The Taifun device was a reservoir-type DPI, which meant that fentanyl would always remain inside for dosing reasons. Even if the multi-dose inhaler could be converted to single-dose, as the company contemplated, a certain amount of fentanyl would still be retained after use due to static. Regulators would naturally have concerns about the use and disposal of such a device, Emmelot acknowledges. When a European trial of the product ended in 2008 after dosing of the 13th patient, he says, the project was halted.
Masood Tayebi and Rudy Emmelot
According to Emmelot, Akela investigated the possibility of a second generation device that would take various issues into account, including child safety locks, disposal, and the potential for abuse. Its partners in the Taifun fentanyl project, Takeda and Janssen Pharmaceutica, however, questioned the economic viability of a redesign, especially given problems with other inhaler projects at the time, including the failure of Exubera inhaled insulin.
In 2011, the two companies decided to stop development of the product and return the rights to Akela. Akela hired consultants to help find new partners for the inhaled fentanyl project, Emmelot says, but “no one was interested in picking it up.” With no takers for the IP, most of the patents will eventually lapse.
Now, Emmelot says, B.I.G.’s resources will allow the company “to increase its capabilities, taking our clients further down the development pipeline,” so that “our clients can transfer when they want to transfer and not be limited by our capacity for advancing the manufacturing process.” In addition to the financial resources necessary to stabilize the company, Tayebi also brings extensive experience with life sciences, having founded BioDuro, a drug discovery CRO he later sold to PPD.
According to Tayebi, he plans to turn Formex into a full service CDMO, adding commercial manufacturing to the company’s capabilities. As part of that process, he hopes to double the size of the staff up to about 75-80 employees by the end of 2014, and he says that he plans to maintain Formex’s inhalation capabilities is part of his strategy to differentiate Formex from other CDMOs.
