The transplant marketplace in the US is ideally suited for a small and well-focused selling effort and the clinical practice of transplant medicine leads to a unique commercialization opportunity. Transplants are generally performed at a small number of highly specialized centres, of which there are approximately 250 in the entire US. Patients waiting for a transplant will often travel considerable distances for transplant at one of these few centres. As such, a limited number of sales representatives can cover the majority of the centres.
Upon receipt of regulatory approval, Veloxis plans to launch and commercialize Envarsus® in the US through its own dedicated sales representatives and to commercialize the product in the rest of the world via partnering arrangements. The required infrastructure build for the US is underway and will be completed as the Company nears projected launch. It is anticipated that a field sales force of approximately 20 representatives will be hired to call on the key transplant centres in the US.
Regulatory action from the FDA in response to the NDA filing in the US is anticipated to take place approximately one year after the submission date of December 2013, based on historic precedent.
In relation to other jurisdictions, the Company has recently concluded a partnership agreement with Chiesi in respect of the commercialization of Envarsus® in certain countries, including Europe, Turkey and CIS Countries. Regulatory action from the EMA on the EU MAA is anticipated for second half of 2014. Chiesi has a strong history of selling specialty products in the EU market and an extensive sales and distribution network.