Verona Pharma PLC Verona Pharma: 2015 in review

 
TIDMVRP 
 
Verona Pharma plc 
 
                      ("Verona Pharma" or the "Company") 
 
         2015 in review - A successful year with significant progress 
 
21 March 2016, Cardiff - Verona Pharma plc (AIM: VRP.L), the drug development 
company focused on first-in-class medicines to treat respiratory diseases, 
today provides a summary review of its 2015 performance. 
 
Primary goals in 2015 were centred around initiating and completing a series of 
clinical trials on its drug candidate, RPL554, using the Company's new 
proprietary nebulised suspension formulation. RPL554 is a novel inhaled PDE3/ 
PDE4 inhibitor with both bronchodilator and anti-inflammatory properties, 
currently in development as a nebulised treatment for acute exacerbations in 
chronic obstructive pulmonary disease (COPD) patients in a hospital or 
home-care setting. 
 
Commenting on progress, CEO Jan-Anders Karlsson said: 
 
"At the time of our 2014 fund raise we laid out our plans for further 
development of RPL554, initially to address severe COPD. Based on the strength 
of the emerging clinical data, we decided in early 2015 to accelerate this 
development plan. 
 
"To date almost 300 subjects have been included in clinical trials with RPL554. 
Collectively these data consistently highlight that the drug is an effective 
bronchodilator and has a broad anti-inflammatory profile. Importantly, it is 
well-tolerated over a wide dose range and adverse events are similar to those 
in subjects treated with placebo. 
 
"Having made marked clinical progress with RPL554, we are currently considering 
all options for further funding of our development programmes. As part of this 
process, and as previously stated, the Company recognises that the right 
commercial partner could bring significant value to the development of RPL554 
for chronic maintenance treatment in COPD and perhaps asthma.  Verona Pharma 
therefore continues to be involved in business development discussions around 
the RPL554 programme." 
 
2015 Highlights 
 
  * Initiation and successful completion of a Single Ascending Dose (SAD) and 
    Multiple Ascending Dose (MAD) Phase I/II trial in 112 healthy volunteers 
    and COPD patients using the new suspension formulation of RPL554 
 
  * Initiation and successful completion of a dose-finding Phase IIa study in 
    29 patients with chronic persistent asthma in comparison to salbutamol and 
    placebo1 
 
  * Initiation and end of clinical stage of Phase IIa study in 30 COPD patients 
    in which RPL554 was administered on top of standard of care 
    bronchodilators; results expected in Q2 2016 
 
  * Board of Directors strengthened by appointment of Dr Anders Ullman and Dr 
    Ken Cunningham, two physicians highly experienced in the development of 
    respiratory medicines 
 
  * Loss before tax expected at approximately GBP8.9m for the year ended 31 
    December 2015 (2014:GBP2.8m), broadly in line with market expectations, 
    reflecting tight cost control despite the planned increase in R&D spend, 
    especially on clinical studies 
 
  * Cash balance (unaudited) at 31 December 2015 was GBP 3.5 million (2014: GBP 
    10.0); Clinical activity is expected to be at a lower level in 2016 than in 
    2015 as the Company plans the next tranche of clinical studies. Thus the 
    Board believes the Company has sufficient capital to progress RPL554 to the 
    start of Phase IIb clinical trials, earmarked to begin around the end of 
    2016. 
 
Marked Clinical Progress with RPL554 
 
During 2015 the Company made excellent progress in developing the new 
proprietary nebulised suspension formulation of RPL554. The clinical studies 
which completed in 2015, the results of which have since been reported, exposed 
this new formulation to healthy volunteers, and to COPD and asthma patients. 
Results consistently showed that the product has a pharmacokinetic profile 
which permits twice-daily dosing, and that it elicits a profound dose dependant 
bronchodilator response. There was also an absence of serious adverse events. 
Additionally, the clinical segment of a Phase II study examining nebulised 
RPL554 as an add-on treatment to standard bronchodilators such as ipratropium 
and salbutamol was also completed during 2015 and we expect top line data to be 
available in Q2 2016. Three presentations of some of the results of these 
studies will be made at the American Thoracic Society meeting in San Francisco 
in mid May 2016. 
 
The Company is highly encouraged by the results demonstrated with this new 
formulation of RPL554 and is preparing plans to progress this formulation into 
a Phase IIb clinical programme to investigate treatment of acute exacerbations 
in COPD. The nebuliser bronchodilator market was estimated to be worth about $1 
billion in 2014 in the US.2  The Company is also planning additional 
pre-clinical and clinical work in Cystic Fibrosis and potentially other 
respiratory conditions. 
 
Board of Directors Further Strengthened During the Year 
 
The Company also significantly strengthened the Board of Directors during the 
year. Dr Anders Ullman, who joined the Board in September 2015, was previously 
Chief Medical Officer at Nycomed (now Takeda) and was responsible for the 
development and approval of roflumilast (Daxas®) which was approved for the 
treatment of COPD. He also oversaw the initiation of a post-approval Phase IV 
study (the REACT study) which was published in the Lancet in February 2015. 
This study demonstrated that treatment with the PDE4 Inhibitor roflumilast 
leads to a 24% reduction in severe COPD exacerbations even in the presence of 
"double" or "triple" therapy. Subsequently AstraZeneca purchased the global 
commercial rights to roflumilast from Takeda. 
 
Dr Ken Cunningham, who also joined the Board in September, was the CEO of 
Arakis, a respiratory company sold to Sosei. He was also a former CEO of 
Skyepharma plc, which developed the orally inhaled drug flutiform®, which is 
approved in Europe and Japan for the treatment of asthma and licensed to 
Mundipharma. Ken was also chairman of Prosonix, an inhalation development 
company, purchased by Circassia in 2015. 
 
By adding Dr Ullman and Dr Cunningham to the Board we have significantly 
expanded the expertise on the Board both in terms of respiratory medicine and 
significant transaction experience. 
 
References 
 
1 Results were reported in a press release, 15 March 2016 (post period end) 
 
2 IMS Consulting Group market research 2014 
 
For further information, please contact: 
 
Verona Pharma plc                      Tel: +44 (0) 20 7863 3300 
 
Jan-Anders Karlsson, CEO 
 
N+1 Singer                             Tel: +44 (0)20 7496 3000 
 
Aubrey Powell / Jen Boorer 
 
FTI Consulting                         Tel: +44 (0)20 3727 1000 
 
Simon Conway / Julia Phillips 
 
About Verona Pharma plc 
 
Verona Pharma plc is a UK-based clinical stage biopharmaceutical company 
focused on the development of innovative prescription medicines to treat 
respiratory diseases with significant unmet medical needs, such as chronic 
obstructive pulmonary disease (COPD), asthma and cystic fibrosis. 
 
Verona Pharma's lead drug, RPL554, is a first-in-class drug currently in Phase 
2 trials as a nebulised treatment for acute exacerbations of COPD in the 
hospital setting.  The drug is a dual phosphodiesterase (PDE) 3/4 inhibitor and 
therefore has both bronchodilator and anti-inflammatory effects, which are 
essential to the improvement of patients with COPD and asthma. 
 
Verona Pharma is also building a broader portfolio of RPL554-containing 
products to maximise its benefit to patients and its value.  This includes the 
very significant markets for COPD and asthma maintenance therapy.  In addition, 
the Company is exploring the potential of the drug in different diseases, such 
as cystic fibrosis, where it is in pre-clinical testing and has received a 
Venture and Innovation Award from the UK Cystic Fibrosis Trust. 
 
 
 
END
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