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GlaxoSmithKline and Amira Pharmaceuticals have entered into a worldwideexclusive agreement to develop, manufacture and commercialise FLAP(5-Lipoxygenase Activating Protein) inhibitors for the treatment ofrespiratory and cardiovascular disease.
Underthe terms of the agreement GSK will be granted an exclusive, worldwidelicense to develop, manufacture and commercialise Amira’s FLAPinhibitors, including AM103 and other compounds within the currentdevelopment programme.
In the event that all potentialdevelopment and regulatory milestones are successfully achieved, Amiracould receive up to US$425 million in upfront and milestone payments.
Inaddition, Amira will be entitled to receive tiered royalty paymentsbased on worldwide net sales and commercial sales milestones.
Initialdevelopment activities will focus on candidate compound AM103, for thetreatment of asthma. Positive data, from a phase I study completed inNovember 2007, show AM103 has the potential as a once-daily, oral,non-steroidal asthma treatment. In this study the compound was alsowell-tolerated.
The prevalence of asthma is increasing globallyand despite the success of inhaled beta-agonist and corticosteroidtherapy there is still a significant need for alternative therapies.
Althoughother therapies are available that target the leukotriene pathway, aFLAP inhibitor has the potential to inhibit a broad spectrum ofleukotrienes.
FLAP inhibitors are also being investigated foruse in other respiratory indications, including rhinitis, as well ashaving potential for the treatment of other inflammatory andcardiovascular diseases.
The global non-steroidal market for thetreatment of asthma and rhinitis is currently worth in excess of US$ 4billion; prescriptions for the treatment of rhinitis contribute 15% tototal worldwide sales of non-steroidals. A FLAP inhibitor with improvedefficacy and equal or improved safety and tolerability to existingleukotriene receptor antagonists, in both asthma and rhinitis, wouldlikely capture a significant portion of this market.
Commentingon the agreement, Dave Allen, SVP Respiratory Centre of Excellence inDrug Discovery, GlaxoSmithKline said: “The role of anti-leukotrieneagents has been well validated in the treatment of respiratorydiseases. We are very excited at entering into this global agreementwith Amira to deliver novel therapies to patients based on thismechanism”.