Press Release: Novartis: Sandoz decides not to pursue US biosimilar rituximab; will focus on robust biosimilar portfolio for unmet access and sustainability ...

Novartis International AG / Sandoz decides not to pursue US biosimilar

rituximab; will focus on robust biosimilar portfolio for unmet access

and sustainability needs. Processed and transmitted by West

Corporation. The issuer is solely responsible for the content of this

announcement.

-- Decision follows FDA request for additional information to complement

submission for biosimilar rituximab

-- Sandoz stands behind safety, efficacy and quality of our biosimilar

rituximab, which is already approved in EU, Switzerland, Japan and

Australia

-- With seven biosimilars already approved globally, Sandoz will focus on

progressing robust pipeline to enable early and expanded patient access

and healthcare savings

Holzkirchen, Germany, November 2, 2018 - Sandoz, a Novartis division and

the pioneer and global leader in biosimilars, today announced that it

will not pursue its submission for biosimilar rituximab in the US at

this time. The decision follows a request by the US Food and Drug

Administration (FDA) for additional information to complement the

submission. Sandoz will focus on progressing its biosimilar pipeline in

areas of greatest unmet access needs.

"We appreciate the important conversations with the FDA, which have

provided specific requirements for our potential US biosimilar rituximab,

but believe the patient and marketplace needs in the US will be

satisfied before we can generate the data required," said Stefan

Hendriks, Global Head of Biopharmaceuticals, Sandoz.

"We are disappointed to have to make this decision and stand behind the

safety, efficacy and quality of our medicine, which met the stringent

criteria for approval in the European Union, Switzerland, Japan, New

Zealand and Australia. Given the breadth of our biosimilar pipeline, we

believe we should now focus on opportunities in the US and around the

world where we can best meet rapidly evolving patient and healthcare

system needs."

Sandoz remains committed to enabling early and expanded patient access

and creating savings for healthcare systems through a robust biosimilar

portfolio. Sandoz has seven approved biosimilars worldwide, three of

which are approved in the US, and is currently awaiting marketing

authorization in the EU for pegfilgrastim, following a CHMP positive

opinion in September 2018.

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 "focus on," "potential," "can," "will," "plan," "expect," "look

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

"portfolio," "launch," or similar terms, or by express or implied

discussions regarding potential marketing approvals, new indications or

labeling for the investigational or approved biosimilar 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. Neither can there be any guarantee that, if approved, such

biosimilar products will be approved for all indications included in the

reference product's label. 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 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 1,000 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. 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.

# # #

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

+49 174 244 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/2223810/871562.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

November 02, 2018 18:00 ET (22:00 GMT)