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Amira Pharmaceuticals Announces Positive Initial Data From a Phase 1 Study of AM103, A Novel Product Candidate for the Treatment of Respiratory and Cardiovascular Disease

SAN DIEGO, California, July 16, 2007 /PRNewswire/ -- Amira Pharmaceuticals, a small molecule pharmaceutical company focused on the discovery and development of compounds to treat inflammatory diseases linked to the eicosanoid pathway, today announced initial, positive data from a Phase 1 clinical trial of AM103, the company's lead compound. The early, interim results demonstrate that a single dose of AM103 achieves highly significant inhibition of leukotriene synthesis.

AM103 is an oral, next generation inhibitor of 5-lipoxygenase-activating protein (FLAP) that has demonstrated potential to treat asthma and cardiovascular disease (CVD) by preventing the synthesis of leukotrienes, biological compounds which lead to inflammation. The current placebo- controlled, double-blind Phase 1 study is designed to determine the safety and tolerability of an escalating single dose and escalating multiple doses of AM103 in healthy volunteers. The trial is also assessing the pharmacokinetic and pharmacodynamic properties of the compound, specifically its ability to inhibit leukotriene production.

"With our preclinical models of pharmacokinetics and pharmacodyamics, we very accurately predicted the results demonstrated to date in this Phase 1 study of AM103," said Jilly Evans, PhD, vice-president biology and co- founder, Amira Pharmaceuticals. "This capability is a real source of competitive advantage for Amira as we design new kinds of leukotriene inhibitors."

The approval of the company's Clinical Trial Application (CTA), submitted in Europe earlier this year, allowed Amira to start the AM103 Phase 1 clinical trial. The company expects to have final data from the study during Q4 2007. Based on these and earlier data, Amira plans to file an application for an Investigational New Drug (IND) in the United States during 2008. Results from the trial will also enable the company to identify the optimal dose of AM103 for Phase 2 studies.

"Our pre-clinical studies of AM103 demonstrated that a low dose is effective in several inflammatory models," said Peppi Prasit, PhD, chief scientific officer, Amira Pharmaceuticals. "Recent studies have shown that leukotrienes are implicated in atherosclerosis, suggesting that AM103 may have tremendous potential in cardiovascular indications in addition to the recognized respiratory indications."

The respiratory market for this compound is estimated to be worth between US$2-3 billion, and the cardiovascular market may be even greater. Discussions are currently underway with several potential pharmaceutical partners.

"The start of this trial just two years after Amira's founding was a testament to the company's scientific rigor and focus, as well as the experience of the scientific and management team," said Brad Bolzon, managing director of Versant Ventures, a founding investor in Amira. "Based on the initial Phase 1 study data, it's clear that the approach the team brought into this company is already delivering value."

About FLAP Inhibitors

FLAP is a key component early in the leukotriene pathway, a complex signaling process that exerts control over biological processes, such as inflammation and immunity. Excessive activity of FLAP exacerbates inflammatory diseases, such as asthma; the FLAP gene has also been linked to a significant increase in the risk of myocardial infarction and stroke. AM103 binds to FLAP, inhibiting the synthesis of leukotrienes that cause inflammation.

A FLAP inhibitor is active at a point higher in the leukotriene pathway than a CysLT1 receptor antagonist, enabling it potentially to inhibit all leukotrienes and their receptors. Leukotrienes, prostaglandins and other arachidonic acid-derived lipids make up the eicosanoid family of inflammatory mediators.

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 eicosanoid pathway.

The company 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.

In January 2006, Amira signed a collaboration with Roche to establish a research alliance and an option for Amira to license two clinical-stage compounds from Roche. Amira has yet to exercise its option.

Amira has raised US$40 million to date from investors including Novo A/S (Copenhagen, Denmark), Avalon Ventures (San Diego, CA), Prospect Ventures (Palo Alto, CA) and Versant Ventures (Menlo Park, CA). For more information, visit

    Contact Amira Pharmaceuticals:

    In Europe:

    Julie Walters at Media Speak

    Tel: +44-(0)1494-753-990

    Mobile: +44-(0)775-362-6967


    In US:

    Michele Parisi at Media Speak

    Tel: +1-925-429-1850

    Mobile: +1-925-864-5028

CONTACT: Contact Amira Pharmaceuticals: In Europe: Julie Walters at MediaSpeak, Tel: +44-(0)1494-753-990, Mobile: +44-(0)775-362-6967,; In US: Michele Parisi at Media Speak, Tel:+1-925-429-1850, Mobile: +1-925-864-5028,

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Posted: July 2007