inVentiv Health, a life science knowledge and services company, and Aprecia Pharmaceuticals Company, a specialty pharmaceutical company, have formed a sales and marketing alliance to advance Aprecia’s technology and initial pharmaceutical products using three-dimensional printing (3DP) technology.

Aprecia’s proprietary ZipDose  formulation platform uses 3DP technology to create fast-melt products. The platform produces sponge-like wafer forms by “stitching” together superabsorbent wafers using a proprietary process. Aprecia has completed clinical work and expects to file its first new drug application for pharmaceutical using the technology with FDA in the second half of 2014. The company has an exclusive worldwide license for 3DP technology originally developed at Massachusetts Institute of Technology (MIT) for use in pharmaceutical applications.

Under the terms of the agreement, inVentiv will partner with Aprecia as its exclusive provider of commercialization services and will share in the success of the commercialization efforts.  inVentiv will invest time and materials to launch Aprecia and to commercialize its products in exchange for a negotiated royalty from future sales. inVentiv's services include: sales teams and sales training, strategic and tactical market access services, non-personal promotion, advertising, public relations, adherence services, and full management of the commercialization teams.

Aprecia Pharmaceuticals Company was founded in 2003 with the goal of achieving commercial production rates for pharmaceutical dosage forms made possible by 3DP. Initially positioned as a rapid-prototyping technique, powder-liquid 3DP was first developed at MIT in the late 1980s and was licensed for a diverse range of industrial fields in the early 1990s. From 1993-2003, the original licensee for medical applications, Therics Inc., expanded the research from MIT into areas of tissue engineering and pharmaceutical use, ultimately focusing its business on tissue applications and returning pharmaceutical rights back to MIT. These rights are now licensed exclusively to Aprecia, according to the company. Since 2007, Aprecia has focused on applying 3DP to a fast-melt formulation platform known as ZipDose technology. By 2008, Aprecia reached its initial goal with a new proprietary forming system that uses a novel implementation of the 3DP steps to achieve higher throughput, further refining the design through 2011 to meet pharmaceutical regulatory expectations. In 2011, the company began operations at its registration and launch facility in East Windsor, New Jersey.  After refining and commissioning its first full production line, this site is positioned for registration of its initial ZipDose product set, with the first regulatory filing with FDA targeted in the fourth quarter of 2014.

Source: Aprecia Pharmaceuticals