick . BE HAPPY DAVE Change in Directors’ interests in the shares of BTG plc (“BTG†or the “Companyâ€) This notification is made in accordance with the Company’s obligations under the Market Abuse Regulation. The following transactions have taken place in relation to the executive directors under the Company’s share plans. 2016 Performance Share Plan On 18 June 2018, the following directors were granted conditional awards (“Awardsâ€) under the BTG Performance Share Plan 2016 (the “Planâ€). Louise Makin was granted an Award over 284,038 Ordinary Shares and Duncan Kennedy was granted an Award over 155,215 ordinary shares of 10 pence each in the Company (“Ordinary Sharesâ€). In each case the Awards were granted over Ordinary Shares equal to 225% of salary at the point of grant, calculated at 543.6p per share (being the average of the mid-market price over the five days immediately prior to the grant date). No consideration was paid for the grant of these Awards. Awards will normally vest on 18 June 2021, subject to the satisfaction of the applicable TSR and EPS based performance conditions being met over three financial years. The executive directors will then be required to hold any shares vesting (on an after-tax basis) for a further two years. Deferred Share Bonus Plan The Company has awarded bonuses to its executive directors. The bonus is paid as a mix of cash and shares, with the first 75% of salary of any bonus being paid in cash, with any bonus in excess of 75% of salary being awarded in shares under the Company’s Deferred Share Bonus Plan. For 2018 this comprises 33,992 shares for Louise Makin and 4,759 shares for Duncan Kennedy. Under the terms of the Plan these shares will normally be released in full to the directors only after a further three years’ service. Name Louise Makin Nature of the transaction bonus awards Grant of conditional awards under the Company’s Performance Share Plan 2016 Price(s) and volume(s) Price(s) £0 Volume(s) 284,038 Total COST £0 18 June 2018 Place of the transaction Outside a trading venue 2. Description of the financial instrument, type of instrument Identification code GB0001001592 Grant of awards under the Company’s Deferred Share Bonus. Price(s) and volume(s) Price(s) £0 Volume(s) –volume 33,992 Price £0 Date of the transaction 18 June 2018 Place of the transaction Outside a trading . 1 Details of the person discharging managerial responsibilities / person closely associate Duncan Kennedy Reason for the notification Position/status CFO, Director b) Initial notification /Amendments Identification code GB0001001592 Nature of the transaction Grant of conditional awards under the Company’s Performance Share Plan 2016 Price(s) and volume(s) Price(s) Volume(s) Total price. £0 155,215 £0 Aggregated volume 155,215 Date of the transaction 18 June 2018 Place of the transaction Outside a trading venue Description of the financial instrument, type of instrument Ordinary Shares of 10p Identification code GB0001001592Nature of the transaction Grant of awards under the Company’s Deferred Share Bonus Plan Price(s) and volume(s) Price(s) Volume(s £0 total allotment 4,759 £0 Aggregated allotment June 2018 Place of the transaction Outside a trading venue
FDA say no to BTG Elevairâ„¢ Endobronchial Coil System Glad you are still posting. How many other regular contributers out there are still on the new ii site?
FDA say no to BTG Elevair™ Endobronchial Coil System BTG : Result of FDA Advisory Committee vote on Elevair™ for the treatment of severe emphysema 06/15/2018 | 11:21am BST BTG plc (LSE: BTG), the global specialist healthcare company, notes that the US Food & Drug Administration’s (FDA’s) Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee yesterday voted against the approval of the Elevair™ Endobronchial Coil System for the treatment of people with severe emphysema. The Panel voted as follows: that there is reasonable assurance that Elevair™ is safe for use in patients who meet the criteria specified in the proposed indication, while considering the additional procedures needed to maintain effectiveness (7-5 in favour); that there is reasonable assurance that Elevair™ is effective for use in patients who meet the criteria specified in the proposed indication (7-5 against); and that the benefits of Elevair™ outweigh the risks for use in patients who meet the criteria specified in the proposed indication (8-3 against and one abstention). Full story to www.4-traders.com/BTG-9583552/news/BTG-Result-of-FDA-Advisory-Committee-vote-on-Elevair-TM-for-the-treatment-of-severe-emphysema-26775126/
Shar,e Price re Andy Burrows repl Should BTG not be making a statement about this? Final court ruling saying they lost the appeal with Wellstat. Wonder why they haven’t said anything about how much and when they will need to pay it? Maybe cos already provided for it? Delaware Law Weekly Del. Justices Uphold $70M in Damages for Failing to Market Chemo Drug | Delaware... The Delaware Supreme Court on Monday upheld a $71 million award against a Pennsylvania-based pharmaceutical company that failed to live up to its obligation to market a drug used to treat exposure to certain types of chemotherapy.
News Article [link]
Re: Shar,e Price re Andy Burrows repl SPIV