Veloxis is a speciality pharmaceutical company focused on the development of Envarsus® (LCP-Tacro) for the prevention of organ rejection in kidney transplant patients and subsequent commercialization.
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, and it intends to proceed with an NDA submission in the United States in the second half of 2013.
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.