Amira Pharmaceuticals Announces Initial Positive Phase 1 Clinical Data for AM211,...

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Tue Jun 30, 2009 9:01am EDT

Amira Pharmaceuticals Announces Initial Positive Phase 1 Clinical Data for
AM211, a Novel Product Candidate for the Treatment of Respiratory Diseases

Results Demonstrate Positive Proof of Mechanism

SAN DIEGO, June 30 /PRNewswire/ -- Amira Pharmaceuticals, Inc. announced today
initial positive data from a Phase 1 clinical study of AM211, the company's
oral selective antagonist of the DP2 (also known as CRTH2) receptor.

The interim results demonstrate that a sustained pharmacodynamic (PD) effect
can be achieved with a single dose of AM211. The pharmacokinetic profile
indicates safety multiples as compared to exposures observed in safety
species. While there are no DP2 selective antagonists approved for therapeutic
use, there is a strong scientific rationale for this target to be a novel
treatment of asthma, chronic obstructive pulmonary disease (COPD) and allergic
rhinitis.

"The AM211 clinical PD data confirms what we previously observed in
pre-clinical models," said Isabelle DeArmond, M.D., Vice President, Clinical
Development. "While a great deal of clinical work remains on this program, we
are particularly excited since we believe DP2 antagonism would be a novel
therapeutic approach to various respiratory diseases."

Bob Baltera, Chief Executive Officer, added, "Once again the Amira team
demonstrates our ability to quickly, efficiently and accurately translate
scientific efforts into meaningful therapeutic candidates. The fact that we
now have clinical data only 25 months after we initiated scientific efforts on
this target in our laboratories is a source of pride for the entire Amira
team."

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 disease. Our discovery 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 fibrotic diseases.

Amira has a 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 development of novel compounds 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.

    Media Contact
    Ian Stone
    Russo Partners
    Tel: +1 619 528 2220
    ian.stone@russopartnersllc.com



SOURCE  Amira Pharmaceuticals, Inc.

Ian Stone of Russo Partners for Amira Pharmaceuticals, Inc., +1-619-528-2220,
ian.stone@russopartnersllc.com
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