Ikaria acquires NDA and IND for Lucassin from Orphan Thera

USA-headquartered Ikaria Holdings says that it has acquired the New Drug Application (NDA) and the Investigational New Drug (IND) application to Lucassin (terlipressin for injection) from Orphan Therapeutics, assuming all future development and ownership of the drug in North America and Australia. Lucassin being developed for the treatment of hepatorenal syndrome (HRS) Type 1, an orphan-designated condition for which there currently are no approved drugs in the USA.

In August 2008, Ikaria acquired the North American rights to Lucassin, including responsibility for manufacturing, distribution, marketing, sales, customer service and post-market development. Those rights, along with the NDA, were to be transferred to Ikaria following marketing approval. In November 2009, Orphan Therapeutics received a complete response to its marketing application from the US Food and Drug Administration, citing the need for an additional clinical trial.

"Ownership of the development process for Lucassin will allow us to leverage our deep clinical insight, experience in conducting critical care trials, and understanding of the pathophysiology of this complex condition to progress its development in order to seek marketing approval in the USA," commented Daniel Tasse, chairman and chief execurive of Ikaria.