Successful phase II/III trial of new therapy for Addison´s disease

Helsingborg Sweden/ 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-a-day hydrocortisone dosing show improved cardiovascular and metabolic measures compared to standard hydrocortisone tablets given thrice daily. The company presents the data at the 91st annual ENDO congress in Washington DC.

DuoCort’s new drug has been developed to have a physiological release profile that mimics the body´s natural secretion pattern of cortisol to improve outcomes for patients. Results from the phase II/III study in 64 patients show a physiological diurnal serum cortisol profile that resulted in significantly improved cardiovascular and metabolic profiles, with reduced body weight and blood pressure. Glucose metabolism improved, in particular in patients with diabetes mellitus. The new DuoCort therapy was safe, well accepted and well tolerated.

Endocrinology Professor and Chief Medical Officer at DuoCort, Gudmundur Johannsson says, “This new more physiological chronotherapy has excellent potential to significantly improve cortisol replacement in all types of adrenal insufficiency. The positive cardiovascular and metabolic effects and once daily therapy will make this a welcome new treatment option to help patients lead a more normal life.”

Adrenal insufficiency in its untreated state is a highly deadly condition. Current therapy is long outmoded, with no major drug improvements since at least the 1960s.

Increasing interest in adrenal insufficiency during the past 10 years has resulted in studies showing premature death, compromised quality of life, increased cardiovascular risk and reduced bone mineral density among patients with adrenal insufficiency. The likely cause is the highly un-physiological glucocorticoid replacement delivered by even the best therapy available today. The large unmet medical need is to improve therapy by mimicking the sizable diurnal variation in serum cortisol that normally occurs. DuoCort seeks to do so by providing a so-called chronotherapy with a once-a-day dosing to further enhance the physiological profile.

About Adrenal insufficiency

Patients suffering from adrenal insufficiency (cortisol deficiency) are unable to produce their own cortisol and need replacement therapy to survive. Adrenal insufficiency is a rare disease that affects patients in their active years and, 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 adrenal glands are not making. Cortisol is replaced using hydrocortisone, the synthetic form of cortisol, and sometimes with other corticosteroids.

There are different types of adrenal insufficiency: primary adrenal insufficiency also called Addison´s disease, secondary adrenal insufficiency and CAH– congenital adrenal hyperplasia.

About chronotherapy

Coordinating biological rhythms (chronobiology) with medical treatment is called chronotherapy. It takes into account the body’s biological rhythms in determining the timing–and sometimes the amount–of medication to optimize a drug’s desired effects and minimize its undesired ones.

Chronotherapy for the most part is not about new drug substances but about using medicines in new ways, better attuned to the body’s needs. Designing a drug so its release into the bloodstream has a particular release pattern or using pumps that deliver medicine at specified intervals are some of the innovations that may reap important benefits.

About DuoCort

DuoCort is a drug development company focused on improving glucocorticoid therapy in several areas of medical need. The company has its origins among researchers at the Sahlgrenska University Hospital in Gothenburg and at Uppsala University in Sweden. DuoCort is developing 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, a once daily dual-release hydrocortisone oral tablet that comes in both 5 mg and 20 mg sizes, is being developed by DuoCort Pharma AB, a wholly-owned subsidiary. For more information on DuoCort please visit www.duocort.com

For more details on the data please also see:
http://www.abstracts2view.com/endo/view.php?nu=ENDO09L_P3-614

Contact information

Medical spokesperson: Gudmundur Johannsson Tel +46 705280 872

Corporate spokesperson: Maria Forss Tel +46709670 007

P.U.L.S. erhåller 2 miljoner kronor i anslag från NUTEK

Inom ramen för NUTEKs utlysning “Pilotsatsning på privata företagsinkubatorer” erhåller P.U.L.S. AB 2 miljoner kronor för att stärka inkubatorn. Satsningen skall framförallt gå till att utvärdera nya arbetsmetoder för att finna nya projekt samt att fortsatt stärka arbetet med att stödja projektbolagen under dess tid i inkubatorn.

“Det känns mycket glädjande att som privat inkubator erhålla detta stöd från NUTEK. Stödet är en kvalitetsstämpel som visar att P.U.L.S. initiativ stöds av NUTEK.” säger Pontus Ottosson, VD på P.U.L.S. AB.

NUTEK, Verket för näringslivsutveckling, har av regeringen fått ett uppdrag att stödja privata företagsinkubatorer som en pilotsatsning. Syftet med programmet är att bredda och komplettera det befintliga och mer traditionella utbudet hos en inkubator. En annan utgångspunkt är att projekten ska kunna tillgodose behoven hos en mångfald av entreprenörer och företagare med avseende på branschinriktning, kön, etnisk bakgrund m.m.

Genom stödet från NUTEK ser P.U.L.S. stora möjligheter att utveckla nya arbetssätt för att finna medicinska behov och projektidéer, samt möjliggöra att nå en bredare målgrupp av innovatörer. Likaså ger NUTEKs anslag möjlighet att ytterligare stärka P.U.L.S. processer för stöd till projektbolagen och därigenom möjliggöra optimala förutsättningar för nya och befintliga projektbolag.

“Det är nödvändigt att erbjuda rätt kompetenser för att från början bygga in hög kvalitet i projekten och på så vis ta till vara projektens fulla potential. Efter att ha stärkt vår organisation under andra halvåret 2008 är detta ytterligare ett steg på vägen för att ge fler innovationer möjligheten att nå ut på marknaden.” säger Pontus Ottosson, VD i P.U.L.S. AB.

P.U.L.S. AB

Partners för Utvecklingsinvesteringar inom Life Sciences, P.U.L.S. AB (“PULS”) grundades 2002. PULS arbetar som inkubator och finansiär för tidiga projekt inom life science, främst läkemedelsutveckling och har hittills startat sju projektbolag. PULS består av en operativ ledning samt ett tjugotal partners med lång erfarenhet av life scienceoch har kompetens genom hela värdekedjan, från FoU till kommersialisering. PULSaffärsmodellär att tidigt engagera sig med innovatörerna för att åstadkomma en optimal IP-plattform och ett kvalitetssäkrat projekt. Genom att tillföra kapital, kunskap och kostnadseffektivitetnås detgemensamma målet attmaximera, tydliggöraoch realiseravärdetavproduktidéerna genom enframgångsrik avyttring. För mer information besök www.pulsinvest.se eller kontakta VD Pontus Ottosson på telefon 042-38 74 18.

P.U.L.S. further strengthens its project management team

Stanko Skrtic, Chief Scientific Officer, and Maria Forss, Head of business development, joined the PULS team of life sciences project management and drug development experts in mid August.

Stanko Skrtic M.D., Ph.D., M.B.A., Associate Professor in Clinical Pharmacology, has been a PULS partner for a number of years and also a founding innovator in several life sciences projects. Apart from his role as Chief Scientific Officer in PULS, he will focus on DuoCort Pharma, one of the PULS project companies that is currently in late clinical development and preparing to submit a regulatory file during 2009.

Skrtic has most recently worked at Astra Zeneca and has a background in research in experimental medicine and pharmacology at Sahlgrenska University Hospital. He is the founder and director of several biomedical start-ups. He will contribute with his broad experience in pharmaceutical development encompassing preclinical and clinical development within both SMEs and largepharmaceutical companies. Skrtic also has experience of regulatory authority work.

Maria Forss, M Sc BA, comes most recently from the global marketing organisation at AstraZeneca where she held the position of Brand Insight Director. For the last 13 years Forss has worked in both local and global marketing positions at AstraZeneca and brings a wealth of experience of early drug development from a strategic marketing perspective.

She has successfully led cross functional projects over the whole product life cycle and will broaden the competence base in PULS to secure quality in both new and existing projects. Forss is also the author of a book about quality work, “Att mäta kvalitet”.

In addition to her role as Head of business development, Maria Forss will also lead DuoCort Pharma in the lead-up to its coming market launch and partnering process.

“We are delighted to be able to strengthen the scientific and business development sides of PULS. This marks another step in our ambition to become a leading actor in investments in life science. With more personnel resources and broader expertise we can handle more project evaluations, more investments and at the same time focus the exit processes in existing project companies”, says Pontus Ottosson, CEO of PULS.


 

Partners for Development investments in Life Sciences, P.U.L.S. AB (“PULS”) was founded in 2002.

PULS acts as a investor and incubator for early projects within life science, mostly drug development and has so far started seven project companies. PULS consist of an operational management team and twenty partners with long experience in life sciences and competence through the whole value chain, from R&D to commercialisation. The business model for PULS is to engage early with innovators to attain an optimal IP platform and high quality development throughout the project. By providing capital, knowledge and cost effectivemanagement, the common objective is to maximise, clarify and realise the value of project ideas through a successful exit. For more information, please visit www.pulsinvest.se or contact CEO Pontus Ottosson on telephone +46 42 38 74 18.


DuoCort AB is developing an improved glucocorticoid replacement therapy for patients with adrenal insufficiency, an indication for which the product has orphan drug designations in Europe and the USA. A Phase II/III clinical trial is underway to assess the safety and pharmacokinetics of the product once daily compared to conventional treatment. The Phase I data presented in 2007 showed that both the product´s dual-release tablets of 5 mg and 20 mg hydrocortisone were safe and well tolerated. The drug also generated a plasma profile that better mimics the physiological cortisol release pattern than today’s available treatment. DuoCort plans to begin marketing the product in 2010. The product is being developed by DuoCort Pharma AB, a wholly-owned subsidiary.

 

About DuoCort

 

 

P.U.L.S. AB