U.S. Patent and Trademark Office publishes patent for neonatal jaundice. web site jaundice in newborns

Gastroenterology Week December 27, 2004 2004 DEC 27 – (NewsRx.com & NewsRx.net) — WellSpring Pharmaceutical Corporation announced that the U.S. Patent and Trademark Office (USPTO) has awarded a patent for a novel synthetic method of preparation for stannsoporfin (Stanate), a new drug being developed for the treatment of jaundice in newborns.

This patent (U.S. 6,818,763 B2) grants exclusive rights to WellSpring for this novel and cost-effective method of synthesis. The process involves fewer steps, increased yields and lower costs. Foreign patent equivalents have also been filed.

A second patent for water-soluble stannsoporfin analogs (a composition of matter patent) has also been submitted to the USPTO. This second patent is under regulatory review and has been previously published. The new stannsoporfin analogs covered by this patent may be suitable for either oral or parenteral administration. Review of this second patent is ongoing. Foreign equivalents have also been filed.

Stanate is an investigational drug in late stage development being studied for the treatment of neonatal jaundice and prevention of kernicterus, a form of cerebral palsy. Kernicterus (a form of brain damage) is attributed to high levels of bilirubin, a byproduct of heme metabolism. Bilirubin is a bile pigment, which is normally eliminated from the body after conversion into a water-soluble form by the liver. Newborns often temporarily lack the necessary liver maturity to eliminate bilirubin and require several days to develop this capability.

Neonatal jaundice is normally a transient phenomenon, but left untreated in more severe forms can result in irreversible brain damage. About 60% of babies readmitted to the hospital after well baby discharges are readmitted for treatment of jaundice.

Stanate is an enzyme inhibitor which blocks the conversion of heme into bilirubin for a few days, which is normally sufficient time for the baby’s liver to mature and facilitate bilirubin’s excretion. The use of Stanate may obviate the need for other medical intervention and protects the infant from the possibility of brain damage. The national incidence of kernicterus and cerebral palsy has been reported to be on the rise. Stanate is given by injection.

The second patent is a composition of matter patent for a series of water- soluble metalloporphyrin analogs of stannsoporfin that can be given by oral administration. Both patents, when issued, will provide 20 years of coverage for WellSpring. go to website jaundice in newborns

WellSpring acquired exclusive worldwide rights to the drug from Rockefeller University. U.S. rights to Stanate have been granted to InfaCare Pharmaceutical Corporation.

WellSpring is a privately held pharmaceutical company that manufactures and sells Dyrenium, a potassium sparing diuretic which is used to manage congestive heart failure and the edema associated with certain liver diseases.