The Swedish specialty pharma company,  DuoCort Pharma announced today that the Committee for Medicinal Products  for Human Use (CHMP) of the European Medicines Agency issued a positive  opinion recommending marketing authorisation of its product Plenadren, a  novel treatment for adrenal insufficiency.

Following the formal decision by the European Commission  Plenadren® can be marketed in 27 countries i.e. the European Union,  Iceland and Norway. DuoCort Pharma anticipates a final positive decision  from the Commission in the coming three months as the Commission  generally follows the advice from the CHMP.

Commenting on the  positive opinion from CHMP ,Maria Forss,CEO of DuoCort Pharma said: “We  are very pleased that the CHMP has recognized the therapeutic benefits  of Plenadren in addressing the unmet needs of the patients suffering  from adrenal insufficiency. We are also thankful for the support from  patient organizations and experts throughout the development of  Plenadren.”

Developed by DuoCort Pharma, Plenadren is a dual  release hydrocortisone replacement therapy designed to better mimic the  normal physiological cortisol serum profile in order to improve the  outcomes for patients suffering from adrenal insufficiency. Plenadren is  given as an oral tablet once daily and has an outer layer immediately  releasing hydrocortisone and an inner core releasing the rest of the  drug over the day.
Professor Gudmundur Johannsson, at the  Department of Endocrinology, Sahlgrenska University Hospital,  Gothenburg, Sweden and Chief Medical Officer of DuoCort Pharma, said:  “Plenadren is the first true innovation in over 50 years in the  treatment of adrenal insufficiency. It offers a welcomed new treatment  option to help patients lead a more normal life. Plenadren can improve  the treatment for the many of the 200 000 patients in Europe who suffer  from adrenal insufficiency who need life-long cortisol replacement  therapy for their survival.”

Although cortisol replacement  therapy for adrenal insufficiency has been available for many years  studies have recorded premature death, impaired quality of life,  increased risk of cardiovascular diseases and decreased bone mineral  density in treated patients. These data support the short-coming of  existing replacement therapies.


About adrenal insufficiency
Adrenal  insufficiency (cortisol deficiency) is a rare, life-threatening disease  that affects patients in their active years. To survive, patients  suffering from this disease need lifelong replacement therapy with  hydrocortisone. Treatment of adrenal insufficiency involves replacing,  or substituting, the hormones that the patient’s own adrenal glands are  not producing. Cortisol is replaced using hydrocortisone, the synthetic  form of cortisol.

About 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 Pharma has developed Plenadren®, an improved glucocorticoid replacement therapy for patients with adrenal  insufficiency, which is a rare disease. DuoCort Pharma has orphan drug  designations in Europe and the USA for Plenadren. Plenadren 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. The tablets come in both 5 mg and 20 mg strengths.  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.