Albany Molecular Research (AMRI) has announced a multi-year drug substance manufacturing agreement with New River Pharmaceuticals, as its attention deficit hyperactivity disorder (ADHD) medicine looks set to hit the market.
Under the agreement, AMRI will manufacture the active pharmaceutical ingredient (API) in New River's compound, NRP104, that is currently under review with the US Food and Drug Administration (FDA).
With an estimated 2.5m US children using ADHD drugs, New River is confident AMRI will be able to successfully scale up production ahead of an anticipated launch in 2007.
"We are well positioned to manufacture this compound based on our long history of manufacturing, as well as our strength in chemical development," AMRI CEO Thomas D'Ambra said.
"AMRI is delighted to continue its relationship with New River Pharmaceuticals."
AMRI has already collaborated with New River in the development of the chemical process to manufacture NRP104.
NRP104, is New River's most advanced compound, designed along with Shire for oral delivery and made as an pharmacologically inactive prodrug using New River's Carrierwave technology.
This technology creates a new derivative molecule made of the API of a drug such as an amphetamine or opioid, covalently attached to an adjuvant. The pharmacologically inactive drug is only activated, or "bioreversed", when taken as directed.
In NRP104, d-amphetamine is covalently bonded to l-lysine, a naturally occurring amino acid, and it is not until undergoing hydrolysis that the pharmacologically active d-amphetamine molecule is gradually released, making drug tampering difficult and impractical.
Thus, this method confers overdose protection by restricting the release of the API from the formalation at greater than therapeutically prescribed amounts. The drug is also designed to be less prone to abuse and addiction by limiting the "rush" or "high" available from the API released and limiting the ability of abusers to obtain greater doses of the active ingredient through alternative routes of administration or extraction techniques.
NRP104 was designed with the expectation to have comparable efficacy and tolerability to currently marketed once-daily extended-release stimulants with reduced potential for abuse, diversion and overdose toxicity.