DURECT has signed a development and license agreement with Orient Pharma. Under the terms of the agreement, DURECT has granted development and commercialization rights to Orient Pharma, in selected Asian and South Pacific countries, for Oradur-ADHD.
The drug candidate, based on DURECT’s Oradur Technology, is a specified active pharmaceutical ingredient for the treatment of attention deficit hyperactivity disorder (ADHD).
The drug candidate (Oradur-ADHD) is intended to provide once-a-day dosing with added tamper-resistant characteristics to address common methods of abuse and misuse of these types of drugs.
Under the agreement, the parties will collaborate to perform a clinical development program through a phase II study intended to produce a data package. It will support later stage development of the drug candidate by DURECT as well as Orient Pharma in their respective territories.
In addition, DURECT will be responsible for formulation and study design of the pre-defined clinical program which Orient Pharma will fund and execute.
Moreover, Orient Pharma will be responsible for all remaining development and commercialization activities for this Oradur-ADHD product in the licensed territory.
Reportedly, if commercialized, DURECT will receive a royalty on sales of Oradur-ADHD by Orient Pharma. Orient Pharma will supply a portion of DURECT’s commercial requirements for Oradur-ADHD in all territories other than the US.
James Brown, president and CEO of DURECT, said: We’re pleased to announce this collaboration with Orient Pharma which will put us in a position to generate phase II data for our Oradur-ADHD program, provide us with a commercial supply source as well commercially exploit this product opportunity in this region with an established company. Abuse of stimulants remains a major healthcare problem and we look forward to working with Orient Pharma to applying our Oradur technology to this product category.