September 2, 2008
Ikaria® Acquires North American Rights to Lucassin® from Orphan Therapeutics
No Currently Approved Drugs to Treat Hepatorenal Syndrome Type 1 in U.S.
Ikaria Holdings, Inc. and Orphan Therapeutics, LLC announced today that they have entered into an agreement under which Ikaria has acquired rights to LUCASSIN® (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. Read more...
May
28, 2008
Orphan
Therapeutics Announces Initiation of Rolling NDA Submission for LUCASSIN® (terlipressin) for the Treatment of Hepatorenal Syndrome Type 1
Orphan Therapeutics today announced that it has begun
submission of the rolling LUCASSIN® (terlipressin) New Drug Application (NDA) for the
treatment of Hepatorenal Syndrome (HRS) type 1 in patients with late-stage liver cirrhosis.
LUCASSIN® had previously been granted orphan status and fast track designation for this
indication by the U.S. Food and Drug Administration (FDA). Currently no drug is approved in
the U.S. to treat HRS type 1, a rare and life-threatening condition in late-stage liver disease. Read
more...
November
4, 2007
Five (5) Terlipressin Abstracts Presented at AASLD 2007 and ASN 2007
Four terlipressin abstracts were presented at AASLD. Abstract #737 presented prognostic factors for HRS reversal based on results from the clinical trial OT-0401. This poster was selected as a Presidential Poster of Distinction representing the top 10% of all abstracts at AASLD. The other 3 abstracts (#742, #815 and LB13) were from independent authors, investigating terlipressin.
Another terlipressin abstract and poster was presented at the American Society of Nephrology 2007 meeting examining terlipressin effect on creatinine clearance as calculated from OT-0401 data.
December
18, 2006
Orphan
Therapeutics Announces Rolling NDA Submission for
LUCASSIN™ (terlipressin) to Treat Type 1 Hepatorenal Syndome
Orphan
Therapeutics announced today plans to initiate a rolling submission in the second
quarter of 2007 for a New Drug Application (NDA) with the FDA to commercialize
LUCASSIN™ (terlipressin), its drug candidate for treating type 1 hepatorenal
syndrome (HRS)....The rolling submission process enables companies that have
been granted fast track designation by the FDA to submit sections of the NDA
to the
agency as they become available. The FDA grants fast track status to drug candidates
that treat serious or life-threatening conditions, and that demonstrate the potential
to address unmet medical needs. Terlipressin received fast track status in April
2005 for type 1 HRS, and orphan drug designation in October 2004. Read
more...
October
30,
2006
Late-Breaking
Presentation at Liver Meeting Details Results of Phase 3 Study
of terlipressin for Type 1 Hepatorenal Syndrome
At
a late-breaking oral presentation today at the 57th Annual Meeting of the American
Association for the Study of Liver Diseases, topline results of a Phase 3 clinical
trial for terlipressin indicated positive trends in treatment for type 1 Hepatorenal
Syndrome (HRS). The study, conducted by Orphan Therapeutics, was the first randomized,
double-blind, placebo-controlled clinical trial of terlipressin in type 1 HRS
in the United States. HRS is a life-threatening condition characterized by rapid
kidney failure in patients with end-stage liver cirrhosis. Continue
reading this press release, including the abstract article from AASLD, by clicking
here.
August
3, 2006
PDL
BioPharma Reports Results From Phase 3 Trial of Terlipressin
In Type 1 Hepatorenal Syndrome
PDL
BioPharma, Inc. (PDL) (Nasdaq: PDLI) today announced that a double-blind, placebo-controlled,
Phase 3 clinical study of terlipressin, a vasoactive peptide,
did not meet its primary endpoint in the treatment of type 1 hepatorenal syndrome
(HRS), a life-threatening complication of advanced liver disease characterized
by rapidly progressive kidney failure. Read
more...
March
23, 2006
PDL
BioPharma Reports Patient Enrollment Completed for Terlipressin Phase 3 Clinical
Study
Protein
Design Labs, Inc. (PDL) today announced that its partner, Orphan
Therapeutics LLC, has completed enrollment in the pivotal Phase 3 clinical research
study of terlipressin for the treatment of type 1 hepatorenal syndrome (HRS),
a life-threatening complication of liver cirrhosis characterized by rapidly progressive
kidney failure. Read
more...
April
25, 2005
Wall
Street Reporter Interview with Peter Teuber, Ph.D., President of Orphan Therapeutics
The Wall Street Reporter interviewed Peter Teuber, Ph.D.,
President
of Orphan Therapeutics on April 25, 2005. Read about this interview by
clicking
here.
April
20, 2005
PDL
and Orphan Therapeutics Report Fast Track Designation for Terlipressin in Type
1 Hepatorenal Syndrome
Protein Design Labs, Inc. (PDL) (Nasdaq: PDLI) and privately held Orphan Therapeutics,
LLC today reported that the U.S. Food and Drug Administration (FDA) has granted
Fast Track status to the development of terlipressin for the treatment of patients
with type 1 hepatorenal syndrome (HRS). Read
more...
March
14,
2005
Protein
Design Labs, Inc. Acquires
ESP
Pharma Products and Pipeline
On January 25, 2005, PDL and ESP Pharma, a privately
held, sales and marketing-focused pharmaceutical company, announced
a definitive agreement under which PDL would acquire ESP Pharma and its pipeline
of
marketed products and clinical candidates for $300 million in cash
and approximately $175 million in PDL common stock... Read
more...
November
10, 2004
ESP Pharma Announces FDA Grants Orphan Drug Status to
I.V. Terlipressin, a Phase III Development Drug for the Treatment of
Life-Threatening Type 1 Hepato-Renal Syndrome
ESP Pharma, Inc. today announced that the Food and Drug Administration (FDA)
has granted Orphan Drug Designation to I.V. Terlipressin for the treatment of
Type 1 hepato-renal syndrome (HRS), providing seven years marketing exclusivity
upon the completion of clinical studies and FDA approval of the drug for this
indication. Read
more...
June
8, 2004
ESP
Pharma and Orphan Therapeutics in Agreement to Develop and Commercialize
I.V. Terlipressin for Treating Life-Threatening Type 1 Hepato-Renal Syndrome
ESP Pharma, Inc., a niche pharmaceutical company focused on the
acquisition, marketing,
and late-stage development of life-saving acute-care therapeutics,
today announced it entered
into an agreement to acquire from Orphan Therapeutics, LLC (Lebanon,
NJ) rights to intravenous
terlipressin, a novel therapeutic in Phase III clinical trials for
treating Type 1 hepato-renal
syndrome (HRS). Read
more...
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