Orphan Therapeutics, LLC is a privately held drug development company. It was founded in 2003 with the purpose to develop and seek regulatory approval for its first product, LUCASSIN® (terlipressin), for the treatment of Hepatorenal Syndrome (HRS) type 1 in the US, Canada, Japan and Australia.
Teuber,Ph.D. (Founder & President) has more than 25 years of experience in the pharmaceutical industry (Hoffmann-La Roche, The Medicines Company) and a proven track record of developing successful specialty pharmaceuticals (Xeloda®, Angiomax®).
History: Peter and his small team of experienced drug development professionals have been working towards their goal of making Lucassin available to HRS 1 patients in the US and other countries from the US IND filing (2004) through the completion of the phase III study OT-0401 (Sanyal 2008) and the rolling New Drug Application (NDA) for Lucassin® in May 2009. Following the FDA complete response letter to its NDA, citing the need for an additional clinical trial, Orphan Therapeutics sold the NDA and its development rights for Lucassin® in North America and Australia to its Commercialization Partner Ikaria Inc. in March 2010. Orphan Therapeutics still has a continued commitment to assist the Ikaria team through the FDA approval process for Lucassin®.
In November 2010, Ikaria announced the enrollment of the first HRS type 1 patient into its Phase III trial for Lucassin® known as the REVERSE trial. In April 2012, Ikaria announced that Lucassin® (terlipressin) has been approved in Australia.
For more information please refer to IN THE NEWS, ikaria.com and ikariaaust.com.
(Sanyal 2008): Sanyal AJ, Boyer TD, Garcia-Tsao G, Regenstein F, Rossaro L, Appenrodt B, Blei A, Gülberg V, Sigal S, Teuber P and the Terlipressin Study Group. A randomized, prospective, double-blind, placebo controlled trial of terlipressin for type 1 hepatorenal syndrome. Gastroenterology. 2008;134:1360-1368.