Veloxis is a speciality pharmaceutical company focused on the development and commercialization of Envarsus® (LCP-Tacro) for the prevention of organ rejection in kidney transplant patients.
Envarsus® is a once-daily dosage version of tacrolimus, the market-leading primary immunosuppressant in the transplant market, and has successfully demonstrated non-inferiority compared to Prograf® in its two Phase III clinical trials, Study 3001 (stable kidney transplant patients) and Study 3002 (de novo kidney transplant patients).
In April 2013, the company 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.
In December 2013, the company submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of Envarsus® for the prevention of organ rejection in kidney transplant recipients. The submission is based on the entire data set from the company's clinical development program that comprised 25 studies and enrolled over 1000 patients, including two pivotal clinical trials, studies 3001 and 3002. At the same time, Envarsus® was granted Orphan Drug status by the FDA for prophylaxis of organ rejection in patients receiving allogenic kidney transplants.
In October 2014, Veloxis announced that the FDA had informed Veloxis of the tentative approval of Envarsus® XR. 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 July 19, 2016. FDA's approval notice stated that it is "subject to change on the basis of any new information that may come to FDA's attention."
In December 2014, Veloxis announced that it has filed an action against the FDA, seeking an order requiring FDA to grant final approval to Envarsus® XR.
The company is using its proprietary MeltDose technology in the formulation of Envarsus® to enhance the bioavailability of the drug and allow for a sustained or modified release plasma profile. The MeltDose technology has been validated in clinical studies through FDA approval of Fenoglide (now on the market) for the treatment of dyslipidemia in adults.
Veloxis was founded in June 2002 as a spin-off from H. Lundbeck A/S and is listed on NASDAQ OMX Copenhagen A/S (OMX: VELO). Veloxis is an international company with headquarters in Hørsholm, Denmark, and a fully owned subsidiary in New Jersey, U.S.