Company Announcement no. 1/2012



To: NASDAQ OMX Copenhagen A/S
Hørsholm, Denmark, January 4, 2012



Veloxis Pharmaceuticals Announces Initiation of STRATO Study of LCP-Tacro™ in
Kidney Transplant Recipients Experiencing Tremors


Veloxis Pharmaceuticals A/S (OMX: VELO) today announced dosing of the first
patient in the STRATO (Switching kidney TRAnsplant patients with Tremor to
LCP-tacrO) Phase IIIb 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.


Drug-induced tremor is a concerning side effect experienced by almost half of
transplant patients taking twice-daily tacrolimus, the current standard of care
therapy. Evidence suggests that tacrolimus-induced tremor is related to peak
concentration levels that usually occur approximately two hours after dosing.
LCP-Tacro™, currently in Phase III development for prophylaxis of rejection in
kidney transplant recipients, utilizes Veloxis’ proprietary extended release
formulation based on the MeltDose® technology, which offers once-daily
administration and a flatter pharmacokinetic profile. This characteristic is
postulated to be potentially beneficial in mitigating peak-related neurotoxic
effects of tacrolimus.


“We believe this is the first trial in kidney transplant recipients that will
utilize a sophisticated and reproducible measurement of tremor,” said Dr.
Anthony J. Langone, M.D., Assistant Professor of Medicine at Vanderbilt
University Medical Center. ”This study will determine if renal transplant
patients who currently experience tremors have a measurable reduction in
symptoms after conversion to LCP-Tacro™, while maintaining comparable drug
exposure. In addition to improving tremor symptoms and quality of life in
patients with tremors, LCP-Tacro™ may obviate the need for dose-reductions and
address compliance issues that may stem from experiencing neurotoxicity related
to tacrolimus.”


STRATO Study Design


Patients experiencing tacrolimus-related neurotoxicity, as demonstrated by
moderate-to-severe tremors, on immediate release tacrolimus products, will be
enrolled in this Phase IIIb study of kidney transplant recipients. Patients
will be converted to once-daily LCP-Tacro™ and their neurotoxicity symptoms
assessed using the Fahn-Tolosa-Marin tremor rating scale, as well as by
tremorometer readings. Quality of life assessments will also be undertaken to
determine the level of improvement during the study.


For information about the study, please visit www.clinicaltrials.gov, clinical
trials identifier NCT01438710.


For more information, please contact:

Veloxis Pharmaceuticals A/S
John Weinberg, M.D.
SVP, Commercial Operations & Investor Relations
Phone: +1 732 321 3208
Email: [email protected]


About LCP‐Tacro™ and tacrolimus


Tacrolimus is a leading immunosuppression drug used for the prevention of
transplant allograft rejection after organ transplantation. LCP‐Tacro™ is being
developed as a once‐daily tablet version of tacrolimus, with improved
bioavailability, consistent pharmacokinetic performance and reduced
peak‐to‐trough variability when compared to currently approved tacrolimus
products. Transplant patients need to maintain a minimum blood level of
tacrolimus for the prevention of transplant allograft rejection, but excessive
levels may increase the risk of serious side effects such as nephrotoxicity and
opportunistic infections. Therefore, tacrolimus levels need to be managed
carefully, and transplant patients are typically obliged to make frequent
visits to the hospital for monitoring and dose adjustments after receiving a
new organ.


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.

040112 Veloxis Announces Initiation of STRATO study.pdf