GSK licenses Amira FLAP blockers in $425M deal

UK drug major GlaxoSmithKline has bought exclusive rights to several early-stage drug candidates from Amira Pharmaceuticals in a deal that could be worth up to $425.0 million to the San Diego, USA-based firm.

Under the terms of the deal, GSK will be granted an exclusive, worldwide license to develop, manufacture and commercialize Amira's 5-Lipoxygenase Activating Protein (FLAP) inhibitors, including the lead candidate AM103. In the event that all potential development and regulatory milestones are achieved, Amira could receive up to $425.0 million in upfront payments and milestones, as well as tiered royalties on net sales and commercial 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, Amira noted, adding that the global non-steroidal market for asthma and rhinitis is currently worth over $4.0 billion, with prescriptions for the treatment of rhinitis contributing 15% to total world sales of non-steroidals. A FLAP inhibitor with improved efficacy and equal or better safety and tolerability to existing leukotriene receptor antagonists could capture a significant portion of this market.