Company Announcement no. 12/2011



To: NASDAQ OMX Copenhagen A/S Hørsholm, Denmark,
September 6, 2011



Veloxis Pharmaceuticals' Once-Daily LCP-Tacro™ Meets Non-Inferiority Endpoint
When Compared to Twice-Daily Tacrolimus Tablets in Stable Kidney Transplant
Patients



Phase 3 Efficacy Results to be Presented at 15th Congress of the European
Society for Organ Transplantation (ESOT)



Hørsholm, Denmark, September 6, 2011 - Veloxis Pharmaceuticals A/S (OMX: VELO),
formerly LifeCycle Pharma A/S, today announced that efficacy results from its
Phase 3 study in stable kidney transplant patients suggests that its once-daily
LCP-Tacro™ is non-inferior in efficacy compared to twice-daily standard
tacrolimus tablets (Prograf®). Data will be presented in a rapid oral and
poster presentation at 4:08 p.m. BST, Tuesday, September 6, at the 15th
Congress of the European Society for Organ Transplantation (ESOT) in Glasgow,
United Kingdom.


”Coupled with previously reported pharmacokinetic parameters, efficacy results
from this Phase 3 trial suggest that LCP-Tacro may provide an alternative to
twice-daily tacrolimus,” said Prof Lionel Rostaing M.D., Ph.D., head of the
Organ Transplant Unit at Toulouse University Hospital, France. ”Further testing
will focus on the frequency of dose adjustments, the incidence of adverse
events, and potential patient compliance benefits.”


The Phase 3 trial was an open-label, multicenter, prospective, randomized study
enrolling 324 kidney transplant recipients 3-60 months post-transplant taking
oral Prograf®. Patients were randomized to receive LCP-Tacro once-daily or to
maintain their Prograf® regimen for 12 months. The primary efficacy endpoint
was a composite of death, graft failure, biopsy-proven acute rejection (BPAR)
via a local pathology reading or loss to follow-up within 12 months of
randomization. Initial LCP-Tacro dose was 30% lower (15% for African Americans)
than the pre-conversion Prograf® total daily dose. Trough levels of 4-15 ng/mL
were targeted for both drugs.


The primary composite treatment failure endpoint was met by 4 patients (4.2
percent) in each group, p>0.999. As measured by the central blinded
pathologist, the rates of BPAR were 0.6% for LCP-Tacro and 3.1% for Prograf®
(p=0.214). LCP-Tacro patients, on average, required a daily dose that was 20%
lower than patients receiving Prograf®, reflecting the improved absorption
provided by Veloxis' proprietary MeltDose® formulation.


”The positive data from this trial suggest that LCP-Tacro may provide efficacy
matching twice-daily tacrolimus but at a lower dose and using a once-daily
dosing regimen,” said William Polvino, M.D., chief executive officer of
Veloxis. ”Our second Phase 3 trial in de novo kidney transplant patients is
ongoing and we expect to report results from that trial by the first quarter of
2013.”







For more information, please contact:



Veloxis Pharmaceuticals A/S
John Weinberg, M.D.
SVP, Commercial Operations & Investor Relations
Phone: +1 908 304 3389
Email: [email protected]

About Veloxis Pharmaceuticals


Based in Hørsholm, Denmark, with an office in New Jersey, Veloxis
Pharmaceuticals A/S, or Veloxis, is a specialty pharmaceutical company.
Clinical development is the core of Veloxis' efforts to develop a product
portfolio which includes the Company's lead product candidate, LCP‐Tacro™, for
immunosuppression, specifically organ transplantation, and products to combat
certain cardiovascular diseases. Veloxis adapts new technologies on a fast
commercial timetable. Veloxis' unique, patented delivery technology, MeltDose®,
can improve absorption and bioavailability ‐ at low‐scale up costs ‐ not only
for a broad spectrum of drugs already on the market but also for new chemical
entities. Veloxis has a lipid lowering product, Fenoglide®, currently on the
U.S. market and a diversified near and medium term pipeline with three clinical
stage product candidates and a number of projects in preclinical development.
Veloxis is listed on the NASDAQ OMX Copenhagen under the trading symbol OMX:
VELO.


For further information, please visit www.veloxis.com.

060911 - Veloxis Announces Once-Daily LCP-TacroTM Meets Non-Inferiority Endpoint.pdf