Navigation Links
Amira Pharmaceuticals Receives Orphan Drug Status for a Novel LPA1 Antagonist, AM152, for the Treatment of Idiopathic Pulmonary Fibrosis

SAN DIEGO, April 19, 2011 /PRNewswire/ -- Amira Pharmaceuticals, Inc. announced today that AM152, the company's lead LPA1 antagonist, has been granted an orphan drug designation by the U.S. Food and Drug Administration for the treatment of idiopathic pulmonary fibrosis. Commonly referred to as IPF, this fibrotic disease affects the lungs of patients and their ability to breathe.

"This is an important development for Amira, and potentially patients suffering from IPF, as we continue to move this promising therapeutic candidate forward in development," said Bob Baltera, Chief Executive Officer.  "We are currently completing our Phase 1 studies with AM152 and expect to begin a Phase 2 study by the end of 2011 or in early 2012.  Currently there are no FDA-approved therapies for IPF, and we look forward to better understanding the potential therapeutic benefit of an LPA1 antagonist in this disease area."

AM152 is a lysophosphatidic acid (LPA) receptor 1 antagonist.  Activation of the LPA1 receptor by LPA has been implicated in a number of disease processes, including tissue fibrosis.  LPA1 receptor antagonists have displayed efficacy in a wide range of preclinical fibrosis models, including lung, skin, eye, liver and kidney.

About Orphan Drug Designation

The United States Orphan Drug Act of 1983 was created to promote and support the development of new drug therapies for diseases that affect fewer than 200,000 people in the United States.  Orphan Drug Designation provides a sponsor seven years of market exclusivity for the designated therapeutic indication in the United States, from the point at which the therapy is granted marketing approval.  Orphan Drug Designation also provides access to regulatory support from the FDA, potential FDA fee reductions and tax credits related to development expenses.

About Amira

Founded in 2005 and headquartered in San Diego, Amira Pharmaceuticals is a small molecule pharmaceutical company focused on the discovery and early development of new drugs to treat inflammatory and fibrotic diseases.  Amira combines the rigor of a big pharmaceutical company with the ingenuity and energy of a small company, creating an environment for efficient development of novel compounds and effective pre-clinical and clinical program decisions.  Our team is building on unparalleled insights into bioactive lipid pathways and complex signaling processes controlling many conditions including asthma, chronic obstructive pulmonary disease, cardiovascular and various fibrotic diseases.  Amira has a partnership with GlaxoSmithKline for the development of FLAP (5-lipoxygenase activating protein) inhibitors in respiratory and cardiovascular disease.  For more information, visit

SOURCE Amira Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Amira Pharmaceuticals Announces the Nomination of an Orally Available Pre-Clinical Candidate in a New LPA-Related Program, an Autotaxin Inhibitor
2. Amira Pharmaceuticals Announces Initiation of Phase I Clinical Trial for AM152, A Novel LPA1 Antagonist
3. Amira Pharmaceuticals Announces IND Submission for Novel LPA1 Antagonist, AM152, for Potential Use in Fibrotic Diseases
4. Amira Pharmaceuticals Named One of Most Promising Biotech Companies by FierceBiotechs Annual Fierce 15
5. Visage Imaging Releases Amira 5.3
6. Amira Announces AM103 and AM803 Patent Grant in the United Kingdom
7. Amira Announces Second DP2 Antagonist Patent Grant in the United Kingdom
8. Anti-Fibrotic Data from Amira Pharmaceuticals LPA1 Receptor Antagonist Program Published in the British Journal of Pharmacology
9. Amira Pharmaceuticals Announces Efficacy of LPA1 Antagonist in a Preclinical Model of Scleroderma
10. Amira Pharmaceuticals Announces Initial Positive Phase 1 Clinical Data for AM461, A Back-Up to Amiras Lead DP2 Antagonist, AM211
11. Amira Pharmaceuticals Submits IND for Second DP2 Antagonist, AM461
Post Your Comments:
(Date:6/24/2016)... Tenn. , June 24, 2016  Arkis ... providing less invasive and more durable cerebrospinal fluid ... in funding.  The Series-A funding is led by ... Lighthouse Fund, and other private investors.  Arkis, new ... neurosurgical instrumentation and the market release of its ...
(Date:6/23/2016)... Research and Markets has announced the addition of ... report to their offering. ... kidney failure, it replaces the function of kidneys by removing ... thus the treatment helps to keep the patient body,s electrolytes ... Increasing number of ESRD patients & substantial healthcare expenditure ...
(Date:6/23/2016)... -- Research and Markets has announced the ... (Organic Chemical (Sugar, Petrochemical, Glycerin), Inorganic Chemical), Functionality (Filler, ... Global Forecast to 2021" report to their offering. ... pharmaceutical excipients market is projected to reach USD 8.1 ... the forecast period 2016 to 2021. ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... ... a legally blind and certified personal trainer is helping to develop a weight loss fitness ... to fix the two major problems leading the fitness industry today:, , ... They don’t eliminate all the reasons people quit their exercise program ...
(Date:6/25/2016)... Miami, FL (PRWEB) , ... June 25, 2016 , ... The temporary closing of Bruton ... Plant City Observer , brings up a new, often overlooked aspect of head lice: ... The closing for fumigation is not a common occurrence, but a necessary one in the ...
(Date:6/25/2016)... ... June 25, 2016 , ... ... recover from injury. Recently, he has implemented orthobiologic procedures as a method for ... is one of the first doctors to perform the treatment. Orthobiologics are substances ...
(Date:6/24/2016)... ... , ... Those who have experienced traumatic events may suffer from a complex ... as drug or alcohol abuse, as a coping mechanism. To avoid this pain and ... a traumatic event. , Trauma sufferers tend to feel a range of emotions, from ...
(Date:6/24/2016)... ... 2016 , ... Global law firm Greenberg Traurig, P.A. announced that 20 Florida ... their peers for this recognition are considered among the top 2 percent of lawyers ... as members of this year’s Legal Elite Hall of Fame: Miami Shareholders Mark ...
Breaking Medicine News(10 mins):