Veloxis Pharmaceuticals A/S
U.S. District Court Rules in Veloxis Litigation

Veloxis Pharmaceuticals A/S 

12.06.2015 18:29

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Company Announcement no. 15/2015





To: NASDAQ OMX Copenhagen A/S                      Hørsholm, Denmark, 12 June
2015 





                U.S. District Court Rules in Veloxis Litigation

                                        

    U.S. District Court rules that Envarsus(R) XR is blocked in de novo setting

             Veloxis submits labeling for use in conversion setting

                                        

Veloxis Pharmaceuticals A/S (OMX: VELO) today announced that the U.S. District
Court for the District of Columbia ruled in favor of the U.S. Food and Drug
Administration (FDA) in the lawsuit filed by Veloxis against FDA.  The Court's
ruling leaves intact FDA's October 30, 2014 tentative approval of Envarsus XR
(tacrolimus extended-release tablets), which delays full approval for use in
newly transplanted kidney transplant recipients ('de novo' patients).  Veloxis
has today submitted revised labeling to FDA with the goal of making Envarsus XR
available as soon as possible for kidney transplant patients who wish to
convert from twice-daily tacrolimus products to once-daily Envarsus XR. Veloxis
expects its amendment to the labeling to be a Class 1 labelling change to the
Envarsus XR NDA and subject to a 2-month PDUFA target timeline for FDA review. 
With an expected 2-month labeling review timeline, Veloxis plans to launch in
the conversion segment in 4Q2015 following successful labeling review and
approval by the FDA.  PDUFA timelines are internal targets for the FDA and are
not binding commitments.  The actual review timeline may be shorter or longer
than the target.  Approval in the de novo setting will be delayed until
expiration of the exclusivity period for Astellas' Astagraf XL(R) which will
occur in July 2016, or Jan 2017 if pediatric exclusivity extension is awarded
to Astellas. 


'Today's court ruling has provided the needed clarity on the initial label
indication for Envarsus XR in the U.S.,' said William Polvino, M.D., president
and chief executive officer of Veloxis.  'With this uncertainty now removed,
Veloxis looks forward to making Envarsus XR available in the appropriate
patient segments in the U.S. as soon as possible. We believe that a more
focused claim for treating conversion patients with Envarsus XR will be a path
toward approval as soon as the fourth quarter of 2015. With launch, we will
begin educating U.S. physicians on the benefits of Envarsus XR to manage their
stable conversion patients.' 



Currently there are approximately 180,000 patients comprising the conversion
population.  There are approximately 17,000 new 'de novo' patients transplanted
each year. 



For more information, please contact:

Veloxis Pharmaceuticals A/S

John Weinberg, M.D.

EVP & Chief Operating Officer

Phone: +1 732 321 3208

Email: jdw@veloxis.com



About Envarsus(R)

Tacrolimus is a leading immunosuppression drug used for the prevention of
transplant allograft rejection after organ transplantation. 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



12.06.2015 The DGAP Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de

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Language:     English
Company:      Veloxis Pharmaceuticals A/S
              
               
              Denmark
Phone:        
Fax:          
E-mail:       
Internet:     
ISIN:         DK0060048148
WKN:          
 
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