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Amira Announces the Successful Completion of GLP Toxicity Studies for a Novel DP2 Antagonist.
Date:1/6/2009

Lead candidate on track for IND submission first half of 2009.

SAN DIEGO, Jan. 6 /PRNewswire/ -- Amira Pharmaceuticals, Inc. announced AM211, Amira's internally discovered oral drug candidate for the treatment and control of inflammatory and allergic diseases linked to the arachidonic acid pathway, is on target for submission of an IND to the U.S. Food and Drug Administration (FDA) by mid-2009 following the successful completion of Good Laboratory Practices (GLP) toxicity studies.

AM211 is an oral, selective antagonist of the receptor DP2 (also known as CRTH2 or chemoattractant receptor-homologous molecule expressed on Th2 lymphocytes). DP2 is a high affinity receptor for prostaglandin (PG) D2 and, in humans, is implicated in Th2-dependent allergic inflammation. Recent studies have shown that a DP2 antagonist has the potential to be an oral treatment for asthma, Chronic Obstructive Pulmonary Disease (COPD) and allergic rhinitis.

"Our pre-clinical studies demonstrate that a low dose of AM211 is effective in several inflammatory/allergic models," said Peppi Prasit, PhD, Chief Scientific Officer, Amira. "Based on the pharmacokinetics and pharmacodynamics in preclinical models and its safety profile, we believe that AM211 has the potential to be an exciting next generation, once a day oral medication for respiratory diseases including COPD. In addition, we have a structurally distinct backup compound, AM461, about to enter GLP toxicity studies."

"Amira is establishing a track record of rapid and efficient discovery and early drug development. For the second time in as many programs, Amira is on track to enter human studies within two years from program start," said Bob Baltera, Amira's Chief Executive Officer. "These are exciting times at Amira as our team continues to demonstrate world-class capabilities in drug discovery and development."

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 compounds to treat inflammatory disease linked to the phospholipid pathways. Amira has a strategic partnership with GlaxoSmithKline for the development of FLAP (5-lipoxygenase activating protein) inhibitors in respiratory and cardiovascular disease.

Amira combines the rigor of a big pharmaceutical company with the ingenuity and energy of a small company, creating an environment for efficient and effective pre-clinical and clinical program decisions. Its scientific founders have successfully worked together for more than a decade and were pivotal in the discovery of a number of inflammatory drugs, including Singulair(R). The drug hunters at Amira are now actively leveraging their history of success to create high-value compounds for the future. For more information, visit www.amirapharm.com.


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SOURCE Amira Pharmaceuticals, Inc.
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