Curosurf; porcine lung surfactants
Status: approved; marketed
Organizations involved:
Chiesi Farmaceutici SpA – Manuf.; R&D; Tech.; Europe mark.
Dey L.P. – USA mark.
Merck KGaA – Parent co.
Karolinska Institute – R&D; Tech.
Ares-Serono S.A. – Europe mark.
Abbott Laboratories – Patent dispute
Nicholas Piramal – India mark.
Cross ref: See Lung Surfactant Products (entry #940).
Description: Poractant alfa or Curosurf is an aqueous formulation of purified phospholipids and hydrophobic proteins (lung surfactant) obtained post-mortem from the lungs of slaughtered pigs. Poractant alfa consists of 99% polar lipids, primarily phospholipids, and 1% hydrophobic low molecular weight proteins (SP-B and SB-C) suspended in 0.9% sodium chloride solution at a pH of 5.5-6.5.
Curosurf is available in two vial sizes, 1.5 mL (120 mg phospholipids and 1.5 mg protein) and 3 mL (240 mg phospholipids and 3 mg protein). Curosurf contains 80 mg/mL total phospholipids, including 54 mg/mL phosphatidylcholine (PC), of which about 30.5 mg/mL is dipalmitoylphosphatidylcholine (DPPC; a subfraction of PC), plus 1 (0.5-1.4) mg/mL protein, including SP-B content about 0.3 (0.2-0.4) mg/mL. Curosurf contains no preservatives, and is stored at 2-8˚C (refrigerated).
Note, derived from dead tissue, with no live organisms or bioprocessing involved, poractant alfa is not considered by this author to be a biopharmaceutical.
Nomenclature: poractant alfa [BIO FDA USAN]; poractant alpha [BAN]; Curosurf [TR]; Poractant alfa Intratracheal Suspension [FDA full]; 129069-19-8 [CAS RN]; porcine lung surfactant [SY]; 49502-180-01 and 49502-180-03 [NDC]
Companies.: Curosurf was developed and is manufactured by Chiesi Group (Parma, Italy), one of the largest Italian-owned pharmaceutical groups. Curosurf has been licensed to Dey LP, a subsidiary of Merck KGaA, for exclusive U.S. marketing by Chiesi Pharmaceuticals Inc. (Ridgefield, CT), the U.S. subsidiary of the Chiesi Group. Curosurf marked the first U.S. product approval for Chiesi. Curosurf is marketed in various European countries by Ares-Serono Group. Chiesi markets the product itself in Italy. Marketing rights in India are held by Nicholas Piramal (NPIL).
FDA class: Drug NDA
Approvals: Date = 19991118; first approval, NDA 20-744, with orphan drug designation
Date = 20020301; NDA supplement; Indication = alternative method of administering the drug through the second lumen of a dual-lumen endotracheal tube without disconnecting from the ventilator
Indications: [full text of the "INDICATIONS AND USAGE” section of product insert/labeling]:
CUROSURF is indicated for the treatment (rescue) of Respiratory Distress Syndrome (RDS) in premature infants. CUROSURF reduces mortality and pneumothoraces associated with RDS.
Medical: The standard initial dose is 2.5 mL/kg birth weight, followed by up to two doses of 1.25 mL/kg birth weight at 12 hour intervals directly into the lungs.
Status: The NDA was filed in September 1996 and approval was granted on November 18, 1999, approval time of about 38 months (~3.17 years).
Curosuf is sold in over 30 countries worldwide. It has been available in Europe since 1992, where it is the number one selling lung surfactant.
Tech. transfer: Chiesi Group (Parma, Italy) developed Curo--surf in collaboration with the Karolinska Institute (Stock-holm, Sweden). In May 2000, Abbott Labs. and Mitsubishi-Tokyo Pharmaceuticals (formerly Tokyo Tanabe Co.) filed a suit in federal court against Dey, L.P. alleging that Curosurf infringed two patents covering Survanta licensed by Abbott from the Japanese company. The suit was dismissed in May 2001.
Market: Curosurf has the highest concentration of lung surfactants among marketed products, enabling use of smaller doses. This provides a marketing advantage.
The Average Wholesale Price (AWP) is $340.70/1.5 mL vial and $667.00/3 mL vial (Red Book, 2007).
Companies involvement:
Full monograph
943 Poractant alpha
Nomenclature:
Curosurf [TR]
poractant alfa [BIO FDA USAN]
Poractant alpha Intratracheal Suspension [FDA full]
poractant alpha [BAN]
129069-19-8 [CAS RN]
lung surfactant, porcine [SY]
porcine lung surfactant [SY]
49502-180-01 and 49502-180-03 [NDC]
FDA Class: Drug NDA
Year of approval (FDA) = 1999
Date of 1st FDA approval = 19991118
(in format YYYYMMDD)
Index Terms:
lung surfactants
non-Hodgkin's lymphoma (NHL)
porcine source materials
porcine lung surfactant
dipalmitoylphosphatidylcholine (DPPC)
phospholipids
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
orphan status
EU200 Currently Approved in EU
UM001 Marketed Product in US
US200 Currently Approved in US
EM001 Marketed Product in EU
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