The compound is being developed for the treatment of allergic rhinitis and asthma

Barcelona, Spain, July 20, 2009 - Palau Pharma, S.A. ("Palau"), the biopharmaceutical company focused on the discovery and development of innovative products for the treatment of inflammatory and autoimmune diseases, today announces the initiation of a Phase I clinical trial of its novel oral histamine H₄ receptor (H₄R) antagonist for the treatment of allergic rhinitis and asthma.  This is a first-in-man double blind, placebo controlled, dose escalation, single-center study in healthy volunteers that has been designed to assess the product's safety and tolerability in humans as well as evaluate its pharmacodynamic and pharmacokinetic profiles in preparation for a Phase II proof-of-concept study in patients with allergic rhinitis and asthma.

"We are excited to begin this trial that adds to our portfolio of products under clinical development. This is especially important since the histamine H₄ receptor antagonist program is the first to be entirely discovered in Palau since the inception of our Company a little over two years ago," said Ignacio Faus, Chief Executive of Palau. "This study is due to finalize by the end of 2009, after which a multiple dose proof-of-concept trial will follow."

This potent antagonist has shown a good specificity profile for the H₄R and a pharmacokinetic profile that should support a once-a-day administration approach. The high anti-inflammatory activity, together with the efficacy results seen in non-clinical models and its suitable toxicology profile suggest a promising approach to both manifestations of respiratory inflammation, especially when both allergic rhinitis and asthma coexist. The compound could improve the efficacy ceiling and become more patient-friendly than currently available alternatives.

About H₄R
Almost half of modern medicines are directed against G-protein coupled receptors ^[1]. This family of receptors includes the histamine receptors, of which four different subtypes have been identified (H₁R, H₂R, H₃R and H₄R). The link between the H₁R and H₂R and immunomodulating mechanisms has long been known. However, drugs directed against these targets have been shown to just reduce the symptoms, instead of targeting the underlying mechanism of the diseases. In contrast, H₄R is a newly identified receptor whose function in immunology, specifically in several allergic and immune-inflammatory disorders, has only been established in the last few years. The H₄R antagonist approach aims to target the allergy-mediated inflammation, not only the symptoms, turning it into a promising novel drug target.

The link between allergic rhinitis and asthma
Epidemiological, immunological and clinical data have established a link between allergic rhinitis and asthma^[2], two diseases increasingly present in our society.  While almost half of all allergic rhinitis patients also have asthma, a vast majority of asthmatics experience nasal symptoms. In fact, patients with allergic rhinitis are at three times the risk of developing asthma compared with those without allergic rhinitis, suggesting that upper airway disease is a risk factor for asthma. Furthermore, the European Academy of Allergology and Clinical Immunology (EAACI) recommends that doctors combine the treatment of both conditions wherever possible^[3].

About Palau Pharma
Palau Pharma, S.A. is a product-driven biopharmaceutical company focused on the discovery and development of innovative, improved and safer medicines for the treatment of diseases with identified unmet medical needs in the inflammatory and autoimmune fields. Palau's pipeline consists of 10 projects addressing diseases such as asthma, allergic rhinitis, atopic dermatitis, and ulcerative colitis, six of which are in clinical development. One project, the drug-eluting coronary stents ACTIVE^® and IRIST^®, is already being commercialized by one of our partners. Headquartered in Barcelona, Spain, Palau was founded in November 2006, raising €40 M from institutional investors that include Caja Duero, Andosins Capital, Caixa Catalunya and Najeti Capital.

^[1] Modern Drug Discovery (American Chemical Society) November 2004

^[2] Current Opinion in Allergy and Clinical Immunology 02/26/2004

^[3] "Allergic Rhinitis And Its Impact On Asthma" (ARIA) guidelines