Thursday, April 28, 2011 - 01:00

CLINIGEN AND DUOCORT SIGN AGREEMENT NAMED PATIENT PROGRAMME FOR PLENADREN 

28 April 2011 

UK-based Clinigen, the global provider of specialist and unlicensed medicines, has signed an Agreement with Swedish speciality pharma company DuoCort Pharma, to manage a Named Patient Programme for Plenadren, a novel treatment for Addison’s disease. The product has orphan drug status in Europe and the USA and is currently in the European Union (EU) registration process for marketing authorisation. 

Although cortisol replacement therapy for adrenal insufficiency has been available for many years, several studies have recorded premature death, impaired quality of life, increased risk of cardiovascular disease and decreased bone mineral density in these patients. Existing replacement therapies, unable to mimic cortisol’s normal diurnal release profile, are viewed as the likely cause of these outcomes. 

Plenadren has been developed by DuoCort Pharma and has a physiological release profile which mimics the body’s natural release of cortisol, thereby improving treatment outcomes. 

The Agreement with DuoCort Pharma provides Named Patient Supply of Plenadren into the EU. 

Commenting on the Agreement, Mark Corbett, Clinigen’s Global Strategic Planning Director said: “We are delighted that DuoCort has selected Clinigen to manage a Named Patient Programme for Plenadren. Our team has extensive global experience of developing innovative, flexible and effective Named Patient Programmes that facilitate and address the needs of patients, health professionals and biopharmaceutical companies. We look forward to working with DuoCort”. 

“We are very pleased to be working with Clinigen who is an experienced provider of specialist medicines, enabling the access of Plenadren to meet the unmet needs for the patients with Addison´s disease.” commented Maria Forss, CEO of DuoCort Pharma. 

Clinicians and Pharmacists wishing to access Plenadren may contact Clinigen: 

T: +44 (0) 1283 494340 F: +44 (0) 1283 494341 
E: customer.services@clinigen.co.uk 

ENDS 

Notes to editor 

Clinigen 

Clinigen provides global Early Access and Named Patient Solutions. A UK-based company Clinigen develops solid, flexible and effective partnerships to facilitate and address the needs of patients, healthcare professionals and biopharmaceutical companies. 

The Clinigen Group Companies provide services throughout the entire pharmaceutical life cycle, addressing the unmet medical needs of patients by delivering unparalleled solutions. 

www.clinigen.co.uk 

DuoCort Pharma 

DuoCort Pharma is a drug development company focused on improving glucocorticoid therapy. The company has its origins among researchers at the Sahlgrenska University Hospital in Gothenburg and at Uppsala University in Sweden. DuoCort has developed an improved glucocorticoid replacement therapy for patients with adrenal insufficiency, a rare disease for which DuoCort has orphan drug designations in Europe and the USA. The new product is a once daily dual-release hydrocortisone oral tablet. It has an outer layer that releases the drug immediately and an inner core that releases the drug over the day to mimic the body’s own release profile of cortisol. The tablets come in both 5 mg and 20 mg sizes. For more information please visit www.duocort.com. 

DuoCort Pharma is a project company of the life science incubator PULS. For more information visit www.pulsinvest.se 

For further information, please contact: 

Mark Corbett, Clinigen 

T: +44 (0) 1283 494 340 
E: mark.corbett@clinigen.co.uk 

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