Helsingborg June 17th 2010- The Swedish speciality pharma company DuoCort Pharma takes a step closer to the market by applying for market authorisation in EU for its new treatment for the rare and life threatening disease adrenal insufficiency, often referred to as Addison´s disease.
The application for market authorisation was submitted to the European Medicines Agency EMA via the centralised procedure. This means that an approved product will get a market authorisation valid in all EU countries plus Norway and Iceland. The process usually takes about a year.
More than 400 patients per million inhabitants suffer from adrenal insufficiency and need life long treatment to replace the hormone cortisol in order to survive.
Although replacement therapy for adrenal insufficiency has been around for a long time, several studies show premature death, impaired quality of life, increased risk of cardiovascular diseases and decreased bone mineral density in these patients. The likely cause is that today’s replacement therapy is outdated and cannot mimic the normal diurnal release profile of cortisol. The new treatment from DuoCort Pharma has a physiological release profile which mimics the body´s own natural release of cortisol. In this way, treatment outcomes are improved for patients.
Gudmundur Johannsson, Professor and senior physician at the Department of Endocrinology, Sahlgrenska University Hospital, Göteborg, Sweden and Chief Medical Officer of DuoCort Pharma, says “This new more physiological therapy has excellent potential to significantly improve cortisol replacement in all types of adrenal insufficiency. The improvement in cardiovascular risk factors combined with a simple dosing regimen will make this a welcome new treatment option to help patients lead a more normal life”
Additional data for the new product will be presented at the major annual congress of endocrinology in the USA next week.
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.
There are different types of adrenal insufficiency: primary adrenal insufficiency also called Addison´s disease, secondary adrenal insufficiency and CAH - congenital adrenal hyperplasia.
Contact information
Gudmundur Johannsson, Chief Medical Officer, tel +46 70-528 08 72
Maria Forss, CEO tel +46 70-967 00 07
Jacob Kaluski, Chairman of the Board of Directors, tel +46 70-356 56 65
Nov 07, 2011 07:00 EST The Swedish specialty pharma company, DuoCort Pharma, announced today that the European Commission has granted a European Marketing Authorisation for Plenadren® (hydrocortisone, modified release tablet), an orphan drug for treatment of adrenal insufficiency in adults, bringing these patients their first pharmaceutical innovation in over 50 years.
Oct 27, 2011 07:33 EDT DuoCort AB announces it has signed a definitive agreement to sell DuoCort Pharma AB and its orphan drug Plenadren® to the biopharmaceutical company ViroPharma Incorporated. Plenadren® is a new treatment for adrenal insufficiency, also called Addison´s disease. The total potential deal value exceeds one billion SEK of which 220 million SEK will be paid by ViroPharma on closing.
Jul 22, 2011 09:20 EDT 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.
Apr 28, 2011 01:00 EDT The Swedish specialty pharma company, DuoCort Pharma and UK-based global provider Clinigen, 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.
Jun 21, 2010 12:00 EDT DuoCort Pharma´s new physiological treatment for adrenal insufficiency improves patients’ quality of life. The company has also developed methods to optimize the dosage regimen which also contributes to an improvement in therapy over time. The Swedish pharmaceutical company presents this new data from its phase II/III trial at the 92nd annual ENDO congress in San Diego today.
Jun 29, 2009 00:30 EDT Helsingborg June 29th 2009- DuoCort publishes data from its Phase I study for the rare and life threatening disease adrenal insufficiency. The release profile of DuoCort’s new form of treatment with once-a-day hydrocortisone dosing resembles the physiological secretion pattern. The data is published today in the European Journal of Endocrinology, a leading scientific journal for endocrinology.
Jun 12, 2009 00:00 EDT Helsingborg/ Washington DC June 12th 2009- DuoCort gained promising data from its Phase II/III study for the rare and life threatening disease adrenal insufficiency. DuoCort’s new form of physiological treatment with once daily dosing show improved cardiovascular measures compared to standard hydrocortisone given thrice daily. The company presents the data at the ENDO congress in Washington DC.
Jun 27, 2008 00:30 EDT Helsingborg, Sweden, June 27, 2008 - DuoCort Pharma AB, a privately held Swedish drug development company, today announced that the US Food and Drug Administration (FDA) has granted an Orphan Drug Designation for the company's DuoCortTM hydrocortisone dual-release oral tablet in development for the treatment of adrenal insufficiency
Apr 15, 2010 10:33 EDT DuoCort has three accepted abstracts with new data at the annual congress, ENDO, arranged by the American Endocrine Society. The data that will be presented are: - Quality of life data from the ph II/III trial - Dose individualisation - A world wide patient survey with over 1200 respondents
Time: Jun 18 - Jun 21
Location:
San Diego, California, USA
Apr 14, 2010 05:38 EDT
DuoCort has developed an improved treatment for patients with adrenal insufficiency, a rare disease for which DuoCort has orphan drug designations in Europe and the USA. The new treatment is a dual release. This means it has an outer layer that immediately releases the drug and an inner core that releases the drug over the day to mimic the body´s own release of cortisol.
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