Sweden-based Orexo and the Chinese pharmaceutical company NovaMed Pharmaceuticals have signed an exclusive licensing and distribution agreement that grants NovaMed rights to seek approval for the marketing and distributing of Abstral Orexo´s product for treatment of breakthrough cancer pain in mainland China and, if granted, to market and sell the product in that market.
The terms of the agreement includes an upfront payment, regulatory milestones and sales milestones. The total value of the upfront payment and milestones are USD4.75 million. In addition, Orexo will supply NovaMed with Abstral in China and will receive margins on the sales of the product if approved. NovaMed will be responsible for managing the regulatory approval process including clinical studies, which is a standard requirement in China.
Abstral is a fast-dissolving tablet for sub-lingual administration of fentanyl, intended for the management of breakthrough cancer pain in patients who are already receiving opioid analgesics. It is based on Orexo´s patented sublingual tablet technology in which a rapidly dissolving tablet is placed under the tongue and the active substance is absorbed by the mucous membrane. Currently Abstral is sold in Sweden and is being launched in UK and Germany.
NovaMed Pharmaceuticals was founded in August 2005 to provide a one-stop-shop service for global pharmaceutical companies and brand owners looking to leverage cost advantage and achieve optimal market potential in China. It has a directly managed sales organization of 400 people, and a network of research, development, regulatory and distribution partners. NovaMed has built commercialization models for products at different stages of their lifecycle including products already commercially available in China, internationally approved products not yet registered in China, and in-license late stage development compounds.