Talk to a D&B Advisor
1-800-280-0780
  1. Business Directory
  2. NJ
  3. Edison
  4. Pharmaceutical Preparations
  5. Pharmaceutical Preparations
  6. Veloxis Pharmaceuticals, Inc.

Veloxis Pharmaceuticals, Inc.

CLAIM THIS BUSINESS

499 THORNALL ST FL 3 EDISON, NJ 08837 Get Directions

(732) 321-3224

www.veloxis.com

Business Info

  • Founded 2007
  • Incorporated NJ
  • Annual Revenue $18,584,272.00
  • Employee Count 35
  • Industries Pharmaceutical Preparations
  • Contacts Bill Polvino

Contact Business

Send Message

Company Summary

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.

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.

VERIFIED Status: VERIFIED
Address:
UNVERIFIED
LAST VERIFIED: 8 - 6 - 2015
Phone:
VERIFIED
Payment Method:
UNVERIFIED
view full report

Similar Businesses Nearby

Our similar businesses nearby shows similar businesses in their industry and region based on information found in their Dun & Bradstreet Credibility Review profile.

    Competitive Landscape

    Our competitive landscape shows how this business compares to similar businesses in their industry and region based on information found in their Dun & Bradstreet Credibility Review profile.

      Payments Accepted

        NO DATA

      Hours

      • Sunday  --
      • Monday  --
      • Tuesday  --
      • Wednesday  --
      • Thursday  --
      • Friday  --
      • Saturday  --
      VIEW ADDITIONAL DATA Select from over 115 networks below to view available data about this business. If this data is unavailable or inaccurate and you own or represent this business, click here for more information on how you may be able to correct it.

      Business Credit Report

      Receive a one-time comprehensive credit report on this company.
      get full credit report
      Chat With Us LiveCall 1.800.280.0780 to speak with a D&B Advisor Today!