Date: 2012-01-13
Type of information: Licensing agreement
Compound: bumetanide
Company: Swedish Orphan Biovitrum SOBI (Sweden), Only for Children Pharmaceuticals (O4CP) (France)
Therapeutic area: CNS diseases
Type agreement: licensing
Action mechanism:
Disease: diuresis and seizures in neonates
Details: 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 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.
Financial terms: The agreement includes an upfront payment by Sobi in the amount of € 300 000 and potential future milestones of a value up to approximately € 1.7 million. O4CP will also receive royalties on future commercial sales.
Latest news:
