UK LAUNCH FOR ARDANA’S STRIANT™ SR TESTOSTERONE REPLACEMENT THERAPY FOR MEN WITH PRIMARY OR SECONDARY HYPOGONADISM

Ardana Ltd, the emerging pharmaceutical company dedicated to better reproductive health, announces the UK launch of Striant™ SR, a testosterone replacement therapy for men with primary or secondary hypogonadism.

Striant™ SR is the first mucoadhesive buccal (gum surface) testosterone replacement therapy for primary or secondary male hypogonadism. The novel formulation is a discreet therapy, which delivers consistent, controlled and sustained levels of mean serum total testosterone that approximate the physiological levels seen in healthy young men (10.4-36.4 nmol/L ; 3.0-10.5ng/mL)*1-3. In Phase III studies 87%-97% of patients achieved average testosterone levels within the physiological range over a 24 hour dosing period.*1,2, 3

Dr Maureen Lindsay, Ardana Chief Executive Officer, said ‘We are very excited about the introduction of Striant™ SR in the UK. This novel delivery system gives clinicians a new therapy option. We believe the properties of Striant™ SR provide a number of benefits and our highly trained sales force is well equipped to support clinicians as they adopt this innovative product’.

Striant™ SR is presented as 30 mg off-white, monoconvex circular tablets, which are applied to the gum twice daily (bd) at twelve hour intervals eg once in the morning and once in the evening. The tablet adheres to the buccal mucosa in the small natural depression in the mouth above the incisor tooth. As it is exposed to saliva, Striant™ SR softens into a gel-like form, which is designed to remain in place for a 12 hour dosing period, after which it is removed and replaced. The product delivers testosterone through the gum and cheek surfaces that are in contact with the tablet and directly into the bloodstream, avoiding first pass liver metabolism.

Striant™ SR is well tolerated *1-3. The most common adverse event attributed to the drug was application site irritation, which was reported by 3.9% of patients*4. Gum related side effects were usually transient and mild or moderate in intensity.

Striant™ SR is available in a single strength, so no dose titration is required. A month’s supply costs £45.84 for a pack of 60 tablets.

Male Hypogonadism (which is characterised by testosterone levels below the normal range) can be caused by conditions affecting the testes, pituitary gland or hypothalamus gland, or by a genetic disorder. Signs and symptoms of male hypogonadism can include decreased libido (sexual desire), erectile dysfunction, fatigue, depression, reduced muscle mass and osteoporosis. Testosterone replacement therapy is designed to provide and maintain normal levels of testosterone. Alternative therapies include injectable formulations of testosterone, oral preparations, transdermal patches, topical gels and subcutaneous implants.

Ardana acquired key European rights to Striant™ SR from the US pharmaceutical company Columbia Laboratories Inc (NASDAQ CBRX) in October 2002. Ardana has rights to market Striant™ SR in 18 European countries and Columbia is initiating the mutual recognition process aimed at obtaining approval in other member states of the EU.

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