16th Nov 2011 07:00
16 November 2011
LSE: VER
Vernalis plc: Interim Management Statement
For the period to 16 November 2011
Vernalis plc, a revenue generating development stage pharmaceutical company with one marketed product and a broad pipeline of in-house and partnered clinical programmes, today publishes its interim management statement for the period 1 July 2011 to 16 November 2011.
Key Events
·; Menarini's year-to-date frovatriptan net sales through to 30 September were, €18.4m (excluding Germany), 3% lower than equivalent net sales in the same period of 2010. Including Germany sales, total net sales were €20.5m compared to €23.8m in 2010.
·; On 20 July 2011, Vernalis announced Novartis had provided an update on the status of the Hsp90 inhibitor AUY922 at its Q2 results webcast. Novartis advised that AUY922 had been included for the first time in its selected pharmaceutical pipeline projects chart.
·; On 3 August 2011, Vernalis announced its interim results for the six month period ended 30 June 2011. The results demonstrated that the underlying financial performance was in-line with expectations and highlighted the Company's strong balance sheet.
·; On 24 August 2011, Vernalis announced it had dosed the first subjects in a Phase I trial of V81444, its adenosine A2A receptor antagonist that may help restore motor function in patients with Parkinson's Disease (PD), without the side effects commonly associated with current treatments. The study continues and results are expected in the first half of 2012.
·; On 21 September 2011, Vernalis announced it would receive a £0.3m milestone under its drug discovery collaboration with H.Lundbeck A/S.
·; On 28 September 2011, Vernalis announced positive results from its Phase I trial of V158866, its fatty acid amide hydrolase (FAAH) inhibitor, which has potential application in a wide range of pain indications as well as in other clinical indications. The results confirmed V158866 as a potent inhibitor of human FAAH and identified once daily dosing as the optimal administration regimen for future studies. Vernalis holds the worldwide rights to this programme.
·; On 3 October 2011, Vernalis announced that it had earned a €0.5m research milestone in one of its drug discovery collaborations with Servier.
·; At the half year we guided analysts to two shipments of API to be delivered to Menarini in 2011 with the expectation of three deliveries in 2012. We have recently received notification that Menarini has brought forward the order forecast for early in 2012, to the beginning of December 2011 and now anticipate three deliveries in 2011 and two deliveries in 2012.
Outlook
With continued careful cash management Vernalis has cash resources through to the end of 2013, excluding any milestones it might earn from its development pipeline and research collaborations. Vernalis remains focussed on its acquisition and in-licensing strategy to transition the Company into a diversified and self sustaining pharmaceutical company.
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Enquiries:
Vernalis Contacts
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Ian Garland, Chief Executive Officer | +44 (0) 118 989 9360 |
David Mackney, Chief Financial Officer
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Brunswick Group
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Jon Coles | +44 (0) 20 7404 5959 |
Kristin Shine
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Taylor Rafferty
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Rob Newman | +44 (0) 20 7614 2900 |
Faisal Kanth |
Notes to Editors
About Vernalis
Vernalis is revenue generating development stage pharmaceutical company with significant expertise in drug development. The Group has one marketed product, frovatriptan for the acute treatment of migraine, and eight candidates in development, seven of which are designated priority programmes. Four of these priority development programmes are currently unpartnered and three are partnered. Pipeline programmes are derived from both our own research activities where we have significant expertise in fragment and structure based drug discovery, as well as from collaborations. Our technologies, capabilities and products are endorsed by collaborations with Endo, GSK, Lundbeck, Menarini, Novartis and Servier.
Product | Indication | Pre-Clinical | Phase I | Phase II | Phase III | Marketed | Marketing Rights |
PRIORITY PROGRAMMES | |||||||
CNS Programmes | |||||||
Frovatriptan | Acute Migraine | X | Menarini & Endo Pharma | ||||
V158866 | Pain | X | Worldwide | ||||
V81444 | Parkinson's Disease | X | Worldwide | ||||
Oncology Programmes | |||||||
AUY922 | Cancer | X | Novartis | ||||
CHR2797 | Cancer | X | Chroma Therapeutics | ||||
HSP990 | Cancer | X | Novartis | ||||
V158411 | Cancer | X | Worldwide | ||||
Other Therapeutic Areas | |||||||
V85546 | Inflammatory Disease | X | Worldwide | ||||
| |||||||
LEGACY PROGRAMMES | |||||||
RPL554 | Asthma/ Allergic Rhinitis | X | Verona Pharma |
For further information about Vernalis, please visit www.vernalis.com
Vernalis Forward-Looking Statement
This news release may contain forward-looking statements that reflect the Company's current expectations regarding future events including the clinical development and regulatory clearance of the Company's products, the Company's ability to find partners for the development and commercialisation of its products, as well as the Company's future capital raising activities. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors including the success of the Company's research strategies, the applicability of the discoveries made therein, the successful and timely completion of clinical studies, the uncertainties related to the regulatory process, the ability of the Company to identify and agree beneficial terms with suitable partners for the commercialisation and/or development of its products, as well as the achievement of expected synergies from such transactions, the acceptance of frovatriptan and other products by consumers and medical professionals, the successful integration of completed mergers and acquisitions and achievement of expected synergies from such transactions, and the ability of the Company to identify and consummate suitable strategic and business combination transactions.
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