Navigation Links
Amira Pharmaceuticals Receives Orphan Drug Status for a Novel LPA1 Antagonist, AM152, for the Treatment of Idiopathic Pulmonary Fibrosis
Date:4/19/2011

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 www.amirapharm.com.


'/>"/>
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:
*Name:
*Comment:
*Email:
(Date:5/26/2016)... , May 26, 2016   ... software and analytics, network solutions and technology-enabled ... announced it entered into a strategic channel ... of outpatient software solutions and revenue cycle ... specialty hospitals and rehabilitation clinics to optimize ...
(Date:5/25/2016)... GERMANTOWN, Maryland , May 25, 2016 ... bedient dringenden Bedarf zur ... QIAGEN N.V. (NASDAQ: QGEN ; Frankfurt ... und Entwicklungsvereinbarung mit Therawis Diagnostics GmbH zur Entwicklung ... zu sein. Ein erstes Projekt wird die Entwicklung ...
(Date:5/25/2016)... 2016 According to market research ... and Demand Forecast to 2022 - Industry Insights by ... published by P&S Market Research, the global insulin delivery ... and it is expected to grow at a CAGR ... pump segment is expected to witness the fastest growth ...
Breaking Medicine Technology:
(Date:5/27/2016)... ... 2016 , ... This campaign aims to provide a path to improved education ... control and change. , As nearly 795,000 Americans suffering from a new or recurrent ... Plus, with an estimated 129,000 of these people dying from stroke, it’s become our ...
(Date:5/27/2016)... ... May 27, 2016 , ... Aimed at nurses and employees ... stories, courtesy of leaders in the nursing and health care industry. It also ... advocates and associations—namely Jones & Bartlett Learning. , Jones & Bartlett Learning is ...
(Date:5/26/2016)... ... May 26, 2016 , ... Despite last week’s media reports ... Yellen and company to wait until March 2017 for an interest rate increase, according ... Robinson College of Business. , “The Federal Open Market Committee (FOMC) dot charts are ...
(Date:5/26/2016)... (PRWEB) , ... May 26, 2016 , ... ... and clinical outcomes, hosted members and suppliers for its inaugural Member Conference at ... on their mission of elevating the operational health of America’s healthcare providers. , ...
(Date:5/26/2016)... Florida (PRWEB) , ... May 26, 2016 , ... ... House® Project offering a new model of care for living and healing, celebrated ... core values: Meaningful Life in a Real Home provided by Empowered Staff. , “This ...
Breaking Medicine News(10 mins):