Ardana Bioscience Ltd.

Ardana is an emerging pharmaceutical company focused on the discovery, development and marketing of innovative products to improve human reproductive health, in order to address the areas of considerable unmet needs in this $25 billion-plus market.

Since Ardana’s foundation in July 2000 we have pursued a four-part strategy to create value from the business by:

  • Maintaining a broad and balanced portfolio to manage risk, focusing on the therapeutic area of human reproductive health;

  • Actively pursuing an in-licensing and acquisition programme for products and technologies to maintain a robust pipeline, including near-term commercial products and potential high value development candidates;

  • Retaining value in our portfolio by building a sales and marketing capability in leading European markets, through both our own infrastructure and partnerships; and

  • Maintaining a lean organisation by selective outsourcing in order to achieve flexibility.

Ardana operates a fully integrated pharmaceutical business model from research right through to sales and marketing.  Its experienced management team operates a virtual model in the areas of research, development (both pre clinical and clinical), manufacturing, regulatory and logistics using validated out-sourced suppliers to complete the work programmes designed internally.  Ardana has its own salesforce in the UK and marketing partners in Europe.

Currently Ardana’s key customers are endocrinologists and urologists and, as the portfolio expands, the customer profile will include other reproductive health specialists such as obstetricians and gynaecologists.  These are small, well-defined groups of clinicians easily addressed by a small team of sales representatives..

Ardana has rapidly established a broad and risk balanced product portfolio following  a series of research collaborations, licensing agreements, strategic product and company acquisitions.  This portfolio includes:

  • 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

  • Striant™ 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;

  • Invicorp ®, an injectable combination drug treatment for erectile dysfunction, for which Ardana has marketing and manufacturing rights in Europe;

  • Teverelix, a long acting formulation of a GnRH antagonist that provides dose-dependent control of the release of sex hormones such as testosterone in men and oestrogen in women.  Teverelix is in phase II development in two indications, prostate cancer and benign prostatic hyperplasia, and in phase I development in endometriosis.

  • ARD-07 Oral GHS,  an oral growth hormone secretagogue currently in a pivotal registration study for the diagnosis of growth hormone deficiency in adults, and in early clinical development in a first therapeutic indication.

  • Testosterone cream,  a transdermal testosterone delivery system in phase III development for the treatment of male hypogonadism and phase I development for a female indication.

In addition, Ardana has a strong portfolio of follow-on products in development.

Ardana also has exclusive rights to commercialise research developed by the Medical Research Council (MRC) Human Reproductive Sciences Unit (HRSU) in Edinburgh, Scotland. The HRSU is recognised by the World Health Organisation as one of the leading academic centres of excellence in reproductive biology in the world.  In addition it has research agreements with the Universities of Manchester and Montreal.

Ardana listed on the Main Board of the London Stock Exchange in March 2005. Stock ticker is ARA-L.  The company is led by a strong management team which has previous senior management experience within global pharmaceutical companies including Pharmacia, Wellcome, Merck, Aventis and Pfizer.


News

 

Edinburgh, UK: 9 April 2008 :  Ardana plc (LSE:ARA) today announces preliminary results from a Phase II repeat dose study of its lead development compound, the GnRH antagonist Teverelix LA (Long-Acting), in patients with prostate cancer demonstrating testosterone suppression for 28 weeks using an alternative formulation for the first time.

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Edinburgh, UK, 27 March 2008: Ardana plc (“Ardana” or the “Company”) (LSE:ARA) the pharmaceutical company specialising in improving human reproductive health, today provides an update to shareholders on developments in relation to the proposed sale or merger of the Company (the “Process”), as announced on 19 February 2008.

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Edinburgh, UK, 18 March 2008: Ardana plc (LSE:ARA) today announces positive results of its Testosterone Cream in a Phase I study to evaluate the absorption of testosterone in women from their unique cream formulation.

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Edinburgh, UK, February 28, 2008: Ardana plc (LSE:ARA), in conformity with the Transparency Directive’s transitional provision 6, today notifies the market of the following:

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Edinburgh, UK, February 19, 2008: Ardana plc (LSE:ARA), is today issuing its third quarter Interim Management Statement (“IMS”) and provides an update on the business.  more> >

Edinburgh, UK, February 19, 2008: Ardana plc (LSE:ARA), today announces that it is seeking to sell or merge the Company in order that the value of its pipeline can be maximised.  Piper Jaffray Ltd. has been appointed to advise the Company in connection with this process. more> >

Edinburgh, UK, January 9, 2008: Ardana today announces the positive outcome of a pre-

Investigational New Drug (IND) meeting with the United States Food and Drug Administration (FDA) for the development of its lead compound Teverelix LA (long-acting) for the treatment of endometriosis

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