Helsingborg/ Stockholm October 27th 2010- DuoCort Pharma announces it has concluded an agreement with Recipharm under which Recipharm is set to scale-up the manufacturing of DuoCort’s tablets to commercial scale as DuoCort Pharma prepares for market entry with its orphan drug for the treatment of Addison’s disease.
The scale-up agreement represents an innovative risk sharing collaboration in which Recipharm, one of Europe’s leading pharmaceutical Contract Development and Manufacturing Organisations, will co-invest in the scale-up along with DuoCort Pharma.
The Swedish speciality pharma company, DuoCort Pharma, took a step closer to the market earlier this year when it filed for marketing authorisation in the EU for its new treatment for the rare and life threatening disease adrenal insufficiency, often referred to as Addison’s disease.
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.
“We are very pleased to be working with an organization of Recipharm’s calibre to scale-up our tablet manufacturing process. It is a real endorsement of the quality and commercial potential of our drug development that Recipharm has chosen to co-invest in this with us,” commented Maria Forss, CEO of DuoCort Pharma.
“DuoCort Pharma is an industry innovator responsible for developing a new product for patients in great need of improved medical treatment. The agreement with DuoCort Pharma fits perfectly with our business model through which the Recipharm Venture Fund invests in projects where we can make important contributions through our development and manufacturing capabilities, both in a short and long term perspective,” said Carl-Johan Spak, Executive Vice President of Recipharm.
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.
Contact information
Maria Forss, CEO, DuoCort Pharma, tel +46 70-967 00 07
Carl-Johan Spak, Recipharm, tel +46 70 88 40 154
For media enquiries, please contact Tristan Jervis or Alex Heeley at De Facto Communications on:
E-mail: t.jervis@defacto.com or a.heeley@defacto.com
Tel: +44 (0) 207 861 3019/3043
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 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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