MPM.L Regulatory News (MPM)

14 Nov 2008 07:00



A briefing for analysts will be held at 10am on 14 November 2008 at the offices of Buchanan Communications, 45 Moorfields, London EC2Y 9AE.

MINSTER PHARMACEUTICALS PLC

("Minster" or "the Company")

Interim Results for the six months ended 30 September 2008

Minster Pharmaceuticals plc (AIM: MPM), the drug development company specialising in neurological and psychiatric disorders, is pleased to announce its results for the six months ended 30 September 2008.

Highlights in the year to date:

Positive Phase II results from tonabersat in migraine with aura, including a 68% reduction in the median number of aura attacks 

500-patient Phase IIb TEMPUS study in North America of tonabersat in the prevention of migraine fully enrolled with results anticipated in Q1 2009

Major advances in the understanding of the mode of action of tonabersat revealed in research by Dr Paul L Durham of Missouri State University

Post-tax loss of £3.48 million (H1 2007: £2.17 million loss), reflecting on-going investment in the TEMPUS study

Strong balance sheet with net cash of £9.01 million at the balance sheet date (30 September 2007: £14.48 million)

Paul Sharpe, Minster Pharmaceuticals' Chief Executive, said: "We have made considerable progress with tonabersat, our lead compound, including the recent announcement of positive results from a Phase II trial in migraine with aura. In addition, mechanistic work has shown that the compound could have utility across a wide range of neurological conditions, thereby increasing its commercial potential.

"Minster is now close to reaching one of the most important milestones in its history with the announcement in Q1 2009 of the results of our 500-patient Phase IIb TEMPUS study of tonabersat in migraine prevention. We look forward to the results of the study with optimism."

Notes for editors:

About Minster Pharmaceuticals plc

Minster Pharmaceuticals is a drug development company focussed on neurological and psychiatric disorders. Its principal pipeline assets are tonabersat, under development in the preventive treatment of migraine, and sabcomeline in schizophrenia. Worldwide rights to both compounds were acquired from GlaxoSmithKline and the compounds benefit from comprehensive safety tolerance data as a result of investment by GSK.

Tonabersat is the leading compound in an exciting new class of selective drugs designated as neuronal gap junction blockers and offers the potential to prevent the onset of migraine as a preferred alternative to acute treatment. Sabcomeline, a muscarinic partial agonist, has potential in the treatment of chronic schizophrenia.

Minster's near-term focus is on the development and commercialisation of its current pipeline. Its medium term strategy is to leverage the anticipated cashflows from the current pipeline by in-licensing further compounds with the ultimate objective of creating a substantial and highly efficient drug development enterprise focussed on the central nervous system.

Minster joined the AIM market in February 2005 and trades under the symbol MPM. For further information please visit www.minsterpharma.com . 

CHAIRMAN'S AND CHIEF EXECUTIVE'S JOINT REVIEW 

The six months to 30 September 2008 represent another period of positive progress at Minster and it is particularly pleasing to report that this progress has gained momentum post the period end with the announcement of positive Phase II trial results in our Scandinavian study of tonabersat in the treatment of migraine with aura. The positive results of this study provide considerable encouragement for the outcome of our 500-patient TEMPUS study in North America in the wider migraine population, which is due to report in the first quarter of 2009. At minimum, the migraine with aura results suggest that tonabersat has commercial potential in at least one indication and our mechanistic studies indicate that the compound could have broad utility across a wide range of neurological conditions.

Before reviewing the migraine with aura results in detail, it would be appropriate to look at the milestones achieved during the half year in bringing tonabersat, our lead compound, closer to commercialisation.

In early June we were particularly pleased to announce the appointment in the US of Joseph Lofft as a consultant to the Company. In addition to having 20 years' experience in new product development, sales and marketing in the US pharmaceutical industry, Mr Lofft has unparalleled experience of Minster's target market of migraine prevention in that he launched and oversaw the growth of Johnson & Johnson's Topamax in the prevention of migraine. Topamax, which has achieved annual sales estimated at more than $1 billion, is about to become a generic compound, creating the opportunity for the next generation of treatment in tonabersat.

Mr Lofft has responsibility for management of activities ongoing in the US to support the announcement in the first quarter of 2009 of the results of the TEMPUS study. He is also working with other members of the management team on a programme designed to enhance the profile of Minster in the US.

When Minster acquired tonabersat from GlaxoSmithKline in 2001, the compound, a small molecule, came with significant preclinical and clinical data. However, at that time there was limited understanding of the compound's mode of action, which, in collaboration with academic partners, we have been seeking to elucidate.

Dr Paul L Durham, an Associate Professor at Missouri State University, presented his latest research into the mode of action of tonabersat at the 50th Annual Scientific Meeting of the American Headache Society (AHS) in Boston, Massachusetts, in June. His findings represented a major advance in the understanding of tonabersat, which is the leader in a new class of compounds called neuronal gap junction blockers.

This mechanistic research shows that tonabersat has the ability to modulate communication via gap junctions between nerve cells and glial cells, which suggests significant commercial potential as abnormal activity at these gap junctions is believed to underlie a range of neurological conditions including migraine, neuropathic pain and epilepsy. 

Much of our focus during the period was on the Phase IIb TEMPUS trial of tonabersat in migraine prevention. Recruitment progressed well during the period and full enrollment was achieved during June. The results of this trial are on schedule to be announced in the first quarter of 2009.

Post the period end, we announced positive results from the tonabersat trial in the prevention of migraine with aura conducted by Professor Jes Olesen at the University of Copenhagen. The median number of aura attacks was reduced by 68% in patients receiving tonabersat when compared with placebo. This result in the primary endpoint of the study is both clinically and statistically highly significant. Commenting on the results, Prof Olesen, the trial's lead investigator and Director of the Danish Headache Centre, said: "This is the first time in more than 30 years that a drug designed specifically for migraine prevention shows significant efficacy."

It is expected that the detailed results of the trial will be published in due course by Prof Olesen`s group in a peer-reviewed article in a leading international journal.

Migraine with aura affects around 30% of migraine sufferers and is a type of migraine in which the headache is preceded by symptoms such as visual disturbances and abnormalities of speech and hearing. These aura symptoms are generally recognised as being difficult to treat with existing medications.

The results of this Phase II trial are extremely exciting for your Company. It demonstrates again that tonabersat is a well tolerated compound and clearly has therapeutic value, a result that was suggested in our Phase IIa trial but, until now, had not been confirmed.

Financial results

The unaudited loss after taxation for the six months ended 30 September 2008 amounted to £3,478,875 (2007: £2,169,663) and is in line with management's expectations. 

The Group's cash and cash equivalents at 30 September 2008 amounted to £9,010,000 (2007: £14,484,000). The cash outflow primarily reflects the costs of the TEMPUS study, which will be completed around the turn of the year and therefore will require only limited further investment. 

Minster has a low-cost, virtual business model and, on current plans, is fully funded until the middle of 2010 by which time, subject to a successful outcome of the TEMPUS study, we aim to have in place a licensing deal for the commercialisation of tonabersat.

Outlook

The outlook for Minster remains exciting and full of promise. A TEMPUS trial result in the first quarter of 2009 that confirms tonabersat as efficacious in the prevention of migraine and well tolerated would put the compound on track for the final stages of commercial development through out-licensing to a pharmaceutical company with the expertise and resources to take it through the registration process.

The prevention of migraine is a very large market with annual sales currently in excess of $1billion in the US alone and one in which there is a clear requirement for a next-generation preventive product. 

Following the result of the TEMPUS trial we expect to accelerate our development work on our other promising compound, sabcomeline. Development in the management of schizophrenia continues to support and enhance our expectations for a viable role for sabcomeline as a treatment for this difficult and serious condition.

Our low-cost business model means that we remain well-funded and, with major newsflow imminent, we look forward to the future with confidence.

14 November 2008

  Unaudited Consolidated Income Statement

For the six months ending 30 September 2008

  Unaudited Consolidated Statement of Changes in Equity

For the six months ending 30 September 2008

Unaudited Consolidated Balance Sheet

At 30 September 2008

  Unaudited Consolidated Cash Flow Statement

For the six months ending 30 September 2008

  Notes to the Interim Report

The calculation of loss per share is based on the following information:

The calculation of the loss per share is based on the loss after taxation and the average of the ordinary shares of 5p in issue during the period. 

For the diluted loss per share, the average number of ordinary shares in issue is adjusted to assume conversion of all dilutive potential ordinary shares. The Group has share options, warrants and shares to be issued as secondary consideration in respect of the subsidiary acquired during the period ended 31 March 2005 as potentially dilutive.

  Independent Review Report to Minster Pharmaceuticals plc

We have been engaged by the Company to review the condensed consolidated financial statements in the Interim Report for the six months ended 30 September 2008, which comprises the consolidated income statement, consolidated statement of changes in equity, consolidated balance sheet, consolidated cashflow statement and related notes. We have read the other information contained in the Interim Report and considered whether it contains any apparent misstatements or material inconsistencies with the information in the condensed consolidated financial statements.

This report is made solely to the Company in accordance with guidance contained in International Standard on Review Engagements 2410 (UK and Ireland) 'Review of Interim Financial Information Performed by the Independent Auditor of the Entity' issued by the Auditing Practices Board. To the fullest extent permitted by law, we do not accept or assume responsibility to anyone other than the Company for our work, for this report, or for the conclusions we have formed.

Directors' responsibilities

The Interim Report, including the condensed consolidated financial statements contained herein, is the responsibility of, and has been approved by, the directors.

As disclosed in note 2, the annual financial statements of the Group are prepared in accordance with IFRS as adopted by the European Union. The financial information in this Interim Report has been prepared in accordance with International Accounting Standard 34 'Interim Financial Reporting' as adopted by the European Union.

Our responsibility

Our responsibility is to express to the Company a conclusion on the condensed consolidated financial statements in the Interim Report based on our review.

Scope of review

We conducted our review in accordance with International Standard on Review Engagements (UK and Ireland) 2410 'Review of Interim Financial Information Performed by the Independent Auditor of the Entity' issued by the Auditing Practices Board for use in the United Kingdom. A review of interim financial information consists of making enquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures. A review is substantially less in scope than an audit conducted in accordance with International Standards on Auditing (UK and Ireland) and consequently does not enable us to obtain assurance that we would become aware of all significant matters that might be identified in an audit. Accordingly, we do not express an audit opinion.

Conclusion

Based on our review, nothing has come to our attention that causes us to believe that the condensed consolidated financial statements in the Interim Report for the six months ended 30 September 2008 are not prepared, in all material respects, in accordance with International Accounting Standard 34 as adopted by the European Union.

PETERS ELWORTHY & MOORE

Cambridge

14 November 2008