Novartis International AG : Alcon announces EU approval of Jetrea®, first and only eye drug to treat sight-threatening

Novartis International AG : Alcon announces EU approval of Jetrea®, first and
 only eye drug to treat sight-threatening vitreomacular traction and macular

Novartis International AG / Alcon announces EU approval of Jetrea®, first and
only eye drug to treat sight-threatening vitreomacular traction and macular
hole . Processed and transmitted by Thomson Reuters ONE. The issuer is solely
responsible for the content of this announcement.

  *Jetrea represents a breakthrough for patients with vitreomacular  traction 
    (VMT), a sight-threatening progressive condition, if left untreated[1]

  *One-time intravitreal  injection  of  Jetrea has  shown  efficacy  in  the 
    resolution of VMT and macular hole closure, compared to placebo at day  28 

Basel, March 18, 2013- Alcon, the global leader in eye care and a division  of 
Novartis,   announces   that    the   European    Commission   has    approved 
Jetrea^®intravitreal injection (ocriplasmin)  in the EU  for the treatment  of 
vitreomacular traction (VMT), including when  associated with macular hole  of 
diameter less than or  equal to 400 microns.[2]  VMT is often responsible  for 
progressive    sight-threatening    symptoms    and    irreversible     vision 
loss,[3],[4],[5],[6] and is  estimated to  affect between  250,000 to  300,000 
people in Europe alone.[7]

"The approval of Jetrea by the European Commission is a major breakthrough for
people with  VMT and  eye care  professionals who,  until now,  have only  had 
surgical options available to  treat this debilitating  eye disease. Now  they 
can intervene  early  with  a  one-time  injection  of  Jetrea,"  said  Stuart 
Raetzman, Area  President Europe,  Middle East  and Africa  at Alcon.  "Jetrea 
meets a  genuine unmet  patient need  and demonstrates  Alcon's commitment  to 
bringing innovative eye care treatments to people in Europe and throughout the

The pivotal studies, published in the New England Journal of Medicine,  showed 
that patients who were treated with Jetrea successfully achieved resolution of
VMT and closure of macular holes as  compared to placebo at day 28.[1] By  day 
28, 26.5%  of the  patients treated  with Jetrea  achieved resolution  of  VMT 
(versus 10.1% with placebo [P<0.001]).[1]  In addition, 40.6% of the  patients 
treated with Jetrea achieved closure of a macular hole by day 28 (versus 10.6%
with placebo [P<0.001]).[1]

Jetrea, a recombinant  form of  human protein (plasmin),  targets the  protein 
fibers which cause the abnormal pull  between the vitreous and the macula.  By 
dissolving these  proteins, Jetrea  separates the  vitreous from  the  macula, 
releasing VMT and helping to close the macular hole (if present).[2],[8]  This 
one-time injection  has  been  shown  to  provide  early  resolution  of  VMT, 
including when associated with macular hole of diameter less than or equal  to 
400 microns.[1],[2]

Side effects  observed  were  consistent  with the  release  of  traction  and 
intravitreal injections.  The  most  common  adverse  events  with  Jetrea  in 
clinical studies (>2%)  included: vitreous  floaters, photopsia,  conjunctival 
hemorrhage, injection-related eye pain, blurred vision, reduced visual acuity,
and retinal edema. These were generally  considered mild to moderate and  were 
resolved without complications.[1]

Alcon, a division  of Novartis,  acquired the rights  to commercialize  Jetrea 
outside  the  United  States   from  the  Belgian  biopharmaceutical   company 
ThromboGenics, which retains the rights to  commercialize the drug in the  US. 
In October 2012, Jetrea was approved in  the US for the treatment of  patients 
with  symptomatic  vitreomacular   adhesion  (VMA).  On   January  14,   2013, 
ThromboGenics launched Jetrea in the US.

About VMT including macular hole
As people get  older, the vitreous  (jelly-like material inside  the eye  that 
helps maintain  the  round shape)  detaches  naturally from  the  retina  (the 
light-sensitive layer  of  tissue located  at  the back  of  the  eyeball).[9] 
However, with  some people,  the vitreous  remains attached  to areas  of  the 
retina, particularly at  the macula (the  area of the  retina responsible  for 
central vision  needed  for  everyday  tasks  such  as  driving,  reading  and 
recognizing faces). This is known as vitreomacular adhesion.[9]These areas  of 
vitreomacular adhesion can exert a 'pulling force' on the macula, a  condition 
known as  vitreomacular  traction  (VMT).  VMT  may  eventually  lead  to  the 
formation of  a  hole in  the  macula.[2],[9]  VMT is  often  responsible  for 
progressive    sight-threatening    symptoms    and    irreversible     vision 

The  foregoing  release  contains  forward-looking  statements  that  can   be 
identified by terminology such as "can," "commitment," or similar expressions,
or by express or implied discussions regarding potential additional  marketing 
approvals for Jetreaor  regarding potential future  revenues from Jetrea.  You 
should not place  undue reliance  on these  statements. Such  forward-looking 
statements reflect the  current views of  management regarding future  events, 
and involve known and unknown risks, uncertainties and other factors that  may 
cause actual results  with Jetreato  be materially different  from any  future 
results, performance or achievements expressed or implied by such  statements. 
There can  be  no  guarantee that  Jetreawill  be  approved for  sale  in  any 
additional markets, or at any particular time. Nor can there be any  guarantee 
that Jetrea will achieve  any particular levels of  revenue in the future.  In 
particular, management's expectations regarding  Jetrea could be affected  by, 
among other  things, unexpected  regulatory actions  or delays  or  government 
regulation generally; unexpected clinical trial results, including  unexpected 
new clinical  data and  unexpected additional  analysis of  existing  clinical 
data; government, industry and general public pricing pressures; the company's
ability to  obtain  or  maintain  patent  or  other  proprietary  intellectual 
property protection; and the impact that  the foregoing factors could have  on 
the values  attributed  to the  Novartis  Group's assets  and  liabilities  as 
recorded in  the  Group's consolidated  balance  sheet, and  other  risks  and 
factors referred to in  Novartis AG's current  Form 20-F on  file with the  US 
Securities and  Exchange Commission.  Should one  or more  of these  risks  or 
uncertainties materialize, or should  underlying assumptions prove  incorrect, 
actual results may vary materially from those anticipated, believed, estimated
or expected. Novartis is providing the information in this press release as of
this date and does not undertake any obligation to update any  forward-looking 
statements contained in  this press release  as a result  of new  information, 
future events  or  otherwise.  Jetrea  is a  trademark  of  ThromboGenics  NV, 
licensed to Alcon.

About Novartis
Novartis provides innovative  healthcare solutions that  address the  evolving 
needs of patients and societies. Headquartered in Basel, Switzerland, Novartis
offers a diversified portfolio to best meet these needs: innovative medicines,
eye  care,  cost-saving  generic  pharmaceuticals,  preventive  vaccines   and 
diagnostic tools, over-the-counter and animal health products. Novartis is the
only global company with leading positions in these areas. In 2012, the  Group 
achieved net  sales  of USD  56.7  billion,  while R&D  throughout  the  Group 
amounted  to  approximately  USD  9.3  billion  (USD  9.1  billion   excluding 
impairment  and  amortization  charges).   Novartis  Group  companies   employ 
approximately 128,000 full-time-equivalent associates and operate in more than
140  countries  around   the  world.  For   more  information,  please   visit

Novartis   is    on    Twitter.   Sign    up    to   follow    @Novartis    at


[1] Stalmans P, Benz MS, Gandorfer A et al. Enzymatic vitreolysis with
    ocriplasmin for vitreomacular traction and macular holes. N Engl J Med
[2] Jetrea^® Summary of Product Characteristics. ThromboGenics NV. Belgium
[3] Schneider EW, Johnson MW. Emerging nonsurgical methods for the treatment
    of vitreomacular adhesion: a review. Clin Ophthalmol. 2011;5:1151-1165
[4] Hikichi T, Yoshida A, Trempe C. Course of vitreomacular traction syndrome.
    Am J Ophthalmol. 1995;119(1):55-61
[5] Carpineto P,Di Antonio L,Aharrh-Gnama A et al. Diagnosing and Treating
    Vitreomacular Adhesion. Retina 2011 69-73
[6] Bottós, Juliana, et al. Vitreomacular Traction Syndrome. Journal of
    Opthalmalic and Vision Research. 2012;7(2):148-161
[7] Alcon internal estimates
[8] Data on file, Summary of Clinical Overview. ThromboGenics Inc, 2012
[9] Dugel P. Retina Today April 2012;50

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