Veloxis Pharmaceuticals A/S Announces Financial Results For The First Six Months Of 2015 And Improves The Full Year Outlook

HORSHOLM, Denmark, Aug. 26, 2015 /PRNewswire/ --

Highlights:

• On 14 August, 2015 Envarsus® XR was granted Orphan Drug status by the U.S. Food and Drug Administration (FDA) for prophylaxis of organ rejection in patients who convert from immediate-release tacrolimus.
• On 10 July, 2015 Veloxis has received U.S. Food and Drug Administration (FDA) approval of Envarsus® XR (tacrolimus extended-release tablets) for the prophylaxis of rejection in kidney transplant patients who require or desire conversion from other twice-daily tacrolimus products to once-daily Envarsus® XR. Veloxis expects Envarsus® XR to be available to patients in the United States and their physicians by the end of 2015.
• On 12 June, 2015 the U.S. District Court for the District of Columbia ruled in favor of the U.S. Food and Drug Administration (FDA) in the lawsuit filed by Veloxis against FDA. The Court's ruling left intact FDA's 30 October, 2014 tentative approval of Envarsus® XR (tacrolimus extended-release tablets), which delayed full approval for use in newly transplanted kidney transplant recipients ("de novo" patients). Veloxis submitted revised labeling to FDA on 12 June, 2015 with the goal of making Envarsus® XR available for kidney transplant patients who wish to convert from twice-daily tacrolimus products to once-daily Envarsus® XR.
• Top-line results of the ASTCOFF study was announced, A STeady-state Pharmacokinetic COmparison Of all FK-506 Formulations, which demonstrated that once-daily Envarsus® XR (tacrolimus extended-release tablets) exhibits a differentiated pharmacokinetic (PK) profile when compared to twice-daily tacrolimus (Prograf®) or the once-daily tacrolimus product (Astagraf XL®).
• Clinical study data was announced which demonstrated that a lower dose of once-daily Envarsus® XR in African-American kidney transplant patients is sufficient to achieve therapeutic tacrolimus blood concentrations, compared to the daily dose required for twice-daily immediate release tacrolimus, and also results in a lower peak concentration and intra-day fluctuation.
• Veloxis reported a net loss of DKK 66.1 million for the first half of 2015 compared to a net loss of DKK 53.1 million for the same period in 2014. The reported net loss is in line with expectations.
• For the first half of 2015, Veloxis' sales and marketing costs amounted to DKK 19.5 million compared to DKK 13.7 million during the same period in 2014. Research and development costs amounted to DKK 39.1 million compared to DKK 51.0 million during the same period in 2014.
• On 30 June, 2015, Veloxis had cash and cash equivalents of DKK 191.1 million.
• The full year outlook for 2015 is improved. Veloxis now expects an operating loss in the range of DKK 175 - 205 million, and a net loss in the range of DKK 155 - 185 million. Veloxis' cash position is expected to be in the range of DKK 100 - 130 million at year-end 2015.

Outlook for 2015
The full year outlook for 2015 is improved. Veloxis now expects a net loss in the range of DKK 155 - 185 million. This compares with expectations of DKK 195 - 235 million announced in connection with the annual report for 2014.

The improvement is driven by the granted Orphan Drug status which entitles Veloxis to a waiver of the FDA prescription drug user fees for Envarsus® XR, along with overall cost savings.

Cash and cash equivalents are expected to be in the range of DKK 100 130 million at 31 December 2015. This compares with previous expectations of DKK 55 95 million.

Conference call
A conference call will be held tomorrow, 27 August, 2015 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 38 48 75 13 (Denmark)
+44 (0) 20 3427 1909 (UK)
+1 646 254 3360 (USA)
Access code 9488658

Following the conference call, a recording will be available on the company's website http://www.veloxis.com.  

Business update
Envarsus® study program
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 completed was the STRATO (Switching kidney TRAnsplant patients with Tremor to LCP-tacrO) study of Envarsus® in kidney transplant recipients experiencing drug-induced tremors which 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 primary pharmacokinetic results were presented at the American Transplant Congress in Philadelphia on 3 May, 2015. Final data from this study will be presented at the European Society of Organ Transplantation meeting in September, 2015. The key primary outcomes from this study were:

• The overall PK differences (increased absorption [p<0.0001], lower peak blood concentrations [p<0.0001], less peak-to-tough fluctuation in blood levels [p<0.0001]) between Envarsus XR and IR-Tac capsules seen previously in studies of kidney transplant recipients were also confirmed in this exclusively African-American patient population.
• The optimal conversion ratio for once-daily extended release Envarsus XR was shown to be approximately 20% lower than the total IR-Tac daily dose prior to conversion.
• Peak tacrolimus concentration (Cmax) was reduced 30% for patients on Envarsus while intra-day fluctuation was reduced 50%.
• Envarsus XR's PK parameters were less impacted by CYP3A5 genotype. IR-Tac was more affected by the presence of the *1 allele, driven primarily by the need to increase dose to achieve therapeutic trough levels, which also resulted in an incremental increase in tacrolimus intra-day peak levels.
• Conversion of African-American patients from IR-Tac to Envarsus XR was demonstrated to be readily achieved with a reduction in dose of approximately 20% without concern for genotype status.

In addition, the ASTCOFF (A STeady-state Pharmacokinetic Comparison Of all FK-506 Formulations) Phase IIIb study is ongoing and primary results were announced in June, 2015. This study examines the pharmacokinetic differences between Envarsus and the other two tacrolimus formulations commercially available, namely Astagraf XL and Prograf. Primary results from this study confirmed previously published data for Envarsus and showed greater bioavailability (p<0.0001) and a flatter PK profile characterized by lower peak-to-trough fluctuation (p<0.001) and delayed time to peak concentrations of 6 hrs (p=<0.001) compared to both Prograf and Astagraf. At equivalent exposure, Envarsus achieves at least a 30% dose reduction requirement and a substantively lower peak blood concentration (p=<0.005) compared to the two comparator products. Final data from this study will be presented at the European Society of Organ Transplantation meeting in September, 2015.

Veloxis 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, Study 3001 in maintenance conversion kidney transplant patients and Study 3002 in de novo kidney transplant recipients.

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. The MAA submission was based on the favourable results of the Envarsus® Phase III 3001 Study in stable kidney transplant patients and data from an extensive Phase I and II clinical programme and has been accepted for review by the EMA.

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