Investor service announcement no. 8/2011



To: NASDAQ OMX Copenhagen
Hørsholm, Denmark, November 10, 2011





Veloxis Pharmaceuticals Presents LCP-Tacro(TM) Phase 3 Data at the American
Society of Nephrology Annual Meeting



Veloxis Pharmaceuticals A/S (OMX: VELO) today will present detailed blinded
central pathology (biopsy) results from the LCP-Tacro(TM) study 3001 a
long-term safety and efficacy switch study of LCP-Tacro(TM) in kidney
transplant recipients, at the Society of Nephrology (ASN) Kidney Week Annual
Scientific Meeting. Topline results of this study were released in June 2011.
The results presented today show that LCP-Tacro(TM) once-daily was associated
with a trend towards reduction in the incidence of Biopsy Proven Acute
Rejection (BPAR) and a tendency for less severe histological changes compared
to Prograf® twice-daily.

LCP-Tacro(TM) Data Presented

35 needle biopsies (23 LCP-Tacro(TM), 12 Prograf®) were centrally read by one
pathologist blinded to treatment assignment. 1 BPAR episode was recorded for 1
LCP-Tacro(TM) patient, vs. 7 BPAR episodes in 5 Prograf® patients (5 unique
Prograf® patients with 1 BPAR each; 2 patients had 2 episodes each) (p=0.21).
All BPARs were mild; however, BANFF chronicity score tended to be greater in
the Prograf® group (LCP-Tacro(TM) = 2, n=1; Prograf® mean = 3.6, n=5). Overall,
1 of 162 patients randomized to receive LCP-Tacro(TM) therapy (0.62%) and 5/162
patients randomized to receive Prograf® treatment (3.1%) in the modified
intent-to-treat population had ≥ 1 centrally read BPAR (p=0.215).


Using blinded central pathology readings and including all data reported during
the study prior to database lock, the composite primary efficacy endpoint
(treatment failures) was met by 4 patients in the LCP-Tacro(TM) group vs. 8
patients in the Prograf® group, p=0.38; treatment difference (95% confidence
interval): -2.47% (-7.5, +1.9). The composite primary efficacy endpoint
consisted of death, graft loss, BPAR and lost to follow up. The 4 LCP-Tacro(TM)
treatment failures included 3 deaths and 1 BPAR. The 8 Prograf® treatment
failures included 1 death, 1 graft loss, 5 BPAR and 1 lost to follow up.


LCP-Tacro(TM) enabled a reduction in dose of 20% through 12 months following a
switch from Prograf® as measured by median tacrolimus dose (mg/kg/day)
(p<0.00001). Mean tacrolimus trough levels throughout the study were comparable
and within the 4-15 ng/mL protocol-specified target range for both groups.
Tacrolimus trough levels preceding each BPAR were within the protocol-specified
4-15 ng/mL target range. Mean GFR tended to be higher for the LCP-Tacro(TM)
group.


These results are consistent with previous clinical studies and PK results that
demonstrated higher bioavailability (LCP-Tacro(TM) patients, on average,
required a daily dose that was 20% lower than patients receiving Prograf®,
reflecting the improved absorption provided by the MeltDose® formulation) and
comparable efficacy versus Prograf® on predefined endpoints.


“The results we have seen in this Phase III study suggest that LCP-Tacro(TM)
is non-inferior to Prograf® in the predefined primary endpoints when
LCP-Tacro(TM) is dosed at once a day,” said Dr. Suphamai Bunnapradist, M.D.,
Professor of Medicine and Director of Kidney Transplant Research at the Ronald
Reagan Medical Center and David Geffen School of Medicine at UCLA, California,
USA., “These data concerning rejection rates, although small and not
sufficiently powered to be clinically meaningful, are promising and offer new
avenues for additional research and possible submissions to FDA.”



For more information, please contact:



John Weinberg, M.D. Johnny Stilou
SVP, Commercial Operations & Investor Relations Chief Financial Officer
Tlf: +1 908 304 3389 Tlf: +45 2055 3852
Email: [email protected] Email: [email protected]


Veloxis Pharmaceuticals A/S (VELO)

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(TM)
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.

101111 Veloxis Pharmaceuticals Presents LCP-Tacro™ Phase 3 Data at the American Society of Nephrology Annual Meeting.pdf