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 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, visit www.duocort.com.
DuoCort Pharma is a project company of the life science incubator PULS. For more information, visit www.pulsinvest.se.
Recipharm AB is a leading contract development and manufacturing organisation based in Sweden with 2,000 employees. The company operates 12 development and manufacturing facilities in Sweden, France, the UK, Spain and Germany and is headquartered near Stockholm. Recipharm supplies the global pharmaceuticals market with hundreds of different products in most dosage forms, including solid dose, granulates, powders, sterile liquids and lyophilisates, semisolids, beta-lactams, hormones, and inhalers. For more information, visit www.recipharm.com
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.
SOURCE: DuoCort Pharma