Swedish Orphan Biovitrum (Sobi), a specialty healthcare company headquartered in Stockholm, Sweden, has entered into a five-year distribution agreement with Horizon Pharma, a biopharmaceutical company headquartered in Dublin, Ireland, for two products indicated for treating urea cycle disorders (UCDs), Ravicti (glycerol phenylbutyrate) and Ammonaps (sodium phenylbutryate).

The companies will distribute Ravicti in European countries, including the UK, Germany, France, Italy, and Spain and will distributed Ammonaps in the same European countries and certain Middle Eastern countries. Under the agreement, Sobi will have exclusive marketing, sales, and distribution rights for the two medicines in the territory until December 31, 2021. Horizon has the ability to terminate the agreement after two years, subject to certain pre-defined termination fees.

Sobi currently distributes Ravicti in certain Middle Eastern countries and Ammonaps in certain European and Middle Eastern countries. It expects to launch Ravicti in Europe in 2017. Ravicti and Ammonaps are authorized by the European Commission.

Ravicti is indicated for use in all 28 member states of the European Union and three member states of the European Economic Area as a nitrogen-binding agent for chronic management of adult and pediatric patients two months of age and older with UCDs who cannot be managed by dietary protein restriction and/or amino acid supplementation alone.

Ammonaps is used to reduce levels of ammonia and glutamine in the blood and is used with other treatments and a special diet for the long-term management of patients with UCDs, where there is lack of one or more of the following enzymes: carbamyl phosphate synthetase, ornithine transcarbamylase, or argininosuccinate synthetase. Ammonaps is indicated in all patients with neonatal-onset presentation (complete enzyme deficiencies, presenting within the first 28 days of life). It is also indicated in patients with late-onset disease (partial enzyme deficiencies, presenting after the first month of life) who have a history of hyperammonaemic encephalopathy.

Source: Swedish Orphan Biovitrium