This partnership will look to launch Aprecia’s proprietary ZipDose product platform, which uses three-dimensional printing technology to create fast-melt products. Aprecia claims the platform allows the production of sponge-like wafer forms of existing medicines.
Under the terms of the agreement, inVentiv will partner with Aprecia as its exclusive provider of commercialization services in exchange for a negotiated royalty from future sales.
Michael Griffith, EVP of inVentiv, told us Aprecia has the rights to market four reformulated therapies, which both companies expect to be approved.
“We think approval is highly likely…as the drugs themselves are already approved – question is the dosage form and does it deliver with its bioavailability,” he said.
Griffith also explained how the commercialization will work from start to finish. “At the beginning it’s the strategy around medical communications to set pricing, to condition clinicians – ads and PR – forming a sales force, develop all of the collateral around that force, and then to work with pharmacies to increase compliance,” Griffith said.
He added that inVentiv is looking “to a do a lot of these types of deals for the commercialization of drugs and devices. This is one example of co-development” where the companies will share risk and reward, he said.
Manufacturing platform
The manufacturing platform from Aprecia does not rely on compression or other processes so the ZipDose formulations can achieve high doses (50 – 1,000mg) without slowing down the speed at which this new form dissolves in the mouth. In addition, the new platform allows for a wider range of taste-masking and time-release technologies than were previously possible, according to Aprecia. The company has filed patent applications to protect its proprietary manufacturing system through 2033.
Aprecia expects to file its first New Drug Application with the US FDA in the second half of 2014, and expects approval of the product in the second half of 2015, though the company has yet to reveal what the product is.