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Novartis International AG: Alcon receives FDA approval of Pazeo(TM) Solution for ocular allergy itch relief
  2015-02-02T06:15:34Z   Email  Print
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Novartis International AG / Alcon receives FDA approval of Pazeo(TM) Solution
for ocular allergy itch relief . Processed and transmitted by NASDAQ OMX
Corporate Solutions. The issuer is solely responsible for the content of this
announcement.

  *US Food and Drug Administration grants approval of Pazeo(TM) (olopatadine
    hydrochloride ophthalmic solution) 0.7% for sale in the United States

  *Developed with efficacy data at 24 hours, post dose, to provide one-drop
    daily ocular itch relief associated with allergic conjunctivitis (eye
    allergies)

  *U

to 30% of the U.S. population is affected by seasonal allergy symptoms, with
as many as 70 to 80% of these demonstrating ocular symptoms such as itching[1]

Basel, February 2, 2015 - Alcon, the global leader in eye care and a  division 
of Novartis, has received  approval from the US  Food and Drug  Administration 
(FDA) of Pazeo(TM) (olopatadine  hydrochloride ophthalmic solution) 0.7%,  for 
the treatment of ocular itching associated with allergic conjunctivitis. Pazeo
solution is dosed one drop  daily, and was approved  with efficacy data at  24 
hours, post dose.

"Pazeo solution  represents  an  important  addition  to  our  ocular  allergy 
portfolio in the United  States," said Sabri  Markabi, Senior Vice  President, 
Research &  Development for  Alcon. "Patients  who experience  itching due  to 
allergic conjunctivitis  (eye  allergies), will  now  be  able to  turn  to  a 
one-drop daily product with efficacy data 24 hours after dosing."

As much  as  30%  of the  U.S.  population  is affected  by  seasonal  allergy 
symptoms, and up to  70 to 80%  of these demonstrate  ocular symptoms such  as 
itchy eyes.[1]

Results from two Conjunctival Allergen Challenge clinical studies showed  that 
Pazeo (olopatadine  hydrochloride  ophthalmic  solution)  0.7%,  demonstrated 
statistically significantly improved relief of ocular itching associated  with 
allergic conjunctivitis  at 24  hours post-treatment  compared to  olopatadine 
0.2% (known as Pataday^® solution).* The  safety profile of Pazeo solution  is 
comparable to that of olopatadine 0.2%. In the two clinical studies, the  most 
common adverse reactions occurred in 2  to 5% of patients treated with  either 
Pazeo solution  or a  vehicle.  These events  were  blurred vision,  dry  eye, 
superficial punctate keratitis, dysgeusia and abnormal sensation in the eye.

"Allergic conjunctivitis (eye  allergies) can  be a  24-hour-a-day burden  for 
patients suffering from  those symptoms," said  Eric Donnenfeld, MD,  founding 
partner of Ophthalmic  Consultants of  Long Island and  clinical professor  of 
ophthalmology at New York University.  "Patients now have an available  option 
that can provide ocular  itch relief with efficacy  demonstrated at 24  hours. 
This approval represents an exciting new option in ocular allergy itch  relief 
therapy."

Pazeo solution is anticipated  to be available by  prescription in the  United 
States in March  2015, followed by  Latin American and  Asian markets  through 
2017.

About Allergic Conjunctivitis
Allergic conjunctivitis  is more  commonly referred  to as  eye allergies  and 
affects the conjunctiva, which is the clear layer of skin overlying the  eyes. 
Eye allergies are not typically harmful to a person's eyes or vision; however,
they can cause discomfort. The most common subtypes of allergic conjunctivitis
are seasonal allergic conjunctivitis, which lasts for a short period of  time, 
and perennial allergic conjunctivitis, a chronic, year-round condition.[2]

Important Safety Information About Pazeo (olopatadine hydrochloride ophthalmic
solution) 0.7%
As with  any eye  drop, care  should  be taken  not to  touch the  eyelids  or 
surrounding areas with the dropper tip of the bottle to prevent  contaminating 
the tip and solution. Keep bottle tightly closed when not in use.

Patients should not wear a contact lens if their eye is red. The  preservative 
in Pazeo  solution, benzalkonium  chloride, may  be absorbed  by soft  contact 
lenses. Patients should  be instructed  to wait  at least  five minutes  after 
instilling Pazeo  solution  before  they  insert  their  contact  lenses.  For 
additional  information  about  Pazeo  solution,  please  refer  to  the  full 
prescribing information.

Disclaimer
The foregoing release contains forward-looking statements that can be
identified by words such as "will," "can," "anticipated," or similar terms, or
by express or implied discussions regarding potential future marketing
approvals for Pazeo, or regarding potential future revenues from Pazeo. You
should not place undue reliance on these statements. Such forward-looking
statements are based on the current beliefs and expectations of management
regarding future events, and are subject to significant known and unknown
risks and uncertainties. Should one or more of these risks or uncertainties
materialize, or should underlying assumptions prove incorrect, actual results
may vary materially from those set forth in the forward-looking statements.
There can be no guarantee that Pazeo will be submitted or approved for sale in
any additional markets, or at any particular time. Nor can there be any
guarantee that Pazeo will be commercially successful in the future. In
particular, management's expectations regarding Pazeo could be affected by,
among other things, the uncertainties inherent in research and development,
including unexpected clinical trial results and additional analysis of
existing clinical data; unexpected regulatory actions or delays or government
regulation generally; the company's ability to obtain or maintain proprietary
intellectual property protection; general economic and industry conditions;
global trends toward health care cost containment, including ongoing pricing
pressures; unexpected manufacturing issues, and other risks and factors
referred to in Novartis AG's current Form20-F on file with the US Securities
and Exchange Commission. 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.

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
over-the-counter products. Novartis is the only global company with leading
positions in these areas. In 2014, the Group achieved net sales of USD 58
billion, while R&D throughout the Group amounted to approximately USD 9.9
billion (USD 9.6 billion excluding impairment and amortization charges).
Novartis Group companies employ approximately 130,000 full-time-equivalent
associates and sell products in more than 180 countries around the world. For
more information, please visit http://www.novartis.com.

Novartis   is    on    Twitter.   Sign    up    to   follow    @Novartis    at 
http://twitter.com/novartis.

*Pataday^®   (olopatadine   hydrochloride   ophthalmic   solution)   0.2%,   a 
prescription product  marketed  by Alcon,  is  used to  treat  ocular  itching 
associated with eye allergies.

References:
[1] American College of Allergy, Asthma & Immunology, Allergy Facts.
http://acaai.org/news/facts-statistics/allergies [Accessed December 10, 2014]
[2] WebMD, Allergies Health Center.
http://www.webmd.com/allergies/guide/eye-allergies-1 [Accessed December 10,
2014]

                                    # # #

Novartis Media Relations

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Media release (PDF)

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This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf
of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for
the content, accuracy and originality of the information contained therein.
Source: Novartis International AG via Globenewswire
HUG#1890563

--- End of Message ---

Novartis International AG
P.O. Box Basel Switzerland

WKN: 904278;ISIN: CH0012005267;
 
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