Press Release: Novartis new Cosentyx(R) data confirms robust efficacy and quality of life improvements in scalp psoriasis

Novartis International AG / Novartis new Cosentyx(R) data confirms

robust efficacy and quality of life improvements in scalp psoriasis.

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solely responsible for the content of this announcement.

-- Majority of patients with scalp psoriasis on Cosentyx(R) (secukinumab)

achieved clear skin (PSSI 90) at Weeks 12 and 24 and improved quality of

life[1]

-- Scalp psoriasis affects 60 million people worldwide - a

difficult-to-treat form of psoriasis with a substantial impact on quality

of life[1]-[5]

-- Cosentyx data presented at AAD adds to robust evidence demonstrating

sustained efficacy in plaque, nail, palmoplantar and scalp psoriasis as

well as psoriatic arthritis[6]-[12]

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

https://novartis.gcs-web.com/news-releases/news-release-details/novartis-new-cosentyxr-data-confirms-robust-efficacy-and-quality

Basel, February 16, 2018 - Novartis has presented new Cosentyx(R)

(secukinumab) data from the prospective Phase III SCALP study which

showed significant improvement in skin clearance with Cosentyx in

patients with scalp psoriasis. Due to the presence of hair, scalp

psoriasis is particularly difficult to treat with common topical and

phototherapy options[13]. These study results were presented at the 2018

American Academy of Dermatology (AAD) Annual Meeting in San Diego,

California.

"Scalp psoriasis can be painful and in some cases, can lead to temporary

hair loss and cause the involved area to crack and bleed," said Kristian

Reich, M.D., Ph.D., Georg-August-University Göttingen and

Dermatologikum Hamburg, Germany. "The data presented at AAD is

encouraging for both physicians and patients, who can have greater trust

in Cosentyx as a complete treatment option for patients with plaque

psoriasis who want to avoid scalp and other manifestations of

psoriasis."

Approximately 60 million people worldwide are impacted by scalp

psoriasis[4],[5], a form of the disease which can have a substantial

impact on quality of life due its highly visible nature. Additional

stress may be added as many psoriasis patients will not achieve an

adequate response from standard treatments[13].

"As a science driven company, we are committed to investigating the full

potential of Cosentyx. It is our ambition to offer the best evidence to

doctors, and to deliver the best treatment to patients," said Eric

Hughes, Global Development Unit Head, Immunology & Dermatology.

"Cosentyx is backed by a large study program including more than 10,000

patients in over 60 studies since our first Cosentyx study initiation 10

years ago. We believe that study data on specific manifestations such as

scalp help doctors reach the right decisions with their patients."

Cosentyx is a fully human interleukin-17A (IL-17A) inhibitor which has

demonstrated rapid and sustained long term efficacy in the treatment of

moderate-to-severe psoriasis, psoriatic arthritis and ankylosing

spondilytis, as well as a consistently favorable safety profile

including injection site pain at rates similar to placebo[6]-[12]. To

date, Cosentyx has been prescribed to more than 140,000 patients

worldwide across all indications since launch[14].

About psoriasis

Psoriasis is a distressing and painful autoimmune disease that affects

more than 125 million people worldwide[4]. It is a debilitating

condition associated with a significant emotional and physical daily

burden. In the long-term, psoriasis can also lead to other conditions,

such as diabetes, heart disease, depression and psoriatic arthritis

(PsA) - which up to 30% of patients with psoriasis may develop[4],[15].

Plaque psoriasis is the most common form of the disease and appears as

raised, red skin patches covered with a silvery white build-up of dead

cells. Most patients with psoriasis will also develop difficult-to-treat

forms of the disease which appear on the scalp, nails, palms of the

hands or soles of the feet and are associated with further pain,

decreased mobility and functional impairment[2],[16]-[18].

About Cosentyx (secukinumab) and IL-17A

Cosentyx is the first and only fully human interleukin-17A (IL-17A)

inhibitor approved to treat psoriasis, PsA and ankylosing spondylitis

(AS)[19]. Cosentyx is a targeted treatment that specifically inhibits

IL-17A, cornerstone cytokine involved in the pathogenesis of psoriasis,

and the inflammation of the entheses in PsA and AS[19]-[22].

Cosentyx delivers psoriasis patients long-lasting skin clearance, with

proven sustainability and safety out to 5 years[8]. Cosentyx has been

studied in dedicated trials for difficult-to-treat types of plaque

psoriasis - palmoplantar psoriasis (psoriasis of the hands and feet),

scalp psoriasis, and nail psoriasis[19].

Cosentyx has a large clinical trials program in psoriasis, PsA and AS

which includes over 60 studies and over 10,000 patients[23]. To date,

Cosentyx has been prescribed to more than 140,000 patients worldwide

since launch[14].

About the SCALP study[1]

This study is a randomized, double-blind, placebo-controlled study to

evaluate the efficacy and safety of Cosentyx in 102 patients with

moderate-to-severe scalp psoriasis. Eligible patients were equally

randomized to either subcutaneous Cosentyx 300 mg or placebo at Weeks 0,

1, 2, 3 and 4, then every four weeks for 12 weeks. At Week 12, patients

in the placebo group who did not achieve at least a 90% improvement from

baseline in the Psoriasis Scalp Severity Index (PSSI) score were

re-randomized to Cosentyx 300 mg until study completion. The primary

endpoint was the proportion of patients who achieved PSSI 90 response

rate at Week 12.

In the SCALP study, PSSI 90 response rates were achieved by a

significantly higher proportion of patients receiving Cosentyx vs.

placebo at Week 12 (52.9% vs. 2.0%), with further improvements in those

taking Cosentyx up to Week 24 (58.8%). The safety profile of Cosentyx

was in line with the known safety profile for Cosentyx.

About Novartis Immunology & Dermatology

Novartis is a global leader in Immunology & Dermatology. We are

dedicated to transforming the lives of people living with immunologic

diseases, focusing on immunodermatology, rheumatology and specialty

liver diseases. Our Immunology & Dermatology pipeline includes multiple

compounds in liver disease and other immunological areas where high

unmet medical needs exist.

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," "expect," "anticipate,"

"look forward," "believe," "committed," "investigational," "pipeline,"

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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

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approved products described in this press release will be submitted or

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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 regarding such products could be affected

by, among other things, the uncertainties inherent in research and

development, including clinical trial results and additional analysis of

existing clinical data; regulatory actions or delays or government

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including government, payor and general public pricing and reimbursement

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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 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, cost-saving generic and biosimilar

pharmaceuticals and eye care. Novartis has leading positions globally in

each of these areas. In 2017, the Group achieved net sales of USD 49.1

billion, while R&D throughout the Group amounted to approximately USD

9.0 billion. Novartis Group companies employ approximately 122,000

full-time-equivalent associates. Novartis products are sold in

approximately 155 countries around the world. For more information,

please visit http://www.novartis.com.

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February 16, 2018 16:05 ET (21:05 GMT)