Press Release: Novartis: Sandoz announces global resolution of biosimilar adalimumab patent disputes, securing patient access

Novartis International AG / Sandoz announces global resolution of

biosimilar adalimumab patent disputes, securing patient access.

Processed and transmitted by West Corporation. The issuer is solely

responsible for the content of this announcement.

-- Global resolution secures patient access to Sandoz biosimilar Hyrimoz(R)

(adalimumab)[1] for the reference medicine Humira(R)**

-- Resolution paves way for 2018 launch in key European markets and secures

US market entry planned in 2023

Holzkirchen, October 11, 2018 - Sandoz, a Novartis division and the

global leader in biosimilars, today announced a global resolution of all

intellectual property (IP) related litigation with AbbVie concerning the

proposed Sandoz biosimilar Hyrimoz(R) (adalimumab)[1] for reference

medicine Humira(R) (**) (adalimumab).

"In order to realize the promise of early and expanded access and

healthcare savings, biosimilars must be available as soon as possible to

the patients and physicians who need them. This settlement helps remove

uncertainty regarding when our biosimilar adalimumab will be available

and allows us to focus on expanding access for patients to the medicine

they need to manage their chronic disease," said Stefan Hendriks, Global

Head of Biopharmaceuticals, Sandoz.

Under the terms of the agreement, AbbVie grants Sandoz a non-exclusive

license to AbbVie's intellectual property relating to Humira(R),

beginning on certain dates in certain countries in which AbbVie has

intellectual property. The license period will begin on October 16, 2018

in most countries in the European Union, and on other dates in various

other countries outside the US where AbbVie has IP. In the US, the

license period will begin on September 30, 2023.

Sandoz will pay royalties to AbbVie for licensing its Humira(R) patents.

All litigation pending between the parties will be dismissed. AbbVie

will make no payments to Sandoz. The precise terms are confidential

between the parties.

Sandoz biosimilar adalimumab was recently approved by the European

Commission (EC) for the 31 countries of the European Economic area,

which comprises the 28 member countries of the European Union plus

Norway, Iceland and Liechtenstein. It is the seventh approved Sandoz

biosimilar medicine.

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 "secures," "paves way," "potentially," "plan," "expected,"

"proposed," "potential," "can," "will," "look forward," "believe,"

"committed," "investigational," "portfolio," "launch," or similar terms,

or by express or implied discussions regarding potential launches,

marketing approvals, new indications or labelling for Hyrimoz and the

other investigational or approved biosimilar products described in this

press release, or regarding potential future revenues from Hyrimoz and

such other biosimilar 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 Hyrimoz or the other investigational or

approved biosimilar products described in this press release will be

launched in any market, or at any particular time. Neither can there be

any guarantee that Hyrimoz or such other products 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,

if approved, such products will be approved for all indications included

in the reference product's label. Neither can there be any guarantee

that Hyrimoz or such other products will be commercially successful in

the future. In particular, our expectations regarding Hyrimoz and such

other 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 regulation generally; the

particular prescribing preferences of physicians and patients;

competition in general, including potential approval of additional

biosimilar versions of such products; global trends toward health care

cost containment, including government, payor and general public pricing

and reimbursement pressures; litigation outcomes, including intellectual

property disputes or other legal efforts to prevent or limit Sandoz from

selling its products; general political and economic conditions; safety,

quality or manufacturing issues; potential or actual data security and

data privacy breaches, or disruptions of our information technology

systems, 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 Sandoz

Sandoz is a global leader in generic pharmaceuticals and biosimilars. As

a division of the Novartis Group, our purpose is to discover new ways to

improve and extend people's lives. We contribute to society's ability to

support growing healthcare needs by pioneering novel approaches to help

people around the world access high-quality medicine. Our portfolio of

approximately 1000 molecules, covering all major therapeutic areas,

accounted for 2017 sales of USD 10.1 billion. In 2017, our products

reached well over 500 million patients and we aspire to reach one

billion. Sandoz is headquartered in Holzkirchen, in Germany's Greater

Munich area.

Sandoz is on Twitter. Sign up to follow @Sandoz_global at

http://twitter.com/Sandoz_Global.

Follow our blog at www.sandoz.com/makingaccesshappen.

References:

[1] European Medicines Agency. Hyrimoz. Key Facts. Available at:

https://www.ema.europa.eu/medicines/human/EPAR/hyrimoz. Accessed October

2, 2018.

(**) Humira(R) (adalimumab) is marketed by AbbVie Deutschland GmbH & Co.

KG in Europe and Humira(R) is a registered trademark of AbbVie

Biotechnology, Inc.

# # #

Novartis Media Relations

Central media line: +41 61 324 2200

E-mail: media.relations@novartis.com

Eric Althoff

Novartis Global Media Relations

+41 61 324 7999 (direct)

+41 79 593 4202 (mobile)

eric.althoff@novartis.com

Chris Lewis Michelle Bauman

Sandoz Global Communications Sandoz Global Communications

+49 8924 476 1906 (direct) ++1 609 720 6699 (direct)

+49 174 244 9501 (mobile) ++1 973 714 8043 (mobile)

chris.lewis@sandoz.com michelle.bauman@sandoz.com

Novartis Investor Relations

Central investor relations line: +41 61 324 7944

E-mail: investor.relations@novartis.com

Central North America

Samir Shah +41 61 324 7944 Richard Pulik +1 212 830 2448

Pierre-Michel Bringer +41 61 324 1065 Cory Twining +1 212 830 2417

Thomas Hungerbuehler +41 61 324 8425

Isabella Zinck +41 61 324 7188

Media release (PDF): http://hugin.info/134323/R/2220303/868720.pdf

This announcement is distributed by West Corporation on behalf of West

Corporation 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

--- End of Message ---

Novartis International AG

P.O. Box Basel Switzerland

WKN: 904278;ISIN: CH0012005267;

http://www.novartis.com

(END) Dow Jones Newswires

October 11, 2018 16:35 ET (20:35 GMT)