- No Currently Approved Drugs to Treat Hepatorenal Syndrome Type 1 in U.S.
CLINTON, N.J. and LEBANON, N.J., Sept. 2 /PRNewswire/ -- Ikaria Holdings, Inc. and Orphan Therapeutics, LLC announced today that they have entered into an agreement under which Ikaria has acquired rights to LUCASSIN(R) (terlipressin) in North America from Orphan Therapeutics.
Orphan Therapeutics has initiated a rolling NDA with the U.S. Food and Drug Administration (FDA) seeking marketing approval for LUCASSIN for the treatment of hepatorenal syndrome (HRS) Type 1. LUCASSIN has been granted orphan drug status and fast-track designation. Following marketing approval of LUCASSIN, Orphan Therapeutics will transfer North American rights to Ikaria, which will then be responsible for its post-market development and commercialization.
HRS Type 1 is the development of kidney failure in patients with late-stage liver cirrhosis in the absence of any other cause. It is characterized by rapid onset of renal failure with a high mortality rate that exceeds 80% within three months.
"The acquisition of LUCASSIN reinforces our corporate mission to deliver novel treatments in areas of unmet medical need within the underserved critical care market," commented Daniel Tasse, President and CEO of Ikaria. "We look forward to working with Orphan Therapeutics to provide a promising therapy to patients with this life-threatening condition."
"Ikaria's focus on therapies for patients in critical care makes it an ideal partner for LUCASSIN," said Peter Teuber, Ph.D., President of Orphan Therapeutics. "We are very pleased to be working with Ikaria towards our goal to make LUCASSIN available for HRS Type 1 patients in the U.S., who currently have no approved drugs available to them."
LUCASSIN is a synthetic vasopressin analogue that acts via the
vasopressin V1 receptor as a systemic vasoconstrictor, which appears to
increase effective ar
|SOURCE Ikaria Holdings, Inc.|
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