The primary goal of Veloxis is to obtain regulatory approval and commercialize our late stage development candidate Envarsus® XR (tacrolimus extended-release tablets) (formerly LCP- Tacro™) in the US, to support commercial efforts of our partner to sell Envarsus® in the EU and to seek further registration and partnering efforts in other regions. The key elements of Veloxis’ business strategy are as follows:
Obtain regulatory approval for Envarsus® within the organ transplantation area
Envarsus® (tacrolimus prolonged-release tablets) has received marketing authorization in the EU for prophylaxis of organ rejection in kidney and liver transplant recipients.
In the US, Envarsus® XR (tacrolimus extended-release tablets), has received Tentative Approval as a once-daily tablet version of tacrolimus for prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants. FDA stated that the final approval of Envarsus® XR will be delayed until expiration of the exclusivity period for Astellas’ Astagraf XL®. Veloxis understands that this expiry is anticipated to occur 19 July, 2016. Veloxis disagrees that exclusivity for Astagraf XL® should require delay in the full approval of Envarsus® XR and has filed a legal action against FDA, seeking an order requiring the FDA to grant immediate final approval to Envarsus® XR.
Envarsus® XR has received orphan drug designation in the U.S.
Commercialize Envarsus® in the US and partner outside of the US
Veloxis plans to commercialize Envarsus® in the US our self and through partnering arrangements in the rest of the world.
Veloxis has a partnership agreement with Chiesi in respect of the commercialization of Envarsus® in Europe, Turkey and CIS Countries. Chiesi has launched Envarsus® in several EU countries and will continue to roll out launches through 2015 and beyond.