Lucideon Signs Exclusive Agreement with Skyepharma to Develop Abuse-Deterrent Opioid
Lucideon is pleased to announce that it has signed an exclusive feasibility, development and licence agreement with a subsidiary of Skyepharma PLC, the expert oral and inhalation drug development company.
The agreement will provide Skyepharma’s oral business with access to Lucideon’s proprietary iCRT-deter abuse deterrent controlled release technology.
iCRT-deter is a drug delivery technology, from Lucideon’s stable of inorganic controlled release platforms, that has been designed to make drugs difficult to tamper with by methods such as chewing, crushing and heating, whilst retaining the necessary controlled release properties.
Lucideon will work with Skyepharma’s oral business to assess the feasibility of using the technology to develop an abuse deterrent formulation of a major opioid for the U.S. market. If the feasibility stage is successful, Skyepharma will develop the product as a generic for the U.S. market, an investment that Skyepharma predicts will be ca. £4 million over four years.
With a long history in developing inorganic technologies for many different industries and applications, iCRT-deter was developed in response to the growing prescription drug abuse problem in many areas of the world. The U.S. in particular recognizes this as an epidemic, with the U.S. Food and Drug Administration (FDA) proposing an action plan that includes the development of abuse-deterrent formulations of opioid products.
The agreement between Lucideon and Skyepharma will see milestone payments paid to Lucideon as development progresses, together with a single digit share of royalty revenues from Skyepharma’s in-market sales of the product.
Tony Kinsella, Chief Executive of Lucideon, said:
“We are delighted to be working with Skyepharma’s oral business to develop an abuse-deterrent product for the U.S. market. Our iCRT technology platforms have been used successfully in other industries and we are confident that the technology can be translated to develop successful products for the pharmaceutical industry. The agreement cements our reputation as a leading provider of innovative and relevant technology platforms to healthcare, and other industries.”
Gemma Budd, Healthcare Business Manager at Lucideon, said:
“We are excited to be working with Skyepharma’s oral business on this important project. With features such as an extremely high melting point, and a highly porous particulate structure that maintains the controlled release and abuse deterrent features even when crushed, we believe that iCRT-deter will play a pivotal role in deterring abuse of multiple prescription drugs in the future; a technological advancement that benefits not only patients and providers, but society as a whole. The iCRT technology platform has other pharmaceutical applications outside of abuse-deterrence, but this project is an excellent example of how we work with industry to maximize the properties of materials to meet their technical and commercial needs.”
Peter Grant, Chief Executive Officer of Skyepharma, said:
"The agreement with Lucideon is an exciting development for Skyepharma’s oral business. It combines leading and innovative technology from Lucideon with Skyepharma’s proven oral pharmaceutical development capabilities to address a major need in a very large and growing market. The route to market is also highly innovative – the generic (ANDA) route to filing provides a relatively rapid potential for approval, whilst opening up further opportunities should regulators seek to require greater abuse deterrence in marketed opioids.”
07 June, 2016