Procter & Gamble Pharmaceuticals and ARYx Therapeutics have formed a partnership, which aims to take drug treatments for gastrointestinal disorders to the next level with their novel drug candidate
The two companies are hoping ARYx's novel drug, ATI-7505 will provide a solution to gastrointestinal disorders such as gastroesophageal reflux disease (GERD) and gastroparesis (delayed emptying of the stomach) which affects four to seven per cent of the global population
ATI-7505 is an oral, serotonin type 4 (5HT4) agonist that is currently in Phase 2 development. ATI-7505 has been shown to have prokinetic properties (increases upper GI motility.
Based on its mechanism of action, initial studies has shown show that ATI-7505 prevents the regurgitation of stomach contents into the oesophagus and accelerates the emptying of the stomach.
Under terms of the agreement, ARYx will grant P&G rights to the worldwide development and commercialisation of ATI-7505 in exchange for a $25m (€19.8m) upfront fee, milestone payments, and royalties on product sales.
In addition, ARYx has an option to co-develop and co-promote ATI-7505. In total, payments could reach $435m over the life of the project, including $250m that could be earned prior to commercialisation.
Additional terms also state that ARYx will receive royalties, with the rate escalating upon the achievement of varying sales targets. No further terms of the agreement were disclosed.
"P&G's sales force, and close relationships with gastroenterologists and general practitioners, also makes this collaboration an excellent strategic fit for ARYx," said Paul Goddard, chairman and chief executive officer of ARYx Therapeutics
"We are gratified that P&G shares our passion for improving the safety of drug therapy which has been the major focus of ARYx since it was founded."
Four to seven per cent of the global population represents approximately 250 to 450m people. GERD sufferers can manifest itself as symptoms such as heartburn and regurgitation.
More than 50 per cent of all diabetics suffer from gastroparesis, or more than 85 million people worldwide.
Gastroparesis can lead to severe symptoms such as pain, nausea and vomiting, and even malnutrition.
ATI-7505 is not the first serotonin type 4 (5HT4) agonist to hit the market for gastrointestinal disorders. Propulsid (cisapride), achieved nearly $1bn in global sales, but was withdrawn from the market in 2000 due to side effects.
ATI-7505 was designed using ARYx technology to retain the identical mechanism of action, while eliminating the safety issues.
Clinical trial results to date support this target product profile, but larger studies are required to confirm the drug's efficacy and safety.