GlaxoSmithKline and Amira Pharmaceuticals enter global agreement for FLAP inhibitor programme

Deal follows positive phase I data from novel product candidate AM103 for the oral treatment of respiratory disease

GlaxoSmithKline and Amira Pharmaceuticals today announced they have entered into a worldwide exclusive agreement to develop, manufacture and commercialise FLAP (5-Lipoxygenase Activating Protein­) inhibitors for the treatment of respiratory and cardiovascular disease.

Under the terms of the agreement GSK will be granted an exclusive, worldwide license to develop, manufacture and commercialise Amira’s FLAP inhibitors, including AM103 and other compounds within the current development programme. In the event that all potential development and regulatory milestones are successfully achieved, Amira could receive up to US$425 million in upfront and milestone payments. In addition, Amira will be entitled to receive tiered royalty payments based on worldwide net sales and commercial sales milestones.

Initial development activities will focus on candidate compound AM103, for the treatment of asthma. Positive data, from a phase I study completed in November 2007, show AM103 has the potential as a once-daily, oral, non-steroidal asthma treatment. In this study the compound was also well-tolerated.

The prevalence of asthma is increasing globally and despite the success of inhaled beta-agonist and corticosteroid therapy there is still a significant need for alternative therapies. Although other therapies are available that target the leukotriene pathway, a FLAP inhibitor has the potential to inhibit a broad spectrum of leukotrienes. FLAP inhibitors are also being investigated for use in other respiratory indications, including rhinitis, as well as having potential for the treatment of other inflammatory and cardiovascular diseases.

The global non-steroidal market for the treatment of asthma and rhinitis is currently worth in excess of US$ 4 billion; prescriptions for the treatment of rhinitis contribute 15% to total worldwide sales of non-steroidals. A FLAP inhibitor with improved efficacy and equal or improved safety and tolerability to existing leukotriene receptor antagonists, in both asthma and rhinitis, would likely capture a significant portion of this market.

Commenting on the agreement, Dave Allen, SVP Respiratory Centre of Excellence in Drug Discovery, GlaxoSmithKline said: “The role of anti-leukotriene agents has been well validated in the treatment of respiratory diseases. We are very excited at entering into this global agreement with Amira to deliver novel therapies to patients based on this mechanism”.

In addition Moncef Slaoui, Chairman R&D, GSK said: “As leaders in the development, manufacture and marketing of medicines for respiratory diseases GSK is pleased to be introducing this treatment to our product pipeline. We believe AM103, a novel FLAP inhibitor, has the potential to offer patients a convenient and effective alternative treatment for respiratory diseases including asthma and rhinitis.”

Peppi Prasit, Chief Scientific Officer and Co-Founder Amira said: “To have identified such a positive drug candidate and progressed to the completion of phase I clinical trials just two years after the company was founded is a tremendous achievement for the team at Amira. We are delighted that GlaxoSmithKline will be taking this asset into full development. With their experience and expertise in this area we hope that AM103 will become the first FLAP inhibitor available to patients worldwide to treat symptoms of asthma and possibly other inflammatory diseases.”

“This is a momentous day in the young life of Amira” said Bob Baltera, Chief Executive Officer, Amira. “This deal validates the abilities and expertise in Amira to expedite the delivery of novel medicines. We are particularly pleased to have entered this agreement with GSK, one of the leading pharmaceutical companies in the world, and a company that has a strong heritage in the treatment of respiratory diseases.”