DuoCort seeks European market authorisation for orphan drug
- Details
- Published on Wednesday, 16 June 2010 13:32
Helsingborg - 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is that today's replacement therapy is outdated and cannot mimic the normal diurnal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.
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.
DuoCort Pharma AB is a project company of the
life science incubator PULS. For more information
visit www.pulsinvest.se.
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
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