Veloxis Pharmaceuticals A/S
Envarsus® XR Demonstrates Improved Pharmacokinetic Profile in African-American Transplant Recipients

Veloxis Pharmaceuticals A/S 

04.05.2015 08:30

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Company Announcement no. 12/2015





To: NASDAQ OMX Copenhagen A/S                      Hørsholm, Denmark, 4 May 2015





 Envarsus(R) XR Demonstrates Improved Pharmacokinetic Profile in African-American
                              Transplant Recipients

                                        

               Data presented at the American Transplant Congress



Veloxis Pharmaceuticals A/S (OMX: VELO) today announced that once-daily
Envarsus(R) XR (tacrolimus extended-release tablets), an investigational new drug
under FDA review for the prevention of organ rejection in adult kidney
transplant patients, 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 twice-daily immediate
release tacrolimus.  These data, which are from one of the largest trials of
tacrolimus pharmacokinetics (PK) in African-American kidney transplant patients
conducted to date, were presented at the American Transplant Congress (ATC) on
May 3, 2015, in Philadelphia, in a presentation entitled 'PK and
Pharmacogenomics of Once-daily MeltDose(R) Tacrolimus (Envarsus(R) XR) vs.
Twice-daily Tacrolimus: A Randomized Cross-over Study in Stable
African-American Kidney Transplant Patients (ASERTAA)'. There are several
additional presentations on Envarsus XR at ATC, which are listed below. 



African-Americans can be a challenging patient population for managing immune
suppression, with historically poorer outcomes. Expression of the CYP3A5*1
genotype, which codes for a cytochrome p450 enzyme that metabolizes tacrolimus,
was shown to be present in approximately 80% of African-Americans and that
genotype commonly requires higher tacrolimus doses to obtain and maintain
therapeutic levels of tacrolimus. Higher tacrolimus dosing has the potential to
increase the risk of tacrolimus-associated adverse events. This study evaluated
the PK profile of once-daily Envarsus(R) XR compared to twice-daily or
immediate-release tacrolimus (IR-Tac) in this patient population. 



  -- The overall PK differences (increased absorption [p<0.0001], lower peak
     blood concentrations [p<0.0001], less peak-to-trough 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.
  -- 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.



'The data seen in this study suggest that African-American patients treated
with Envarsus are able to reliably achieve adequate blood levels at a lower
dose than with traditional immediate-release tacrolimus and that they will not
experience as high a peak blood level during the day,' said Roy D. Bloom, M.D.,
Professor of Medicine, University of Pennsylvania and Medical Director of the
Penn Kidney Pancreas Transplant Program. 'Envarsus may offer an important
additional therapeutic option in our management of this traditionally
hard-to-treat transplant population.' 



'We developed Envarsus XR to be a formulation of tacrolimus that has an
improved PK profile to both assist in the management of transplant patients and
potentially impact their quality of life,' said William Polvino, M.D.,
president and chief executive officer of Veloxis. 'We are very excited with the
results from this study that demonstrate that the pharmacokinetic performance
differences of Envarsus XR previously seen have now been demonstrated in this
focused study of African-American transplant patients.' 



  -- Presentations on Envarsus XR accepted for presentation:
     -- Abst.343, 5:30 PM, Sunday, May 3rd, 2015/Exhibit Hall E 

Comparison of Pharmacokinetics and Pharmacogenomics of Once-daily
Extended-release MeltDose(R) Tacrolimus Tablets (Envarsus(R) XR) vs. Twice-daily 

Immediate-release Tacrolimus Capsules in Stable African American Kidney
Transplant Patients: A Randomized Cross-over Study 

J. Trofe-Clark, PharmD; D. Brennan, MD; P. West-Thielke, Pharm; M. Milone, MD,
PhD; M. Lim, MD; R. Bloom, MD 



  -- Abst.256, 5:30 PM, Sunday, May 3rd, 2015/Exhibit Hall E 

A Randomized Cross-over Phase IIIb Study of the Pharmacokinetics of Once-daily
Extended-release MeltDose(R) 

Tacrolimus (Envarsus(R) XR) Versus Twice-daily Immediate-release Tacrolimus in
African Americans (ASERTAA) 

J. Trofe-Clark, PharmD; D. Brennan, MD; P. West-Thielke, PharmD; M. Milone, MD,
PhD; M. Lim, MD; R. Bloom, MD 



  -- Abst.405, 5:30 PM, Sunday, May 3rd, 2015/Exhibit Hall E .

Improved Bioavailability and Reduced Dose Requirements of Novel, Once-daily,
MeltDose(R) Tacrolimus Formulation Tablets (Envarsus(R) XR) 

Compared to Twice-daily Tacrolimus Capsules (Prograf(R)) in De Novo Kidney
Transplantation: Results of a Phase 3, Double-Dummy, Randomized Trial 

J. Grinyó, MD; S. Bunnapradist, MD; S. Mulgaonkar, MD; S. Steinberg, MD



  -- Abst.314, 5:30:, Sunday, May 3rd, 2015/Exhibit Hall E .

Lipid Profiles over 2 Years Follow-up in De Novo Kidney Transplant Recipients
Randomized to Once-daily MeltDose(R) Tacrolimus (Envarsus(R) XR) Vs. 

Twice-daily Tacrolimus (Prograf(R)): Results from a Phase 3, Double-blind,
Double-dummy, Multicenter Trial 

S. Mulgaonkar, MD; O. Pankewycz, MD; S. Steinberg, MD FACP FASN



  -- Abst.332, 5:30 PM, Sunday, May 3rd, 2015/Exhibit Hall E .

Efficacy, Safety and Pharmacokinetics of Once-daily, MeltDose(R) Tacrolimus
(Envarsus(R) XR) Versus Twice-daily Tacrolimus (Prograf(R)) in De Novo Kidney 

Transplant Recipient Sub-groups: A 2 Year Phase 3 Randomized, Double-blind,
Double-dummy, Trial 

S. Bunnapradist, MD; J. Denny, MD; M. Waybill, MD; P. West-Thielke, Pharm; S.
Steinberg, MD, FACP, FASN 



For Investor and media contact:

John Weinberg, M.D.                            Johnny Stilou

EVP & COO                                          EVP & CFO

Phone: +1 908 304 3389                      Phone: + 45 30533364

Email: jdw@veloxis.com                        Email: jst@veloxis.com



About Envarsus(R) XR

Envarsus(R) (tacrolimus prolonged-release tablets) has received marketing
authorization in the EU for prophylaxis of organ rejection in kidney and liver
transplant recipients. In the US, Envarsus(R), known as Envarsus(R) XR (tacrolimus
extended-release tablets), has received Tentative Approval as a once-daily
tablet version of tacrolimus for prophylaxis of organ rejection in kidney
transplant patients in combination with other immunosuppressants.  Envarsus(R) XR
has received orphan drug designation in the U.S. Veloxis plans to commercialize
Envarsus(R) XR in the US through its own sales force and in the EU through its
partnership with Chiesi Farmaceutici SpA. 



About Veloxis Pharmaceuticals

Based in Hørsholm, Denmark, with an office in New Jersey, Veloxis
Pharmaceuticals A/S, or Veloxis, is a specialty pharmaceutical company.
Veloxis' unique, patented delivery technology, MeltDose(R), is designed to
enhance the absorption and bioavailability of select orally administered drugs.
Veloxis is listed on the NASDAQ OMX Copenhagen under the trading symbol OMX:
VELO. 

For further information, please visit www.veloxis.com.
News Source: NASDAQ OMX



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Company:      Veloxis Pharmaceuticals A/S
              
               
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