Press Release

DuoCort Pharma and Clinigen sign agreement on named patient programme for Plenadren

Apr 28, 2011 01:00 EDT
DuoCort Pharma and Clinigen sign agreement on named patient programme for Plenadren

Helsingborg/ Burton on Trent April 28th 2011– The Swedish specialty pharma company, DuoCort Pharma and UK-based Clinigen, the global provider of specialist and unlicensed medicines,  announce that they have concluded an agreement whereby Clinigen will manage a Named Patient Programme for Plenadren, a novel treatment for Addison´s disease. The product has orphan 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 around for a long time, several studies have recorded premature death, impaired quality of life, increased risk of cardiovascular diseases and decreased bone mineral density in these patients. Existing replacement therapies, unable to mimic cortisol’s normal diurnal release profiles, are viewed as the likely cause of these outcomes. The new treatment from DuoCort Pharma 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, regulatory authorities and biopharmaceutical companies.  We look forward to working with DuoCort”.

“We are very pleased to be working with Clinigen who are 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

 
About Adrenal insufficiency

Patients suffering from adrenal insufficiency (cortisol deficiency) are unable to produce their own cortisol. To survive, they need replacement therapy with hydrocortisone. Adrenal insufficiency is a rare disease that affects patients in their active years.  Because it is a chronic condition, they require this life-saving therapy throughout their lives. Treatment of adrenal insufficiency involves replacing, or substituting, the hormones that the patient’s own adrenal glands are not making. Cortisol is replaced using hydrocortisone, the synthetic form of cortisol. 


For further information, please contact:

Greg Batcheller, DuoCort  

T  +46 46 288 50 08                                 E: greg.batcheller@duocort.com

Mark Corbett, Clinigen

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

Louise Blakeborough, Chapter Five

T: + 44 (0) 1306 731800                          E: lblakeborough@chapterfive.co.uk

Attached Files

Categorization

Topics:
Pharmacy,
Research,
Medicine,
Medicine, Pharmacepticals,
Medical research
Tags:
addisons disease,
duocort,
plenadren,
orphan drug,
clinigen,
puls

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