Sobi submits application for Orfadin® oral suspension to EMA
(Thomson Reuters ONE) -
Swedish Orphan Biovitrum AB (publ) (Sobi) announced today that the company's
application for Orfadin oral suspension has been validated by the European
Medicines Agency (EMA). This new dosage form has been developed to facilitate
the ease and accuracy in administration of the desired Orfadin dose to
paediatric patients and to increase convenience for the patients and their
caregivers.
"We are glad that our application for the Orfadin oral suspension has been
accepted by EMA", said Birgitte Volck, Senior Vice President and Chief Medical
Officer at Sobi. "The liquid formulation of Orfadin will facilitate precise
dosing for children and should also help increase adherence which is key in any
successful treatment."
The oral suspension is included in a Paediatric Investigation Plan (PIP) agreed
with EMA in March 2012.
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About Orfadin
Orfadin is used for the treatment of hereditary tyrosinemia 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.
For more information - not for publication
Media relations Investor relations
Oskar Bosson, Head of Jörgen Winroth, Vice President, Head of Investor
Communications Relations
T: +46 70 410 71 80 T: +1 347-224-0819, +1 212-579-0506, +46 8 697 2135
oskar.bosson(at)sobi.com jorgen.winroth(at)sobi.com
Sobi submits application for Orfadin® oral suspension to EMA:
http://hugin.info/134557/R/1724303/574744.pdf
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Source: Swedish Orphan Biovitrum AB (publ) via Thomson Reuters ONE
[HUG#1724303]
Unternehmensinformation / Kurzprofil:
Datum: 22.08.2013 - 08:01 Uhr
Sprache: Deutsch
News-ID 290003
Anzahl Zeichen: 3107
contact information:
Town:
Stockholm
Kategorie:
Business News
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"Sobi submits application for Orfadin® oral suspension to EMA"
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