Veloxis Pharmaceuticals A/S
Envarsus® XR Demonstrates Differentiated Pharmacokinetic Profile Compared to Twice-Daily Prograf® or Once-Daily Astagraf XL® in Stable Kidney Transplant Patients

Veloxis Pharmaceuticals A/S 

24.06.2015 17:15

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Company Announcement no. 16/2015





To: NASDAQ OMX Copenhagen A/S                      Hørsholm, Denmark, June 24,
2015 





  Envarsus(R) XR Demonstrates Differentiated Pharmacokinetic Profile Compared to
  Twice-Daily Prograf(R) or Once-Daily Astagraf XL(R) in Stable Kidney Transplant
                                    Patients



Veloxis Pharmaceuticals A/S (OMX: VELO) today announced top-line results of the
ASTCOFF study, A STeady-state Pharmacokinetic COmparison Of all FK-506
Formulations, demonstrating 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, achieved
differentiated pharmacokinetics (PK) when compared to twice-daily tacrolimus
(Prograf(R)) or a once-daily tacrolimus product (Astagraf XL(R)). 



ASTCOFF is the first pharmacokinetic study to compare all three of these
branded formulations of tacrolimus and is a two-sequence, three-period
crossover study, designed to compare the steady-state PK profiles of Envarsus
XR tablets (Veloxis Pharmaceuticals Inc., New Jersey, USA), Astagraf XL
(Astellas Pharma US, Inc., Northbrook, IL) capsules administered once-daily and
Prograf capsules (Astellas Pharma US, Inc., Northbrook, IL) administered
twice-daily in stable renal transplant patients.  Patients were dosed with each
drug for seven days and blood samples were obtained over 24 hours to obtain
pharmacokinetic data. 



This study confirmed previously published data for Envarsus and showed greater
bioavailability (p<0.0001) and a flatter PK profile characterized by lower
peak-to-trough fluctuation (p<0.001) and delayed time to peak concentrations of
6 hrs (p=<0.001) compared to both Prograf and Astagraf. At equivalent exposure,
Envarsus achieves at least a 30% dose reduction requirement and a substantively
lower peak blood concentration (p=<0.005) compared to the two comparator
products. 



'This novel scientifically rigorous study design implemented by Dr. Simon
Tremblay and our team demonstrates that there are potentially clinically
meaningful differences between tacrolimus formulations and provides results to
transplant clinicians that can be directly applied to patient management.' said
Rita Alloway, PharmD, Research Professor of Medicine, University of Cincinnati
Medical Center. 



'The results from ASTCOFF provide additional evidence of the differentiated PK
profile of Envarsus XR and will provide further guidance on how best patients
can be switched to Envarsus,' said William Polvino, M.D., chief executive
officer of Veloxis. 'We look forward to providing Envarsus XR as an option to
transplant patients in the near future.' 



For Investor and media contact:

John Weinberg, M.D.                          Johnny Stilou

EVP & COO                                         EVP & CFO

Phone: +1 732 321 3208                     Phone: + 45 30 53 33 64

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



24.06.2015 The DGAP Distribution Services include Regulatory Announcements,
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Language:     English
Company:      Veloxis Pharmaceuticals A/S
              
               
              Denmark
Phone:        
Fax:          
E-mail:       
Internet:     
ISIN:         DK0060048148
WKN:          
 
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