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Press Release: Novartis receives EC Approval for Beovu(R), a next-generation anti-VEGF treatment for wet AMD, a leading cause of blindness worldwide

-- Beovu (brolucizumab) is the only anti-VEGF treatment approved in Europe

for wet AMD that offers the option to start eligible patients on

three-month dosing intervals immediately after the loading phase1

-- For the more than 20 million people worldwide who are living with wet AMD,

frequent injections are a common reason patients drop off existing

treatments2-4

-- Approval is based on two head-to-head clinical trials, HAWK and HARRIER,

in which Beovu achieved robust vision gains that were non-inferior to

aflibercept at year one (primary endpoint)1,5

-- Beovu also demonstrated superior fluid resolution versus aflibercept at

week 16 and year one (secondary endpoints)1,5

The digital press release with multimedia content can be accessed here:

https://novartis.gcs-web.com/Novartis-receives-EC-Approval-for-Beovu-a-next-generation-anti-VEGF-treatment-for-wet-AMD-a-leading-cause-of-blindness-worldwide

Basel, February 17, 2020 -- Novartis today announced the European

Commission (EC) has approved Beovu(R) (brolucizumab) injection for the

treatment of wet age-related macular degeneration (AMD). Beovu is the

first EC-approved anti-VEGF treatment to demonstrate superior resolution

of retinal fluid (IRF/SRF), a key marker of disease activity, versus

aflibercept (secondary endpoints)(1,5). Beovu also offers the ability

to start eligible wet AMD patients on a three-month dosing interval

immediately after the loading phase(1,5). The EC decision is applicable

to all 27 European Union member states as well as the UK, Iceland,

Norway and Liechtenstein.

"Currently, wet AMD patients, who are often older, can face significant

challenges in managing their disease. We believe that Beovu, and its

ability to resolve fluid, brings great therapeutic value that will help

physicians optimize treatments for patients based on disease activity,"

said Marie-France Tschudin, President Novartis Pharmaceuticals. "With

the approval of this innovative biologic, Novartis is continuing to

reimagine medicine for people living with wet AMD."

"Drying the retina is one of the main goals in the treatment of wet AMD

with anti-VEGF therapy," said Frank Holz, MD, FEBO, FARVO, Professor and

Chairman, Department of Ophthalmology, University of Bonn, Germany.

"Beovu, with its superior fluid resolution as demonstrated in the HAWK

and HARRIER trials, will provide physicians with a new option to treat

wet AMD."

Wet AMD is a chronic, degenerative eye disease caused by an excess of

VEGF, a protein that promotes the growth of abnormal blood vessels

underneath the macula, the area of the retina responsible for sharp,

central vision(6,7). The disease is a leading cause of severe vision

loss and blindness in people over age 65, affecting more than 20 million

people worldwide(3,4,8). In the EU, an estimated 1.7 million people are

affected by wet AMD(9). Early symptoms of wet AMD include blurry or

wavy vision(7). As the disease progresses, patients lose central vision,

making it difficult to see objects directly in front of them(7).

The EC approval was based on findings from the Phase III HAWK and

HARRIER clinical trials, in which Beovu met the primary endpoint,

demonstrating gains in best corrected visual acuity (BCVA) that were

non-inferior to aflibercept at year one (week 48)(1,5). Vision gains at

year one were maintained at year two(1,5).

In fluid-related secondary endpoints, Beovu outperformed

aflibercept(1,5). Significantly fewer patients had intra-retinal and/or

sub-retinal fluid (IRF/SRF), two fluids which may disrupt the normal

retinal structure and cause damage to the macula (31% for brolucizumab 6

mg vs. 45% for aflibercept in HAWK; 26% vs. 44%, respectively, in

HARRIER at year one)(1,5,10). Additionally, Beovu showed superior

reductions in central subfield thickness, another indicator of retinal

fluid, at week 16 and at year one(1,5). Differences seen at year one

were maintained at year two(1,5). In both trials, 30% fewer patients

had signs of disease activity with Beovu versus aflibercept as early as

week 16(11).

In HAWK and HARRIER, over half of patients were maintained on the

three-month dosing interval (56% in HAWK and 51% in HARRIER) at year

one(1,5). The remaining patients in the study were treated on a

two-month dosing interval(1,5).

"Today's approval is a step forward for patients in Europe who have been

looking for a new treatment option which may help them maintain their

sight -- and their independence -- for longer," said Christina Fasser,

President, Retina International. "This can really help to alleviate a

burden, not only on the patient themselves, but also on those who care

for them."

In October 2019, Novartis received approval from the U.S. Food and Drug

Administration for Beovu for the treatment of wet AMD(12). Beovu

received Swissmedic approval in Switzerland(13) and Australian TGA

approval(14) in January 2020, both for the treatment of wet AMD.

Novartis is committed to bringing Beovu to patients worldwide, and

additional regulatory filings are currently underway in Canada, Japan

and Brazil.

About Beovu (brolucizumab)

Beovu (brolucizumab, also known as RTH258) is the most clinically

advanced humanized single-chain antibody fragment (scFv)(5,15).

Single-chain antibody fragments are highly sought after in drug

development due to their small size, enhanced tissue penetration, rapid

clearance from systemic circulation and drug delivery

characteristics(15-17).

The proprietary innovative structure results in a small molecule (26

kDa) with potent inhibition of, and high affinity to, all VEGF-A

isoforms(16). Beovu is engineered to deliver the highest concentration

of drug, providing more active binding agents than other

anti-VEGFs(5,15). In preclinical studies, Beovu inhibited activation of

VEGF receptors through prevention of the ligand-receptor

interaction(16-18). Increased signaling through the VEGF pathway is

associated with pathologic ocular angiogenesis and retinal edema(19).

Inhibition of the VEGF pathway has been shown to inhibit the growth of

neovascular lesions and suppress endothelial cell proliferation and

vascular permeability(19).

About the HAWK and HARRIER studies

With more than 1,800 patients across nearly 400 centers worldwide, HAWK

(NCT02307682) and HARRIER (NCT02434328) are the first and only global

head-to-head trials in patients with wet AMD that prospectively

demonstrated efficacy at week 48 using an innovative q12w/q8w regimen,

with a majority of patients on q12w immediately following the loading

phase(5). Both studies are 96-week prospective, randomized,

double-masked multi-center studies and part of the Phase III clinical

development of Beovu(5). The studies were designed to compare the

efficacy and safety of intravitreal injections of brolucizumab 6 mg

(HAWK and HARRIER) and 3 mg (HAWK only) versus aflibercept 2 mg in

patients with wet AMD(5).

About wet age-related macular degeneration

Wet AMD is the leading cause of severe vision loss and legal blindness

in people over the age of 65 in North America, Europe, Australia and

Asia, impacting an estimated 20 million people worldwide(3,4,8). Wet

AMD occurs when abnormal blood vessels form underneath the macula, the

area of the retina responsible for sharp, central vision(7,20,21).

These blood vessels are fragile and leak fluid, disrupting the normal

retinal architecture and ultimately causing damage to the

macula(7,20,21).

Early symptoms of wet AMD include distorted vision (or metamorphopsia)

and difficulties seeing objects clearly(22). Prompt diagnosis and

intervention are essential(21). As the disease progresses, cell damage

increases, further reducing vision quality(7). This progression can

lead to a complete loss of central vision, leaving the patient unable to

read, drive or recognize familiar faces and potentially depriving them

of their independence(7,23). Without treatment, vision can rapidly

deteriorate(24).

About Novartis in ophthalmology

At Novartis, our mission is to discover new ways to improve and extend

people's lives. In ophthalmology, we develop and deliver life-changing

medicines and therapies for diseases and conditions from front to back

of the eye, enabled by data and transformative technologies. Our

ophthalmic solutions reach more than 150M people per year, from

premature infants to the elderly.

Disclaimer

This press release contains forward-looking statements within the

meaning of the United States Private Securities Litigation Reform Act of

1995. Forward-looking statements can generally be identified by words

such as "potential," "can," "will," "plan," "may," "could," "would,"

"expect," "anticipate," "seek," "look forward," "believe," "committed,"

"investigational," "pipeline," "launch," or similar terms, or by express

or implied discussions regarding potential marketing approvals, new

indications or labeling for the investigational or approved products

described in this press release, or regarding potential future revenues

from such products. You should not place undue reliance on these

statements. Such forward-looking statements are based on our current

beliefs and expectations 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 the investigational or approved products described in

this press release will be submitted or approved for sale or for any

additional indications or labeling in any market, or at any particular

time. Nor can there be any guarantee that such products will be

commercially successful in the future. In particular, our expectations

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February 17, 2020 06:11 ET (11:11 GMT)