New drug for prostate cancer

Plenaxis® (abarelix) is our lead product. It is the first in a new class of hormonal products to treat advanced and metastatic prostate cancer.

Plenaxis® is a gonadotrophin-releasing hormone receptor (GnRH) blocker and it works by direct blockade of the GnRH receptors, resulting in a rapid and sustained reduction in testosterone levels and rapid and sustained disease control. As a result, Plenaxis® is the first antagonist hormonal for managing prostate cancer that overcomes the need for anti-androgen co-prescribing. It has a rapid onset and offset of action, leading to fast and profound PSA and prostate volume reduction.

Clinical studies have shown that no hormonal surge or clinical flare occurs with Plenaxis® (unlike with agonist hormonal therapy), the efficacy is equal to the combined use of an agonist and anti-androgen and the effects on testosterone are reversible on stopping treatment.

Plenaxis® is available in Germany and roll out across Europe is planned following the approval of the drug in eleven additional EU Countries in August 2010.

Further information is available on request.

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Treatment for bladder cancer

Mitem® (mitomycin) is an injectable mitomycin product used either on its own or in combination with other therapies in the treatment of a range of cancers.

Most notably, Mitem is given intravesically (into the bladder) for the treatment of bladder cancer. Mitem® is currently sold in Germany. SEP acquired the product in October 2010 and took over German distribution shortly thereafter. The Company plans to introduce the product into other European markets once marketing authorisations are granted.

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Regurin® XL (prolonged release trospium chloride) is a new, once daily version of Regurin®. It is one of a group of medicines called ‘anticholinergics’.

Regurin XL is indicated to help control the symptoms of overactive bladder that cause a frequent need to go to the toilet (urinary frequency), needing to suddenly rush to the toilet (urgency) and/or not getting there in time (urge incontinence).

Trospium chloride is one of the anticholinergics approved by NICE for the treatment of urinary incontinence in women.

Further information on Regurin XL

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Click here if you are a patient or other non-healthcare professional

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Regurin (trospium chloride) is available in packs of 60 tablets and is used twice daily to treat the symptoms of overactive bladder

Further information on Regurin

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Both Regurin XL and Regurin are available in the UK as prescription-only medicines.

Regurin is also available on prescription in Ireland.

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Haemopressin® (terlipressin) is a critical care product for the treatment of bleeding oesophageal varices.

Speciality European Pharma sold the worldwide right to Haemopressin® to IS Pharma plc (formerly Maelor plc) in 2008, enabling the Company to focus its corporate resources on developing its urology franchise. Distribution rights for Haemopressin® in France and Italy were retained by SEP as part of the sale. Since January 2010 the Company has distributed Haemopressin® in France and Italy via tender participation.

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