Amira Pharmaceuticals and GlaxoSmithKline (GSK) will jointly develop, manufacture, and commercialize 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 all Amira's FLAP inhibitors. In the event that all potential development and regulatory milestones are successfully achieved, Amira could receive up to $425 million in upfront and milestone payments. In addition, Amira will be entitled to tiered royalty payments based on worldwide net sales and commercial sales milestones.
Initial development activities will focus on AM103 for the treatment of asthma. Positive data from a Phase I study completed in November, showed AM103 has the potential as a once-daily, oral, nonsteroidal asthma treatment, according to the companies.
“To have identified such a positive drug candidate and progressed to the completion of Phase I trials just two years after the company was founded is a tremendous achievement for the team at Amira,” says Peppi Prasit, CSO and cofounder of 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.”