HORSHOLM, Denmark, May 15, 2012 /PRNewswire/ --
Highlights:
- Enrolment has been completed in the pivotal LCP-Tacro 3002 Phase III study in de novo kidney transplant patients. The LCP-Tacro 3002 study is designed to demonstrate non-inferiority versus standard therapy Prograf® and randomized 543 patients at approximately 90 clinical sites around the world.
- Veloxis have initiated the STRATO Study of LCP-Tacro in Kidney Transplant Recipients Experiencing Tremors. The study is 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 LCP-Tacro tablets leads to a measurable improvement in tremor.
- Veloxis reported a net loss of DKK 75.0 million for the first quarter of 2012 compared to a net loss of DKK 65.8 million for the same period in 2011. The reported net loss is in line with expectations and the financial outlook for 2012 is maintained.
- For the first quarter of 2012, Veloxis' research and development costs amounted to DKK 62.8 million compared to DKK 52.3 million during the same period in 2011.
- On 31 March, 2012, Veloxis had cash and cash equivalents of DKK 213.8 million.
A conference call will be held tomorrow, 16 May, 2012 at 3:00 PM CET (Denmark); 2:00 PM GMT (London), 9:00 AM ET (New York), 6:00 AM PT (San Francisco).
To access the live conference call, please dial one of the following numbers:
+45 32 72 76 25 (Denmark)
+44 (0) 1452 555 566 (UK)
+1 631 510 7498 (USA)
Access code 77202811
Following the conference call, a recording will be available on the company's website http://www.veloxis.com.
Outlook for 2012
Veloxis maintains its 2012 outlook announced in the annual report for 2011, published in March 2012, with an operating loss of DKK 220250 million and likewise a net loss of DKK 220250 million. The Company's position of cash and cash equivalents as at 31 December, 2012 is expected to be in the range of DKK 4080 million.
Management is focused on securing additional funds beyond 2012 by either partner agreements, debt or equity, or a mix thereof.
Research & development update
LCP-Tacro in kidney transplant patients
Veloxis is completing two Phase III studies of LCP-Tacro in kidney transplant recipients, as the basis for its development programme for LCP-Tacro 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 this study 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 is being undertaken in de novo kidney transplant recipients. This study is a randomized, double-blind, multicenter study that compares once-daily LCP-Tacro against twice-daily Prograf® in de novo adult kidney transplant patients. The primary endpoint of the study, a composite endpoint (biopsy proven acute rejection, graft failure, loss to follow up or death), will be evaluated after a 12-month treatment period to demonstrate the non-inferiority of LCP-Tacro compared to Prograf®. Secondary endpoints will include safety, tolerability and renal function assessments. The study completed enrollment in March 2012 of 543 subjects at approximately 90 transplant centers, primarily in the U.S and Europe. Patients will participate in a 12-month extension period on treatment for follow-up safety assessments.
In addition to the pivotal Phase III studies, Veloxis is planning a series of Phase IIIb studies to further evaluate potential differences in clinical profile provided by LCP-Tacro's unique PK profile. The first study initiated is the STRATO (Switching kidney TRAnsplant patients with Tremor to LCP-tacrO) study of LCP-Tacro in kidney transplant recipients experiencing drug-induced tremors. The STRATO study is 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 LCP-Tacro tablets leads to a measurable improvement in tremor.
LCP-Tacro Regulatory Strategy
Based upon the favorable results of the 3001 Study, and the totality of an extensive Phase I, II and III clinical safety, efficacy and PK program, the company plans to file an MAA with the EMA mid-2012. The U.S. submission to the FDA will be based on data from Studies 3001 and 3002, as well as on data from Phase I and II studies, and is planned for the second half of 2013.
