Aricept (donepezil) was developed by Eisais and Pfizer as a drug to improve cognition and behaviour among patients with Alzheimer’s disease, and while there are a number of oral generic versions available, Corium International is looking to bring a version delivered through a transdermal patch to multiple market.
The product – Corplex Donepezil – could be launched in mid-2019 and according to the firm it is actively pursuing commercialisation partners.
“We're in talks with several parties who are interested in rights to specific geographic territories as well as some who desire a more global relationship,” Peter Staple, CEO of the California-headquartered company said in a financial call last week.
“We've met with regulatory authorities in Europe and Asia and we continue to have follow-up interactions to gain additional visibility on the regulatory requirements in these different geographies. This has been important for parties looking to market the product outside of the US.”
Staple added his firm is looking to sign a deal by the end of this calendar year, but admitted “negotiations could continue into 2018 as some parties are perusing multiple regions or global transactions.”
Corplex Donepezil intends to be a once-weekly treatment delivered by a transdermal patch. Corium claims transdermal delivery improves adherence rates, which is particularly important for a disease like Alzheimer’s, while reducing gastrointestinal (GI) side effects seen with oral formulations due to the avoidance of the GI tract.
“The FDA [US Food and Drug Administartion] has dedicated a considerable time to Corplex Donepezil and shows continued interest in transdermal products in general,” Staple told stakeholders. “During the summer at the FDA's request we hosted a group of agency staff for a two-day training session on transdermal technologies and manufacturing at our facility in Grand Rapids, Michigan.”
The site boasts 200,000 square feet of manufacturing space and has capacity to manufacture over 100 million patches annually.
“This FDA continuing education programme is designed to inform and keep the agency up to date with developments in different dosage forms and process technologies. It was an excellent opportunity for us to provide the staff additional insight into and contacts for our work.”