Ardana Announces a Preliminary Evaluation of Its Testosterone Cream Pivotal Study and Provides an Update on Various Strategic Options
EDINBURGH, Scotland, 13 May 2008: Ardana plc ("the Company") (LSE:ARA) the pharmaceutical company specialising in improving human reproductive health, today announces a preliminary evaluation of its Testosterone Cream in a Phase III study in hypogonadal men and provides an update on the progress of the various strategic options currently being pursued by the Company.
Both the enhanced business development activity and the M&A process being undertaken since the Company's strategic review in November 2007 have revealed that there is considerable interest in Ardana's Testosterone Cream product both as an important part of the rationale for potential M&A and as a licensing opportunity in its own right. As part of their due diligence enquiries a number of potential licensing partners recently requested an update on the multi-centre open label Phase III study.
Based on correspondence with the US Food and Drug Administration ("FDA") the expected target for patients in the eugonadal range is 75%. Whilst a substantial proportion of men who have completed the study to date have achieved average testosterone levels (Cavg) in the eugonadal range, having examined the data as part of the potential licensing of this product the Company now believes that it is unlikely that this target will be met in the current study. There was good consistency in the average testosterone levels achieved and excluding a probable protocol violator, there were no patients with excessively high average testosterone levels. The Company believes that the titration stage of the study protocol was the most likely reason that a lower than expected proportion of men were in the eugonadal range, allowing patients who should have been titrated to a higher dose to remain at lower doses.
This evaluation provides valuable input into further work for Ardana's Testosterone Cream and discussions with potential partners continue on the planning of further analyses and studies. Correspondence received from the FDA since the start of the trial has also been valuable in planning further work to clarify the optimum titration regime. The Company believes, however, that it would be prudent to assume that a further study may be required for regulatory approval of Testosterone Cream although this has not been discussed with the FDA.
Ardana's cream offers a number of potential advantages over existing gel-based products. The cosmetic-like cream consistency, low-odour and low alcohol content contribute to a potentially user-friendly preparation. The Company recently announced positive results of a differentiation study which showed that the dermal tolerability of Testosterone Cream was comparable to normal saline. Skin reactions of up to 26% have been reported on some gel preparations. The Company has also announced recently that there was no reduction in the amount of testosterone absorbed when men showered one hour following application. Most gel preparations advise avoidance of showering from 2 hours to 6 hours after application.
Further to comments made by Senetek PLC ("Senetek") on a recent investor call regarding European rights for Invicorp(tm) the Company confirms that it has received legal advice that Senetek has no right to terminate for the grounds cited and the Company is considering its options in relation to this situation.
Update on Strategic Options
Further to the announcements on 19 February and 27 March 2008 the Company continues to be in discussions with a limited number of companies which may or may not lead to an offer being made for the Company. As noted above, the Company's Testosterone Cream product has generated significant interest from both potential offerors and licensing partners and the Company is in the process of assessing precisely what the update on the Phase III trial will mean to such interested parties.
The Company continues to have discussions with potential licensing partners for a number of its products although discussions are at a relatively early stage for products other than Testosterone Cream.
The Company is in the process of finalising its Group report and accounts for the year ended 31 March 2008. However, the Company announces that as at 31 March 2008 the Group had cash and cash equivalents of ?.0 million (unaudited) and over the year to 31 March 2008 net cash used by operating activities was ?.1 million (unaudited). The Company continues to manage its cash resources prudently in light of the various restructuring initiatives that have been announced and in addition to the various M&A and licensing discussions that are ongoing the Company is also in discussions with a number of its shareholders regarding various financing options including possible bridge financing.
For more information contact:
Dr. Huw Jones. Chief Executive Officer
Tel: + 44 (0) 131 226 8550
Tel: +44 (0)20 7831 3113
Piper Jaffray Ltd.
Tel: +44 (0) 20 3142 8700
Ardana plc (LSE: ARA) is an emerging pharmaceutical company focused on the discovery, development and marketing of innovative products to improve human reproductive 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®, 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;
* StriantTM 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
* InvicorpTM, 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.ukGemma Cross Brown Assistant Financial Communications
Holborn Gate, 26 Southampton Buildings London, WC2A 1PB
T +44 (0)20 7269 7125 F +44 (0)20 7242 8695 M +44 (0)7786 074 515 www.fd.com
Posted: May 2008