RDS Therapies

Curosurf® (poractant alfa), is a natural surfactant from porcine lungs. Curosurf® is a uniquely refined product as it is the only surfactant to undergo an additional liquid-gel chromatography purification, containing only polar lipids (mainly phospholidpids) and essential hydrophobic proteins SP-B and SP-C. No exogenous substances are added, as Curosurf® does not require synthetic additives for optimal function.
Curosurf® reduces the surface tension within the air spaces of the lung and thereby increases the degree of mechanical stability in the alveoli. Curosurf® has an extremely rapid absorption. Treated infants typically show an improvement in oxygenation within a few minutes. Curosurf® contains the highest available concentration of phospholipids (80mg/ml). This is of clinical importance when compared with low concentration=large volume surfactants (4-5ml/kg) that can cause complications such as hypoxia or acute airway obstruction, especially in babies on low pressure settings.

A brief history

Curosurf® a natural porcine-derived surfactant, was developed by Prof. Tore Curstedt and Prof. Bengt Robertson from the Karolinska Institute in Stockholm, Sweden. From their names the commercial name is derived:

Curstedt- Robertson Surfactant : Curosurf

Curosurf® was first tested in 10 children with severe RDS in 1983 and showed dramatic beneficial responses (Acta Paediatrica Scandinavica 1987;76:697–705 PubMed). The improvements in lung function and the lack of immunological complications provided the rationale for a large-scale clinical trials with Curosurf®. In fact, in the late eighties a multicentre trial enrolling 146 neonates, was performed. The results showed that treatment with a single dose of Curosurf®, reduced neonatal mortality by 40% and the incidence of pneumothorax by half. This study was published in 1988 and was the first to show improved survival and/or reduced BPD with surfactant therapy (Pediatrics 1988; 82:683–691 PubMed). Since then Curosurf® has become one of the most extensively studied drugs with a wide-ranging clinical development programme.

A close co-operation with Chiesi Farmaceutici S.p.A. (Italy) permitted Curosurf® to be developed on an industrial scale. In October 1992, Curosurf® was first launched in Italy, since then approximately 20,000* premature babies in Italy alone have been treated with Curosurf®.

Now, in 2006 Curosurf® is available in over 50 countries worldwide stretching from the People’s Republic of China to the United States and from South Africa to Norway. It is market leader worldwide (IMS data 2006).
In the fourteen years of commercialisation Curosurf® has been used to treat approximately 650,000* premature babies with RDS.

*(Chiesi Internal Data)