STOCKHOLM, SWEDEN--(Marketwire - January 13, 2012) - 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.
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.
Sobi press release Jan 13, 2012 in pdf format: http://hugin.info/134557/R/1577290/491823.pdf
This announcement is distributed by Thomson Reuters on behalf of Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and other applicable laws; and
(ii) they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Swedish Orphan Biovitrum AB (publ) via Thomson Reuters ONE
[HUG#1577290]
For further information, please contact:
Asa Stenqvist
Head of Communications and Investor Relations
Tel.: +46 8 697 21 88
