The primary goal of Veloxis is to complete its ongoing Phase III clinical studies of LCP-Tacro, to obtain regulatory approval in the United States and the European Union, and then commercialize the product. The key elements of Veloxis’ business strategy are as follows:
The Company intends to continue the development programme aiming at NDA/MAA submission and commercial launch, 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.
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 LCP-Tacro in certain countries, including Europe, Turkey and CIS Countries.
In April 2013, Veloxis submitted a marketing authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval to market LCP-Tacro for the prevention of organ rejection in kidney transplant patients in the European Union.