HORSHOLM, Denmark, March 3, 2015 /PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO) ('Veloxis') today published the annual report of Veloxis Pharmaceuticals A/S for the financial year 2014. The annual report has been prepared in accordance with International Financial Reporting Standards as adopted by the EU and additional Danish disclosure requirements for annual reports of listed companies.
This company announcement should be read in conjunction with Veloxis' annual report 2014 published separately today.
Full Year 2014 Highlights
- Filed an action against the FDA, seeking an order requiring FDA to grant final approval to Envarsus® XR.
- FDA has informed Veloxis of a 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.
- The European Commission (EC) has granted marketing authorization for Envarsus® for the prevention of organ rejection in adult kidney and liver transplant patients in the European Union (EU).
- Once-daily Envarsus® XR (tacrolimus extended-release tablets), demonstrated a lower treatment failure rate in African-Americans compared with twice-daily tacrolimus (Prograf®).
- Two-year results of the pivotal Phase 3 clinical trial, Study 3002, of Envarsus® XR (tacrolimus extended-release tablets) in de novo kidney transplant patients continued to demonstrate non-inferiority compared to tacrolimus capsules (Prograf®; Astellas Pharma).
- The FDA has accepted for standard review the company's New Drug Application (NDA) for Envarsus® for the prevention of organ rejection in adult kidney transplant patients.
- United States Patent and Trademark Office had issued a Notice of Allowance for U.S. Application Serial Number 13/167,420, a patent which covers the diurnal-independent administration of Envarsus®.
- During 2014, Veloxis recognized revenue from deferred upfront, milestone payments and commercial sales of DKK 123.4 million compared to DKK 38.2 million in 2013.
- Sales and marketing costs amounted to DKK 41.3 million in 2014. This reflects the hiring and building of the marketing and sales infrastructure.
- Research and development costs decreased by DKK 56.4 million, or by 38.5%, from DKK 146.5 million in 2013 to DKK 90.1 million in 2014. Research and development costs are mainly attributable to the phase III trial in Envarsus® (de novo patients, Study 3002). The reduction in cost is associated with the overall reduction in study activity as some studies have now been completed.
- Administrative expenses increased from DKK 27.8 million in 2013 to DKK 47.4 million in 2014.
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