Commercial strategy

The transplant marketplace in the United States 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 United States. 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. During a sales visit, a representative can effectively call upon all professionals involved in the transplant process, including surgeons, nephrologists, infectious diseases specialists and pharmacists. On a targeted basis, community nephrologists with large numbers of transplant patients would also be included for field force coverage.

Upon receipt of regulatory approval, Veloxis plans to launch and commercialize LCP-Tacro in the United States 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 United States is underway and will be completed as the Company nears projected launch in the fourth quarter of 2014.

It is anticipated that a field sales force of approximately 20 representatives will be hired to call on the key transplant centres in the United States in a tiered fashion, focusing on high priority centers performing the majority of transplants and covering these centres with a higher calling frequency than the lower priority centres. Around 140 of the approximately 250 transplant centres in the United States constitute high-prescribing centres. Consequently, a highly-skilled set of 20 sales representatives can effectively cover the small number of priority centers within the entire United States. The Company believes that these priority centers will be familiar with the attributes of LCP-Tacro by the time of launch, and many will have participated in clinical studies with Veloxis.

In relation to other jurisdictions, the Company has recently concluded a partnership agreement with Chiesi in respect of the commercialization of LCP-Tacro in certain countries, including Europe, Turkey and CIS Countries.