Exeter, NH (Sept. 19)—Specialty pharmaceutical company Bentley Pharmaceuticals (www.bentleypharm.com) has entered into an agreement with Cardinal Health (Dublin, OH, www.cardinal.com) for the scale-up of clinical supplies for Bentley’s intranasal insulin product candidate. Under current good manufacturing practices, Cardinal’s North Raleigh (NC) facility will manufacture clinical supplies for Bentley’s “CPE-125” drug delivery technology. The companies previously collaborated at Cardinal’s Research Triangle Park (NC) facility, where the product was characterized.
The platform is designed to deliver insulin through a patient’s nasal mucosa via a small nasal spray. Bentley expects to continue its intranasal insulin program through global Phase II trials this year, according to a statement by company president John A. Sedor.
On Sept. 6, 2006, Cardinal announced it had won approval from the US Food and Drug Administration to begin production at its sterile facility in North Raleigh. Ovation Pharmaceutical’s (www.ovationpharmaceuticals.com) “Panhematin” (hemin for injection) was the first commercial drug to be manufactured at the new facility, which was built in 1997 and acquired when Cardinal bought Magellan Labs in 2001.