Sobi signs global licensing agreement for novel neonatology treatment from Only for Children Pharmaceuticals
Sobi has signed a global licensing agreement with the French company Only for
Children Pharmaceuticals (O4CP) regarding bumetanide reformulated for treatment
of diuresis and seizures in neonates. The new drug is currently in clinical
phase II under the EU financed NEMO project. The first market authorization of
the product is expected in 2014.
O4CP will be responsible for obtaining market authorizations and for
manufacturing of drug product. Sobi will be accountable for the
commercialization of the product on a global basis. The agreement includes an
upfront payment by Sobi in the amount of 300 000 Euro and potential future
milestones of a value up to approximately 1.7 million Euro. O4CP will also
receive royalties on future commercial sales.
"We are pleased to enter into this partnership with O4CP to further the
development of an important potential therapy for neonates. Sobi is committed to
innovations in the pediatric and neonatal areas where there remains a high
degree of unmet need for medicines specifically developed for these patients.
The partnership with O4CP around bumetanide is an important step for us and will
provide a perfect complement to Kiobrina® in the future," says Geoffrey
McDonough, CEO of Sobi.
"Sobi understands the value of bringing medicines to neglected populations. The
company has a strong market organization and global ambitions, and is therefore
a perfect partner for us. The agreement will secure that this important
treatment for neonates will reach the market," says Vincent Grek, President of
O4CP.
About seizures in neonates and NEMO
Neonatal seizures occur in 2-3/1000 births and are a major cause of both acute
mortality and long-term neurodisability. Better treatments for neonatal seizures
have been identified as a high priority for research by several international
expert groups with the ultimate aim to improve long-term outcome.
The NEMO project is part of the EU Framework Program 7 (FP7) NEMO stands for
Treatment of NEonatal seizures with Medication Off-patent. The aim with the
project is to develop an effective antiepileptic drug regimen suitable for
treatment of neonates with birth asphyxia using innovative strategies targeted
specifically to the needs and peculiarities of babies. The focus on this high
risk group is justified because of the poor neurodevelopmental outcome for
babies with seizures which are resistant to current anti-epileptic drugs. A
European-wide multicentre approach would for the first time allow the
performance of a randomized controlled trial with enough statistical power in
this age-group. More information is available at www.nemo-europe.com.
About Only for Children Pharmaceuticals (O4CP)
O4CP is a French pharmaceutical company based in Paris focusing on the
development of new medicines for children. Currently, O4CP has 11 drugs in
development in cancer (European FP7 Project LOULLA&PHILLA), immunology (French
Project Forms4Kids), neonatology (European FP7 Projects NEMO and TINN2) and
world medicines (French Project Forms4kids). More information is available
atwww.o4cp.com.
For further information, please contact:
Åsa Stenqvist, Head of Communications and Investor Relations
Tel.: +46 8 697 21 88
Swedish Orphan Biovitrum (Sobi)
Sobi is a leading integrated biopharmaceutical company dedicated to bringing
innovative therapies and services to improve the health of rare disease patients
and their families. The product portfolio comprises about 60 marketed products
as well as projects in the late clinical phase. Key therapeutic areas are
Inflammation and Genetics & Metabolism. In 2010 Sobi had revenues of SEK 1.9
billion and around 500 employees. The share (STO: SOBI) is listed on OMX NASDAQ
Stockholm. More information is available atwww.sobi.com.
The information above has been published pursuant to the Swedish Securities
Market Act and/or the Financial Instruments Trading Act. The information was
released for public distribution on 13 January 2012 at 08.30 a.m. CET.