HORSHOLM, Denmark, Aug. 20, 2014 /PRNewswire/ --
- On 28 July the European Commission granted marketing authorization for Envarsus® for the prevention of organ rejection in adult kidney and liver transplant patients in the European Union (EU).
- Following the European marketing authorization Veloxis will receive a milestone payment of USD 15 million from our European partner Chiesi in the third quarter 2014 which is in line with expectations. The payment will be recognized fully as income in the third quarter 2014.
- Envarsus® XR for the prevention of organ rejection in kidney transplant patients is under regulatory review by the U.S. FDA and has a PDUFA action date of October 30, 2014.
- The once-daily Envarsus® XR (tacrolimus extended-release tablets), an investigational new drug under FDA review for the prevention of organ rejection in adult kidney transplant patients, has demonstrated a lower treatment failure rate in African-Americans compared with twice-daily tacrolimus (Prograf®).
- The two-year results of the pivotal Phase 3 clinical trial, Study 3002, of Envarsus® XR in de novo kidney transplant patients continued to demonstrate non-inferiority compared to tacrolimus capsules (Prograf®; Astellas Pharma).
- Veloxis reported a net loss of DKK 53.1 million for the first half of 2014 compared to a net loss of DKK 80.5 million for the same period in 2013. The reported net loss is in line with expectations and the financial outlook for 2014 is maintained.
- For the first half of 2014, Veloxis' research and development costs amounted to DKK 51.0 million compared to DKK 81.7 million during the same period in 2013.
- On 30 June, 2014, Veloxis had cash and cash equivalents of DKK 264.2 million.
Outlook for 2014
Veloxis maintains its 2014 outlook with an operating loss of DKK 60-90 million and a net loss of DKK 55-85 million for the financial year 2014.
As at 30 June 2014, the Company's cash position equaled DKK 264.2 million, and as at 31 December 2014, the Company's cash position is expected to be in the range of DKK 230-270 million.
A conference call will be held tomorrow, 21 August, 2014 at 2:00 PM CET (Denmark); 1:00 PM BST (London), 8:00 AM EDT (New York).
To access the live conference call, please dial one of the following numbers:
+45 32 72 80 18 (Denmark)
+44 (0) 1452 555 131 (UK)
+1 866 682 8490 (USA)
Access code 89298792
Following the conference call, a recording will be available on the company's website http://www.veloxis.com.
Research & development update
Envarsus® in kidney transplant patients
Veloxis has conducted two Phase III studies of Envarsus® in kidney transplant recipients as the basis for its development programme for Envarsus® as a once-daily agent for the prophylaxis of organ rejection in kidney transplantation. The first of these studies, the 3001 Study, was a non-inferiority study performed in 326 stable kidney transplant recipients, and was successfully completed in 2011, meeting its primary efficacy and safety endpoints when compared to Prograf® (tacrolimus, Astellas Pharma Inc.). The second study, Study 3002 was a randomized, double-blind, multicenter study that compared once-daily Envarsus® against twice-daily Prograf® in 543 de novo adult kidney transplant patients and met its primary efficacy and primary safety endpoints. The primary endpoint of the study was a composite endpoint of treatment failure (biopsy-proven acute rejection, graft failure, loss to follow up or death) that was evaluated after a 12-month treatment period to demonstrate the non-inferiority of Envarsus® compared to Prograf®. The treatment failure rate for Envarsus® was 18.3% compared to 19.6% for Prograf®, and the difference between the treatments was well within the 10% pre-specified non-inferiority margin. The primary safety analyses were the differences between Envarsus® and Prograf® treatment groups at Month 12 (Day 360) with respect to the incidence of adverse events (AEs) and the incidence of predefined potentially clinically significant laboratory measures including: fasting plasma glucose; platelet count; white blood cell (WBC) count; aminotransaminases; total cholesterol; low density lipoprotein (LDL) cholesterol; triglycerides; and estimated glomerular filtration rate (eGFR). In all instances, there were no statistically significant differences between the two treatments. Specifically, renal function was similar between the two groups at 12 months, as was the incidence of malignancy, infections and new onset diabetes during this period. On June 29, 2014, Veloxis announced the results of the second year of blinded therapy in this study and the results were similar to the one-year results with Envarsus® continuing to demonstrate non-inferiority to Prograf® on the primary endpoint at the two year time point.
In addition to the pivotal Phase III studies, Veloxis is conducting a series of Phase IIIb/IV studies to further evaluate potential differences in clinical profile provided by Envarsus®' unique PK profile. The first study is the STRATO (Switching kidney TRAnsplant patients with Tremor to LCP-tacrO) study of Envarsus® in kidney transplant recipients experiencing drug-induced tremors. The STRATO study was designed to explore whether a conversion of patients who have symptomatic tremor from treatment with standard immediate release twice-daily tacrolimus capsules to extended release once-daily Envarsus® tablets leads to a measurable improvement in tremor. Results from this study demonstrated that patients switched to Envarsus® demonstrated a statistically significant improvement in hand tremors based on improvement in the FTM Tremor rating scale. Additionally, both the patient- and physician-reported global assessments demonstrated significant overall improvements following the switch to Envarsus®.
Additionally, the ASERTAA (A Study of Extended Release Tacrolimus in African-Americans) Phase IIIb study of Envarsus® in kidney transplant recipients is ongoing. The ASERTAA study is designed to compare the pharmacokinetics of Envarsus® given once-daily to generic twice daily tacrolimus capsules in stable African-American renal transplant patients. Results from this study are anticipated to be available in 2015.
Envarsus® Regulatory Strategy
On 29 April, 2013 a Marketing Authorization Application (MAA) was submitted by Veloxis to the European Medicines Agency (EMA) seeking approval to market Envarsus® for the prevention of organ rejection in transplant patients in the European Union. On 28 July, 2014, it was announced that the European Commission granted marketing authorization for Envarsus® for the prevention of organ rejection in adult kidney and liver transplant patients in the European Union (EU). The EU marketing authorization is based on review of the favourable results of the Envarsus® Phase III 3001 study in stable kidney transplant patients and 3002 study in de novo kidney transplant recipients as well as data from an extensive Phase I and II clinical program, which included both kidney and liver transplant patients.
Veloxis submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of Envarsus® in the US for the prevention of organ rejection in kidney transplant recipients on 30 December, 2013.
To read full press release, please click here.
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