HORSHOLM, Denmark, Nov. 12, 2014 /PRNewswire/ --
Highlights:
- On 31 October the U.S. Food and Drug Administration has 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. Veloxis is appealing the FDA decision.
- The European Commission has in July 2014 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 has received a milestone payment of USD 15 million from our European partner Chiesi in the third quarter 2014. The payment is recognized fully as income in the third quarter 2014.
- Veloxis reported a net profit of DKK 12.9 million for the first nine months of 2014 compared to a net loss of DKK 114.6 million for the same period in 2013. The reported net result is in line with expectations and the financial outlook for 2014 is maintained.
- For the first nine months of 2014, Veloxis’ research and development costs amounted to DKK 70.4 million compared to DKK 117.0 million during the same period in 2013.
- On 30 September, 2014, Veloxis had cash and cash equivalents of DKK 310.6 million.
- The full year outlook for 2014 is improved. Veloxis now expects an operating loss in the range of DKK 40 - 70 million, and a net loss in the range of DKK 20 - 50 million. Veloxis’ cash position is expected to be in the range of DKK 255 - 285 million at year-end 2014.
Outlook for 2014
The full year outlook for 2014 is improved. Veloxis now expects an operating loss in the range of DKK 40 - 70 million, and a net loss in the range of DKK 20 - 50 million
The improvement is driven by lower clinical study costs and delayed cost in the US sales and marketing infrastructure.
Cash and cash equivalents are expected to be in the range of DKK 255 - 285 million at 31 December 2014. This compares with expectations of DKK 230 270 million announced in connection with the annual report for 2013.
Conference call
A conference call will be held tomorrow, 13 November, 2014 at 3:00 PM CET (Denmark); 2:00 PM GMT (London), 9:00 AM EST (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 28069222
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. On 30 October, 2014 the FDA granted Tentative Approval for Envarsus® XR for the prophylaxis of rejection in kidney transplant patients. 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 19 July, 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.” Veloxis disagrees that exclusivity for Astagraf XL, which was not identified as a listed drug or relied upon to support approval of Envarsus XR, should require delay in the formal approval of Envarsus XR. Veloxis plans to appeal this decision within FDA.
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