verona pharma plc (VNAPF) Key Developments
Verona Pharma plc Provides Earnings Guidance for the Year Ended December 31, 2014; Provides Update on RPL554 Development Programme
Mar 3 15
Verona Pharma plc provided earnings guidance for the year ended December 31, 2014. The company expects to report a slightly lower than expected loss before tax of approximately £3.7 million for the year ended 31 December 2014. The loss reflects slightly lower than expected expenditure on R&D and slightly lower expenditure than expected on general and administrative costs. Costs associated with expansion of the senior management team and board only incurred towards the end of the year.
The company provided update on RPL554 Development Programme. The company is fully focused on developing RPL554 and in January this year announced that the first subjects had successfully been dosed in the initial clinical trial with its new proprietary and commercially scalable nebulized formulation of RPL554. The initial clinical trials are designed to prepare RPL554 for the treatment of acute exacerbations of chronic obstructive pulmonary disease (COPD). The board remains excited by the prospects for RPL554 as it advances further into development in 2015. Following a thorough review of the planned development and associated expenditure for RPL554, the board has concluded that it is now timely to accelerate the work on the drug to progress to the start of phase IIb clinical trials in 2016. Therefore, gross R&D expense to be incurred in 2015 will be substantially greater than previously expected. The higher R&D spending in 2015 essentially results from moving work forward from 2016 into the current year.
Verona Pharma plc Announces First Patients Dosed with New Formulation of RPL554
Jan 12 15
Verona Pharma plc announced that a first cohort of healthy volunteers have been successfully dosed with a new proprietary, nebulised formulation of RPL554. These volunteers are part of a combined Phase I/II clinical trial profiling this new RPL554 formulation. The trial includes a single ascending dose study in healthy volunteers and 5 days multiple ascending dose study in both healthy volunteers and patients with COPD (chronic obstructive pulmonary disease). The primary objective of the study is to confirm safety, tolerability and bronchodilation with this new formulation. Up to 120 subjects are planned to be recruited to this study and the results are expected to be available in the second half of 2015. Verona Pharma is initially developing RPL554 as a nebulised treatment for acute exacerbations in COPD patients in a hospital or home-care setting. Phase II studies to date with the drug, a novel PDE3/4 inhibitor, have been conducted in over 100 subjects. Results collectively show that the drug is a very potent bronchodilator with the ability to illicit a unique anti-inflammatory response. At the doses tested, RPL554 had a benign side effect profile, which compared favourably with existing standard treatments. The original nebulised formulation of the drug used in these initial studies was devised to provide proof-of-concept data, before developing a new formulation suitable for commercial scale-up. The new proprietary formulation of RPL554 has demonstrated very attractive properties, in addition to being viable for commercial scale-up. In pre-clinical testing, inhalation of this new formulation was better tolerated, producing significantly less irritation than the one used previously. It is expected that this will result in a significantly improved therapeutic index in patients, implying that they should be able to inhale higher doses over a shorter time interval, improving convenience and potentially compliance.
Verona Pharma plc Presents at 7th annual Biotech Showcase Conference 2015, Jan-13-2015 04:30 PM
Dec 18 14
Verona Pharma plc Presents at 7th annual Biotech Showcase Conference 2015, Jan-13-2015 04:30 PM. Venue: Parc 55 Wyndham San, Francisco - Union Square, San Francisco, CA 94102, United States. Speakers: Sven Jan-Anders Karlsson, Chief Executive Officer and Executive Director.
Verona Pharma plc Appoints Kenneth Newman as Chief Medical Officer, Effective January 1, 2015; Announces Incorporation of Verona Pharma, Inc
Dec 17 14
Verona Pharma plc announced the appointment of Kenneth Newman, M.D., M.B.A. to the newly created position of Chief Medical Officer, with effective from 1 January 2015. Dr. Newman will be based in the US and provide his expertise to support the company's global activities. Dr. Newman is an experienced pharmaceutical and biotechnology industry executive with extensive leadership experience in clinical development, including a number of orally inhaled drugs for the treatment of respiratory disease. Dr. Newman will join Verona Pharma from Mesoblast Inc, where he was Chief Development Officer and Head of Global Clinical Development. The appointment and the creation of the US affiliate reflects the continuing focus of Verona Pharma on advancing the clinical development and commercialization of its lead pipeline drug, RPL554, a first-in-class PDE3/PDE4 inhibitor currently in phase II development for the treatment of chronic obstructive pulmonary disease (COPD) and asthma.
The company also announced the incorporation of its fully owned subsidiary, Verona Pharma Inc.
Verona Pharma plc Announces Executive Changes, Effective Dec. 1, 2014
Nov 24 14
Verona Pharma plc announced the appointment of David Raymond Ebsworth as Non-Executive Chairman of the Board of Directors with effect from December 1. Ebsworth will succeed Clive Page, who has held the role since founding the company in 2006. Ebsworth has been involved in successful product approvals in the US and Europe. From October 2009 to August 2014, Ebsworth served as Chief Executive Officer of Vifor Pharma. He was also named as CEO of Galenica AG in 2011. Ebsworth had worked for over 19 years in Bayer AG.