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2014-05-23

Novartis International AG: Alcon receives positive CHMP opinion for Simbrinza®, a new fixed-dose combination medicine to treat patients with glaucoma

Novartis International AG / Alcon receives positive CHMP opinion for
Simbrinza®, a new fixed-dosecombination medicine to treat patients with
glaucoma . Processed and transmitted by NASDAQ OMX Corporate Solutions.The
issuer is solely responsible for the content of this announcement.
* Simbrinza®reduced intraocular pressure in two Phase III studies by 23%-34%,
25%-37% respectively, providing strong efficacy, sustained control
throughout the day[1]

* Only beta blocker-free, fixed-dose combination treatment in Europe for
patients contraindicated for beta blockers due to certain respiratory or
cardiac conditions[1],[2]

* If approved, will reduce patients' treatment burden, increase options to
control high intraocular pressure[1], the only known modifiable risk factor
for glaucoma[1]

* Over 60 million people worldwide live with glaucoma - Alcon offers one of
the broadest portfolios to treat all stages of this progressive, eye
disease[3],[4]

Basel, May 23, 2014
- Alcon, the global leader in eye care and division of Novartis, announced
that the Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) has issued a positive opinion for
Simbrinza®eye drops suspension (brinzolamide 10 mg/mL and brimonidine
tartrate 2 mg/mL) to decrease elevated intraocular pressure (IOP) in adult
patients with open-angle glaucoma or ocular hypertension, for whom
monotherapy provides insufficient IOP reduction[1].

Simbrinza®combines two medicines already approved for the treatment of
elevated IOP into one multi-dose bottle, to be dosed with one drop into the
affected eye(s) twice daily. If approved, this fixed-dose combination therapy
will offer a simplified eye drop schedule and reduce the treatment burden for
patients suffering from open-angle glaucoma or ocular hypertension.

"We are pleased by the positive CHMP opinion for Simbrinza®. Glaucoma is a
progressive eye disease that must be treated every day over the course of a
patient's life. By combining two therapies in one, Simbrinza®will help
patients to effectively manage high eye pressure, with a simple dosing
regimen", said Jeff George, Division Head, Alcon. "Alcon is committed to the
research and development of medical and surgical solutions to treat this
cause of irreversible blindness."

The CHMP opinion was based on two pivotal Phase III clinical trials,
evaluating the safety and efficacy of Simbrinza®administered twice daily.
Results showed that IOP reductions from baseline with Simbrinza®were 25%-37%
in glaucoma patients, thus providing strong efficacy with sustained IOP
control throughout the day. Simbrinza®is also the only fixed-dose combination
therapy available to lower IOP that does not contain beta blockers. While
beta blockers are often prescribed to effectively lower IOP, they are
contraindicated in patients with certain respiratory or cardiac
conditions.[5]

"With effective treatments, we can slow down glaucoma progression. Elevated
ocular pressure is the most important risk factor for glaucoma: so keeping
eye pressure under control is the key to helping glaucoma patients preserve
their sight,"[6] said Professor Stefano Gandolfi, MD, Head of Ophthalmologic
Clinic, University of Parma, Italy, and one of the investigators.
"Simbrinza®, if approved, will represent an effective and patient-focused
option for treating a chronic sight-threatening disease, such as glaucoma."

The two, pivotal six-month Phase III studies evaluated the safety and efficacy
of Simbrinza®administered twice daily, and enrolled a total of 1,450 patients
with open-angle glaucoma or ocular hypertension who were insufficiently
controlled on monotherapy or were already using multiple IOP-lowering
medications. The primary endpoint for both studies was an assessment of mean
diurnal IOP change from baseline at three months, with safety and supportive
efficacy evaluated through six months. Both studies met their primary
endpoints.[1]

The first study[1] compared Simbrinza®to brinzolamide 10 mg/mL eye drops
suspension, administered twice daily, to brimonidine tartrate 2 mg/mL eye
drops solution. Simbrinza®showed a statistically superior IOP-lowering effect
compared to either brinzolamide or brimonidine at month 3, showing a 23%-34%
reduction from baseline in IOP. The mean diurnal IOP reduction at month 3 was
greater for patients treated with Simbrinza®(7.9 mmHg) vs. brinzolamide (6.5
mmHg) or brimonidine (6.4 mmHg) treatment groups. The mean baseline diurnal
IOP for the Simbrinza, Brinzolamide, and Brimonidine treatment groups was
25.9, 25.9 and 26.0 mmHg, respectively.

The second study compared Simbrinza®to brinzolamide 10 mg/mL and brimonidine
tartrate 2 mg/mL, dosed concomitantly. The IOP-lowering effect of
Simbrinza®was non-inferior to brinzolamide 10 mg/mL and brimonidine 2 mg/mL,
administered concomitantly. Mean percent IOP reduction from baseline with
Simbrinza®range from 25%-37%. The mean diurnal IOP reduction at month 3 was
similar for patients in the Simbrinza®(8.5 mmHg) and Brinzolamide +
Brimonidine (8.3 mmHg) treatment groups. The mean baseline diurnal IOP for
Simbrinza and the Brinzolamide + Brimonidine treatment groups was 26.4 and
26.5 mmHg, respectively.

In clinical trials, the most frequently reported adverse drug reactions in
patients treated with Simbrinza®were ocular hyperemia and ocular allergic
type reactions.[1] The safety profile of brinzolamide 10 mg/mL and
brimonidine tartrate 2 mg/mL eye drops suspension dosed twice daily
(brinzolamide/brimonidine BD) was similar to that of the individual
components and did not result in additional risk to patients relative to the
known risks of the individual components.

About Glaucoma
Glaucoma is the second cause of irreversible blindness after cataract and
affects more than 60 million people worldwide.[2],[4],[7]Glaucoma is a group
of eye diseases that lead to progressive damage of the optic nerve[8] and can
result in gradual, irreversible loss of vision and eventually
blindness.[9]There is no cure for glaucoma and vision lost cannot be
restored. Medications can lower eye pressure[10], the only known modifiable
risk factor for glaucoma,[3]but must be taken life-long and regularly[8]. The
exact cause of glaucoma is unknown.

Disclaimer
The foregoing release contains forward-looking statements that can be
identified by words such as "positive CHMP opinion," "if approved," "will,"
"could," "positive opinion," "to be," "committed," "offer," or similar terms,
or by express or implied discussions regarding potential marketing approvals
for Simbrinza, or regarding potential future revenues from Simbrinza. 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 Simbrinza will be submitted or approved for
sale in any additional markets, or at any particular time. Nor can there be
any guarantee that Simbrinza will be commercially successful in the future.
In particular, management's expectations regarding Simbrinza could be
affected by, among other things, unexpected regulatory actions or delays or
government regulation generally; the uncertainties inherent in research and
development, including unexpected clinical trial results and additional
analysis of existing clinical data; 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 Form 20-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 Alcon
Alcon, the global leader in eye care, provides innovative products that
enhance quality of life by helping people worldwide see better. The three
Alcon businesses - Surgical, Pharmaceutical and Vision Care - offer the
widest spectrum of eye care products in the world. Alcon is the second
largest division of the Novartis Group with pro-forma sales of USD 10.5
billion in 2013. Headquartered in Fort Worth, Texas, U.S.A., Alcon has more
than 25,000 employees worldwide, operations in 75 countries and products
available in 180 markets. For more information, visitwww.alcon.com.

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, over-the-counter and animal health products. Novartis is the only
global company with leading positions in these areas. In 2013, the Group
achieved net sales of USD 57.9 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 135,000 full-time-equivalent associates and sell products in
more than 150 countries around the world. For more information, please
visithttp://www.novartis.com.

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

References
[1] Alcon data on file, 2013.
[2] European Glaucoma Society (EGS), Terminology and Guidance for Glaucoma,
3rdedition, 2008.

[3] International Agency for the Prevention of
Blindnesshttp://www.iapb.org/vision-2020/what-is-avoidable-blindness/glaucoma

[4] Quigley and Broman, The Number of People with Glaucoma Worldwide in 2010
and 2020.Br J Ophthalmol
2006;90:262-7

[5]Houde M. Prescription of topical antiglaucoma agents for patients with
contraindications to beta-blockers.Can J Ophthalmol.2003 Oct;38(6):469-75.

[6]Lee PP, Association between intraocular pressure variation and glaucoma
progression: data from a United States chart review.Am J Ophthalmol.2007
Dec;144(6):901-907.

[7] Lighthouse International.Prevalence of Vision Impairment
.http://www.lighthouse.org/research/statistics-on-vision-impairment/preva....

[8] National Eye Institute.Facts About Glaucoma, Glaucoma Symptoms.
http://www.nei.nih.gov/health/glaucoma/glaucoma_facts.asp#a

[9] Glaucoma Research Foundation.Understan...

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