Discovery Laboratories Inc, a late-stage specialty pharmaceutical company leveraging its technology in humanized lung surfactants to develop novel respiratory therapies and pulmonary drug delivery products, announced the issuance of European Patent No. 59006. The patent covers claims directed to compositions that contain the peptide KL4 (sinapultide) and related KL peptides for use as a therapeutic surfactant for treating respiratory distress syndrome and related conditions. Discovery's humanized surfactant technology platform and its lead product Surfaxin, are based on KL4's proprietary peptide engineered to mimic human pulmonary surfactant.

Surfactants are protein/lipid compositions that are produced naturally in the lungs and are critical to breathing. There are four known surfactant proteins, of these four, surfactant protein B (SP-B) has been found to be the most important and essential to proper respiratory function. The KL4 peptide, the subject of Discovery's newly-issued patent, has been engineered to be an exact mimic of human SP-B.

"Surfactant replacement therapy has potential to address life threatening disorders and large pharmaceutical market opportunities," said Robert J. Capetola, President and CEO. "This surfactant therapy has only been in existence for approximately ten years and is in its embryonic stage in traditional medical and pharmaceutical industry terms. Currently available animal- derived products were approved in the 1990's, but because of the limitations of these products, they are only applied to one indication. This patent is the newest addition to our broad portfolio consisting of over 30 issued or pending patents worldwide, protecting our composition of matter, utility, manufacturing and process technologies. Our extensive patent portfolio, as well as the Orphan Drug designation of Surfaxin for several indications, positions us to be the leader in surfactant technology for respiratory therapies in critical care markets as well as for use in broad non-critical care, and ambulatory applications, involving potentially several billion dollar markets."

A lack or deficiency of surfactant is associated with several severe respiratory diseases including acute lung injury, acute respiratory distress syndrome, severe asthma and chronic obstructive pulmonary disease. Currently available animal-derived surfactants have been effective in treating premature infants that lack surfactant, but several drawbacks and limitations of these products such as a lack of protein, inconsistency of product quality, limited supply, and high manufacturing cost make it difficult to treat other respiratory diseases. Presently, Discovery is developing the only humanized, engineered version of natural human lung surfactant for the treatment of respiratory diseases that can be produced economically in large quantities as a high quality pharmaceutical without risk of potential transmission of animal-borne diseases or adverse immunological reactions.