Pipeline

Ardana has rapidly built up a balanced portfolio of marketed, in-clinic and research-stage products through strategic acquisitions and licensing agreements plus efficient clinical development and support of research programmes in certain selected academic centre of excellence.

Products

1 Emselex®:  Ardana has recently reached agreement with Novartis Pharmaceuticals UK Limited to be granted the sole and exclusive rights to launch   and promote Emselex®  (darifenacin hydrobromide) for symptoms of Overactive Bladder (OAB) in the UK for a ten year term.  Emselex was launched in the UK in November 2006.

Emselex® is an oral once-daily muscarinic M3 selective receptor antagonist (M3 SRA) for the symptomatic treatment of OAB. Symptoms of OAB include urinary urgency (a sudden and compelling desire to pass urine, which is difficult to defer) with, or without, urge urinary incontinence (involuntary leakage accompanied or immediately preceded by urgency), usually with frequency (voiding the bladder too often), and nocturia (waking at night one or more times to void the bladder).

Antimuscarinic drugs are often used to treat patients who present with symptoms of OAB, although other therapies such as bladder retraining may also be efffective.

Emselex® works by selectively inhibiting the M3 receptor, the primary mediator of bladder (detrusor) contraction, whilst relatively sparing the M1 and M2 receptors that are located in various body organs, including the brain and heart. Emselex® has been shown to significantly reduce the number of episodes of urge incontinence and urgency as well as reducing the frequency of micturition. The most commonly reported side effects were dry mouth and constipation, but discontinuation from treatment due to these adverse events was infrequent.

Pooled data from Phase III studies showed that the incidence of cardiovascular adverse events for Emselex® was low. Furthermore, a study in elderly healthy volunteers indicated that Emselex® did not significantly impair memory function.

 

2 Striant™ SR: a testosterone replacement therapy for male hypogonadism (confirmed by clinical features and biochemical tests), Striant™ SR was first launched in the UK in June 2004 in the UK with subsequent roll-out into other European territories thereafter.

Striant™ SR is a novel and innovative mucoadhesive buccal (gum surface) testosterone replacement therapy for male hypogonadism. 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. It is the most common hormone deficiency in men, occurring in five men in every 1,000 (Source: Wu:1996). The UK Endocrine Society estimates that one in 20 of hypogonadal men receives treatment. 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 in October 2004, Columbia completed the European Mutual Recognition Procedure for the product and received a positive opinion from all major markets including Germany, France, Spain, Portugal, Italy and the Scandinavian countries.

3 Invicorp®: an intracavernosal injectable combination of phentolamine mesilate and vasoactive intestinal polypeptide for the treatment of  male erectile dysfunction has been approved in Denmark, and Ardana is planning to seek national marketing approvals throughout Europe via the Mutual Recognition Procedure.