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Albireo Receives Positive Opinion for Orphan Drug Designation for A4250 for Severe Liver Diseases
Date:7/24/2012

GOTHENBURG, Sweden, July 24, 2012 /PRNewswire/ --

Albireo AB (Gothenburg, Sweden; "Albireo"), a biopharmaceutical company specializing in gastroenterology, today announced that the European Medicines Agency Committee for Orphan Medicinal Products (COMP) has issued a positive opinion on an application for orphan medicinal product status for the company's lead hepatology candidate, A4250, for the treatment of:

  • Primary Biliary Cirrhosis (PBC)
  • Progressive Familial Intrahepatic Cholestasis (PFIC)
  • Alagille Syndrome

The positive opinion of the COMP has now been forwarded to the EU commission for final approval. The designation would allow Albireo ten years of marketing exclusivity in EU member countries after obtaining market authorization, as well as streamlined regulatory review processes and registration.

"We are very pleased with the EMA´s recognition of our technology with A4250 as an orphan medicinal product for the treatment of these liver diseases in Europe", said Dr. Hans Graffner, Chief Medical officer at Albireo. "This designation is an important milestone in our efforts to provide a treatment for patients with cholestatic liver diseases; a disease entity often leading to severe symptoms, liver transplantation and with reduced survival. A4250 is an inhibitor of the bile acid transport mechanism and will decrease the toxic levels of bile acids in the liver cells."

About Primary Biliary Cirrhosis (PBC)

PBC is a slowly progressive autoimmune disease of the liver, primarily affecting women; average age when symptoms start is around 40-50 years of age. It is characterized by destruction of bile ducts resulting in an increased bile acid concentration in the liver inducing inflammation and cirrhosis. There are more than 100.000 patients with PBC in Europe. Main symptoms are fatigue, severe itching and symptoms of cirrhosis. There is no cure for PBC, some thera
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SOURCE Albireo AB
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