Aura Renew Acq Regulatory News (ARA)

19 Feb 2008 07:01

Ardana PLC19 February 2008 Ardana plc INTERIM MANAGEMENT STATEMENT THREE MONTHS ENDED 31 DECEMBER 2007 Edinburgh, UK, February 19, 2008: Ardana plc (LSE:ARA), the emergingpharmaceutical company focused on the discovery, development and marketing ofinnovative products to improve human reproductive health, is today issuing itsthird quarter Interim Management Statement ("IMS") and provides an update on thebusiness. This IMS has been produced solely to provide additional informationto shareholders as a body to meet the relevant requirements of the UK ListingAuthority's Disclosure and Transparency Rules. It should not be relied upon byany other party or for any other purpose. This IMS relates to the three month period from 1 October 2007 to 31 December2007 and contains information that covers this period and the period from 1January 2008 up to the publication of this IMS ("the period"), unless otherwisespecified. Ardana has announced today in a separate press release that: • it is seeking to sell or merge the Company and Piper Jaffray Ltd. has been appointed to advise in connection with this process; and • it has put in place a restructuring programme to reduce the Company's cash commitments. PROPOSED SALE OR MERGER OF THE COMPANY In December 2007 the Company announced the results of a strategic review as aresult of which the Board has directed the Company's efforts and resources onthe high-value, nearer term opportunities in Ardana's pipeline, such asTeverelix LA and Testosterone Cream. Ardana has reported positive clinicalresults in both these product candidates during the period and believes thatthey both have substantial commercial potential. Partnering discussionscontinue on the co-development of Teverelix LA and for the co-development andcommercialisation of Testosterone Cream in the USA. Interest has also beenexpressed for other assets within the Company's portfolio of clinical products. Following the strategic review announcement Ardana has had consultations withits major shareholders to explore the options available to the Company torealise increased value for its pipeline. As a result of these discussions andthe prevailing market conditions, the Board has concluded that shareholder valueis more likely to be maximised through seeking a sale or merger partner whichwill be better placed to fund the Company's extensive clinical developmentportfolio. RESTRUCTURING Ardana also announces a restructuring of the business to reduce the Company'scash commitments and enhance the Company's position in future discussions withpotential sale or merger partners. The Company operates a 'virtual' businessmodel which has resulted in a low cost base such that most activity and cost isborne by the research and clinical development programmes. The specific impactof the restructuring on the Company's clinical programme and the Company as awhole are summarised as follows: • Teverelix LA: the current Phase II programmes in prostate cancer and BPH have now been completed and positive preliminary results were announced in the period; further planned development programmes will not be initiated; and • Testosterone Cream: a Phase III study in the USA commenced in 2007 and enrolment is now complete. In addition, differentiation studies, from which positive preliminary results were announced at the end of last year, will be completed. Further activity is on hold. All other development, manufacturing, commercial and overhead activities will bescaled back or halted bearing in mind the Company's contractual obligations,reducing both cash commitments and headcount. PIPELINE UPDATE IN THIRD QUARTER The Company continued to invest in the product development pipeline during thethird quarter and product candidates continued to advance to plan. TEVERELIX LA • Teverelix LA, continues to progress well and we announced positive Phase II results in prostate cancer and BPH as well as the positive outcome of a pre-IND meeting in the third indication of endometriosis. • In September 2007 data were announced in prostate cancer demonstrating a new dose regimen extended to 8 weeks from 4 weeks. This important data underlines the commercial potential for Teverelix LA in prostate cancer; • Data announced in November 2007 in BPH shows that patients may only need to have two maintenance doses per year for symptomatic treatment. The Company believes that this may represent significant potential improvement over current treatments; • In the third indication of endometriosis, the positive outcome of a pre-Investigational New Drug (IND) meeting with the FDA was recently announced allowing the clinical development path for Teverelix LA in this indication to be agreed. TESTOSTERONE CREAM • A Phase III study in the USA for Testosterone Cream, our transdermal delivery of testosterone for the treatment of male hypogonadism, commenced in the period and the enrolment target total of 130 testosterone deficient men into the study has now been reached. After an initial titration period where the correct dose level for the patient is established, patients will then receive Testosterone Cream daily for three months. Results from the study are expected in the second half of 2008. • In addition two Phase I studies to support the development of Testosterone Cream were reported during the period. In the first, a study to determine the dermal tolerability of the cream, low irritant potential was identified as a characteristic of patient use. This is an important factor for user-friendliness. The second study measured the effect of showering post application on absorption of testosterone using the cream. Preliminary analysis showed no detrimental effect on the absorption of testosterone if a patient showers as early as one hour after drug application when compared to drug application with no subsequent showering. • These supplementary studies indicate a potential advantage for Testosterone Cream in terms of patient acceptability. ORAL GHS A pivotal Phase III registration study of the oral formulation of the Company'sgrowth hormone secretagogue (GHS) is ongoing, for the diagnosis of growthhormone deficiency. MARKETED PRODUCTS Revenues from the sale of the marketed products, Striant(TM) SR, Invicorp(TM) and Emselex(R) are growing but are not considered material to the results of thebusiness at present. CASH Net cash used by operating activities in the business for the nine month periodto 31 December 2007 was £10.4 million (nine months to 31 December 2006: £9.7million). Cash and cash equivalents as at 31 December 2007 was £6.6 million (31 December2006: £19.2 million). Cash and cash equivalents as at the latest month end being31 January 2008 was £6.1 million (31 January 2007: £17.4 million). Chief Executive's comments Ardana's Chief Executive, Dr Huw Jones said "Ardana's key strength is itsportfolio. We are pleased with the progress of our compounds in development andwe continue to add value to our key assets which we believe will havesignificant commercial advantages in their respective markets. Successfulexecution of our strategy to sell or merge the Company, announced separatelytoday, will enable the potential in the pipeline to be maximized." For more information contact: Ardana plc Financial DynamicsDr. Huw Jones. Chief Executive Officer Julia PhillipsTel: + 44 (0) 131 226 8550 Emma Thompson Tel: +44 (0)20 7831 3113 Ardana plc (LSE: ARA) is an emerging pharmaceutical company focused on thediscovery, development and marketing of innovative products to improve humanreproductive health, a $25.5 billion market. Ardana's lead products are summarised below: • Teverelix LA, in development for three initial indications (prostate cancer, benign prostatic hyperplasia and endometriosis); • ARD-0705 a growth hormone secretagogue in Phase III for the diagnosis of growth hormone deficiency in adults; • Testosterone Cream, a transdermal testosterone delivery system in development for the treatment of male hypogonadism, in Phase III trials; • Emselex(R), a once a day treatment for the symptoms of overactive bladder syndrome, which Ardana has exclusive UK marketing and promotion rights and is being distributed in collaboration with Novartis UK Limited; • Striant(TM) SR, a testosterone replacement therapy that has been launched by Ardana through its own sales force in the UK and through marketing partners in certain European countries, as a treatment for men with confirmed hypogonadism; and • Invicorp(TM), an injectable combination drug treatment for erectile dysfunction, for which Ardana has marketing and manufacturing rights in Europe and has been launched in Denmark. For further information please see www.ardana.co.uk This information is provided by RNS The company news service from the London Stock Exchange