After the recent completion of the final Phase III clinical trial of Envarsus® (LCP-Tacro), the main focus of Veloxis is to obtain regulatory approval for Envarsus® in the United States and the European Union, and then commercialize the product. The key elements of Veloxis’ business strategy are as follows::
Obtain regulatory approval within the organ transplantation area
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 was completed with positive results in June 2013. Thus, no further clinical studies are outstanding before NDA/MAA approval can be obtained. The Company has elected to focus its commercialization efforts on pursuing Envarsus® for treatment of kidney transplant patients, given the larger potential patient population and demand.
Maximise the full value of the Envarsus® programme by funding in-house through NDA/MAA submission and commercial launch in the US
The Company aims at NDA submission in the second half of 2013 and commercial launch in the second half of 2014, enabling the Company to execute its strategy of commercializing in the United States itself and through partnering arrangements in the rest of the world. This strategy is intended to maximise the full value of the programme. In April 2013, Veloxis submitted a marketing authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval to market Envarsus® for the prevention of organ rejection in kidney transplant patients in the European Union.
Given the special characteristics of the organ transplant market, the field force required to market successfully in the transplant space is relatively small. Consequently, assuming successful completion of the Phase III programme, the Company currently plans to establish its own sales force in the United States. In relation to other jurisdictions, 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.