The primary goal of Veloxis is to obtain regulatory approval in the US and the EU for its late stage development candidate Envarsus® (formerly LCP- Tacro™), and then commercialize the product. The key elements of Veloxis’ business strategy are as follows:
Obtain regulatory approval for Envarsus® within the organ transplantation area.
Envarsus® (once-daily dosage) has received positive Phase II and Phase III clinical data in kidney transplant patients when compared head-to-head with Prograf® (twice-daily dosage). In addition, the Company has received positive Phase II data for Envarsus® in liver transplant patients when compared head-to-head with Prograf®. The Company has elected to focus its development efforts on pursuing Envarsus® for treatment of kidney transplant patients, given the larger potential patient population and demand and has filed regulatory submissions with health authorities in the US and EU for approval of Envarsus® for use as a prophylaxis in prevention of rejection for kidney allograft transplants.
Maximise the full value of the Envarsus® programme by funding in-house through the completion of NDA/MAA submission and commercial launch.
The Company initiated Phase III clinical studies for Envarsus® in stable kidney transplant patients in the second half of 2008 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, and completed enrolment of 543 patients in March 2012 and results of this study were announced in June 2013.
The Company submitted an MAA to the EMA in April 2013 and an NDA to the FDA in December 2013. Regulatory actions on these applications are anticipated to take place in or around the second half of 2014.
Commercialize Envarsus® in the US and partner outside of the US.
The Company plans to commercialize Envarsus® in the US itself and through partnering arrangements in the rest of the world. The Company has concluded a partnership agreement with Chiesi in respect of the commercialization of Envarsus® in certain countries, including Europe, Turkey and CIS Countries.