Navigation Links
Ikaria(R) Acquires North American Rights to LUCASSIN(R) From Orphan Therapeutics
Date:9/2/2008

- 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 arterial volume and improved renal blood flow, thereby improving renal function in patients with HRS. Terlipressin has been available outside of the U.S. for over two decades. It has been a standard of care in Europe for esophageal variceal hemorrhage in patients with liver cirrhosis, and was recently approved in France, Ireland and South Korea for the treatment of patients with HRS Type 1. Terlipressin is not approved for use in the U.S. by the FDA.

About Ikaria Holdings, Inc.

Ikaria Holdings, Inc. is a fully integrated biotherapeutics company focused on the development and commercialization of innovative pharmaceuticals, biologic messengers and drug-device combinations for hospitalized, critically ill patients. The company's lead product, INOmax(R) (nitric oxide) for inhalation, is the only FDA-approved drug for the treatment of hypoxic respiratory failure in term and near-term newborns, and also is marketed in Canada, Europe, Australia and Latin America. INOmax recently was approved for marketing in Japan. Ikaria is engaged in new and ongoing clinical development of INOmax, Covox(R) (carbon monoxide) for inhalation and hydrogen sulfide. Ikaria is headquartered in Clinton, NJ, with research facilities in Seattle, WA and Madison, WI, and a manufacturing facility in Port Allen, LA. For more information, please visit http://www.ikaria.com .

About Orphan Therapeutics, LLC

Orphan Therapeutics, LLC, is a privately held drug development company dedicated to developing treatments for rare and serious diseases. It was founded in 2003 with the initial purpose to develop and seek U.S. FDA approval for its first product, LUCASSIN(R) (terlipressin), for the treatment of hepatorenal syndrome (HRS) Type 1.

Contact:

Samina Bari

Ikaria

+1-908-238-6372

samina.bari@ikaria.com

Jason Rando

The Ruth Group on behalf of Ikaria

+1-646-536-7025

jrando@theruthgroup.com

Stephen Zoegall, Ph.D.

Berry & Company Public Relations on behalf of Orphan Therapeutics

+1-212-253-8881

szoegall@berrypr.com


'/>"/>
SOURCE Ikaria Holdings, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Ikaria(R) Strengthens Research & Development Team
2. Hoana Medical Acquires CE Mark to Expand Patient Safety Technology to European Market
3. Questex Acquires Leading Spa Industry Portal and Spa Executive Business Networking Site and Events
4. Clinix Acquires MedicWare, Inc.
5. Catholic Health East Acquires Saint Michaels Medical Center
6. Genomma Lab Internacional Acquires UNIGASTROZOL
7. Valley National Gases, LLC Acquires Beaver Valley Welding Supply, Inc: Sixth Acquisition for Valley National Gases This Fiscal Year
8. Grubb & Ellis Healthcare REIT Acquires Senior Care Portfolio 1 in Calif.
9. Vibra Healthcare Acquires two Hospitals in Southern California
10. Manhattan Scientifics Acquires Metallicum, Inc.
11. Grubb & Ellis Healthcare REIT Acquires Decatur Medical Plaza in Decatur, Ga.
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... October 13, 2017 , ... The Visiting Nurse Association (VNA) ... a collection of specialty vendors and unique items from across the nation, this holiday-themed ... and wellness services offered by the VNA. The boutique will be open Saturday, ...
(Date:10/13/2017)... ... , ... Global Healthcare Management’s 4th Annual Kids Fun Run brought out many ... event, sponsored by Global Healthcare Management’s CEO, Jon Letko, is aimed at getting kids ... of all ages; it is a non-competitive, non-timed event, which is all about having ...
(Date:10/13/2017)... ... 13, 2017 , ... Talented host, actor Rob Lowe, is ... a new episode of "Success Files," which is an award-winning educational program broadcasted ... each subject in-depth with passion and integrity. , Sciatica occurs when the sciatic ...
(Date:10/13/2017)... ... ... “The Journey: From the Mountains to the Mission Field”: the story of a missionary ... Journey: From the Mountains to the Mission Field” is the creation of published author, ... ages and currently teaches a class of ladies at her church, which she has ...
(Date:10/12/2017)... ... October 12, 2017 , ... First Healthcare Compliance ... management, will showcase a range of technology and learning solutions at the 68th ... and Expo to be held October 14–18, 2017 at the Mandalay Bay Resort ...
Breaking Medicine News(10 mins):
(Date:9/22/2017)... Md. , Sept. 22, 2017  As the ... Republican Senators Bill Cassidy (R-LA) and ... Information notes that the medical device industry is in ... medical device tax, the 2.3% excise tax on medical ... But they also want covered patients, increased visits and ...
(Date:9/19/2017)...   ZirMed Inc ., a recognized leader in cloud-based ... has been ranked #1 by its users for the seventh ... User Survey. ZirMed was recognized as the top-ranked end-to-end revenue ... centers over 200 beds and holds one of the longest ... history. ...
(Date:9/13/2017)... ATLANTA , Sept. 13, 2017   OrthoAtlanta ... to the Atlanta Football Host Committee (AFHC) for the 2018 ... Monday, Jan. 8, 2018, at Mercedes-Benz Stadium in ... part of the AFHC "I,m In" campaign, participating in many ... ...
Breaking Medicine Technology: