Swedish Orphan Biovitrum AB (publ) (Sobi) announced today its decision to
withdraw the company's New Drug Application for an oral suspension of Orfadin in
the US. The decision to withdraw the current application is based on a request
for further information by the US Food and Drug Administration (FDA) regarding
the usability by the intended user population of the Orfadin oral suspension and
the oral syringe to be included in the package.
Sobi will discuss a re-submission date for the Orfadin oral suspension with the
FDA in Q1 2014.
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About Orfadin
Orfadin is used for the treatment of hereditary Tyrosinaemia type 1 (HT-1), a
rare genetic disorder which can cause liver failure, kidney dysfunction and
neurological problems.
About Sobi
Sobi is an international specialty healthcare company dedicated to rare
diseases. Our mission is to develop and deliver innovative therapies and
services to improve the lives of patients. The product portfolio is primarily
focused on inflammation and genetic diseases, with three late stage biological
development projects within haemophilia and neonatology. We also market a
portfolio of specialty and rare disease products for partner companies. Sobi is
a pioneer in biotechnology with world-class capabilities in protein biochemistry
and biologics manufacturing. In 2012, Sobi had total revenues of SEK 1.9 billion
(€ 215 M) and about 500 employees. The share (STO: SOBI) is listed on NASDAQ OMX
Stockholm. More information is available at www.sobi.com
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