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:6/26/2016)... Ontario , June 27, 2016  VMS Rehab ... Company,s Board will take whatever measures required to build ... Company,s stock which is currently listed on the OTC ... Wexler, Company Chairman and CEO, "We are seeing an ... difficult to understand, not only by the Company, but ...
(Date:6/24/2016)... CHAPEL HILL, N.C. , June 24, 2016 ... in healthcare decisions and regulators/payers have placed more ... this new environment, patient support programs in the ... support for patients, medications. Consequently, pharmaceutical companies are ... to ensure they are providing products and services ...
(Date:6/24/2016)... SAN FRANCISCO, Calif. , June 24, 2016 ... GBT ), a biopharmaceutical company developing novel therapeutics ... significant unmet needs, today announced the closing of ... shares of common stock, at the public offering ... shares in the offering were offered by GBT. ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... 25, 2016 , ... Experts from the American Institutes for ... Meeting June 26-28, 2016, at the Hynes Convention Center in Boston. , AIR ... care planning, healthcare costs and patient and family engagement. , AIR researchers will ...
(Date:6/25/2016)... CA (PRWEB) , ... June 25, 2016 , ... As ... with Magna Cum Laude and his M.D from the David Geffen School of Medicine ... and returned to Los Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive ...
(Date:6/24/2016)... ... ... Those who have experienced traumatic events may suffer from a complex set ... drug or alcohol abuse, as a coping mechanism. To avoid this pain and suffering, ... traumatic event. , Trauma sufferers tend to feel a range of emotions, from depression, ...
(Date:6/24/2016)... ... June 24, 2016 , ... Dr. Amanda Cheng, an ... Cheng has extensive experience with all areas of orthodontics, including robotic Suresmile technology, ... , Micro-osteoperforation is a revolutionary adjunct to orthodontic treatment. It can be ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Haute Beauty Network, affiliated ... Weintraub as a prominent plastic surgeon and the network’s newest partner. , ... most handsome men, look naturally attractive. Plastic surgery should be invisible.” He stands ...
Breaking Medicine News(10 mins):