Bentley Pharmaceuticals has announced it will use the North Carolina facilities of US-based services provider Cardinal Health for the scale-up and manufacture of the clinical supplies of its new intranasal insulin product.
The US firm plans to use Cardinal's facility to help it have enough of the trial drug ready in order to expand its global Phase II clinical trials program by the end of the year, but stressed that it is still "in charge of the manufacturing process".
The two companies are already in partnership for the development of the drug with Bentley using Cardinal's other analytical services facility, also based in North Carolina.
"By using Cardinal's full range of solutions, from development to manufacturing and distribution, Bentley maximizes its efficiency and relies on the same high-quality services through the entire drug development and commercialisation cycle," said Cardinal's vice president Shawn Gallagher.
The product candidate uses Bentley's proprietary drug delivery technology, called CPE-215, to deliver insulin directly through diabetic patients' nasal mucosa using a nasal spray.
Currently used treatments require intramuscular injections several times a day.
"There is growing interest in alternative insulin delivery methods that are less intrusive than injection," said John Sedor, Bentley's president.
Bentley recently signed a license agreement with Korea's Dong Sung and India's Biocon to develop and market the product in 85 countries throughout Asia, Africa, and the Middle East upon approval.