Business Strategy

The primary goal of Veloxis is to build a clinical and market-stage pharmaceutical business around the key Veloxis late-stage transplant immunosuppression product candidate LCP-Tacro™ and its other pipeline product candidates, as well as continuing to look for and evaluate opportunities to apply the Veloxis proprietary MeltDose® technology in other therapeutic areas with established commercial potential. The key elements of the Veloxis business strategy are as follows:

Advance LCP-Tacro™ through clinical studies within the organ transplantation area. LCP-Tacro™ (once-daily dosage) has received positive phase 2 and 3 clinical data in kidney transplant patients, demonstrating a potential best-in-class profile when compared head-to-head with Prograf® (twice-daily dosage), the only tacrolimus product currently available in the US market. In addition, Veloxis has received positive phase 2 data for LCP-Tacro™ in liver transplant patients. Veloxis has elected to focus its development efforts on pursuing LCP-Tacro™ for the treatment of kidney transplant patients because of the larger potential patient population and demand.

Maximize the full value of the LCP-Tacro™ program by funding in-house through the completion of phase 3 testing and NDA/MAA submission. Veloxis initiated phase 3 clinical studies for LCP-Tacro™ in the second half of 2008 in stable kidney transplant patients and in de novo kidney transplant patients in the fourth quarter of 2010. The de novo transplant study protocol received a Special Protocol Assessment (SPA) from the FDA, which defined the parameters of this phase 3 clinical study protocol. The positive results from the maintenance "switch" phase 3 study were released in June 2011.

Commercialize LCP-Tacro™ in the US and Partner it outside US. Veloxis will build its own dedicated specialty marketing, sales and medical infrastructure to commercialize LCP-Tacro™ in the US. Veloxis will seek to work with a partner/s to commercialize LCP-Tacro™ outside the US, with the aim of maximizing value for Veloxis.

Continue to leverage the Veloxis proprietary MeltDose® technology in additional therapeutic areas with established commercial potential. Veloxis believes that its proprietary MeltDose® technology has broad applicability across multiple existing drugs and disease areas. Veloxis intends to further maximize the commercial value of the MeltDose® technology by applying it to products across a broad range of therapeutic indications where Veloxis believes it can retain significant commercial rights to its products and maximize their commercial potential.

Partner strategically to enhance the commercial potential of the Veloxis product candidates. Veloxis seeks to partner strategically to support development and commercialization of suitable target candidates.