Press Release: Novartis: Sandoz Resolves Generic Drug Antitrust Investigation in the U.S.

Princeton, New Jersey, March 2, 2020 -- Sandoz Inc. has reached a

resolution with the U.S. Department of Justice (DOJ) Antitrust Division

concerning the Department's more than three-year-long antitrust

investigation into the U.S. generic drug industry. The Sandoz resolution

relates to instances of misconduct at the company between 2013 and 2015

with regard to certain generic drugs sold in the United States. As part

of the resolution, Sandoz has agreed to pay USD 195 million and will

enter into a deferred prosecution agreement (DPA).

Sandoz is a global leader in generic pharmaceuticals and biosimilars

with a broad portfolio of high-quality medicines covering all major

therapeutic areas. In the U.S., during the period in question, the

company provided patients with over 400 marketed generic medicines.

As recognized by the DOJ, Sandoz cooperated with the government's

investigation. Individuals implicated in the underlying conduct are no

longer employed by the company.

Under the terms of the agreement, Sandoz will continue to take steps to

enhance its compliance program, employee training, and monitoring.

Sandoz will also continue to cooperate with the government's ongoing

investigation into the generic pharmaceutical industry.

Carol Lynch, President of Sandoz Inc., said: "We take seriously our

compliance with antitrust laws, and in reaching today's resolution, we

are not only resolving historical issues but also underscoring our

commitment to continually improving our compliance and training programs

and evolving our controls. We are disappointed that this misconduct

occurred in the face of our clear antitrust compliance policies and

multiple trainings -- and in full contravention of the company's

values."

In addition, the company is also in settlement negotiations with the DOJ

Civil Division to resolve potential related claims and is taking a

provision of USD 185 million for this purpose.

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 "will," "deferred," "portfolio," "continue," "take steps," "to

enhance," "to cooperate," "ongoing," "commitment," "evolving," "purpose,

" "potential," "pioneer," "ambition," or similar terms, or by express

or implied discussions regarding potential marketing approvals, new

indications or labeling for the generic and biosimilar products

described in this press release, or regarding potential future revenues

from such products, or regarding the resolution, the DPA, the ongoing

investigation into the generic pharmaceutical industry, and the

compliance, monitoring and training activities described in this press

release. 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

ongoing and future enhancements to our compliance, monitoring and

training activities will be successful, or achieve any particular

outcome, or in any particular time frame. Neither can there be any

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

regarding the resolution, the DPA, the ongoing and future enhancements

to our compliance, monitoring and training activities, and such

products could be affected by, among other things, the possibility that

our enhanced compliance, monitoring and training activities may not

successfully prevent or detect all future improper activities;

regulatory actions or delays or government action generally; the

uncertainties inherent in research and development, including clinical

trial results and additional analysis of existing clinical data;

competition in general, including potential approval of additional

generic or biosimilar versions of Sandoz products; global trends toward

health care cost containment, including government, payor and general

public pricing and reimbursement pressures and requirements for

increased pricing transparency; our ability to obtain or maintain

proprietary intellectual property protection; the particular prescribing

preferences of physicians and patients; general political and economic

conditions; safety, quality, data integrity, 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, a Novartis division, is a global leader in generic

pharmaceuticals and biosimilars. Our purpose is to pioneer access for

patients by developing and commercializing novel, affordable approaches

that address unmet medical need. Our ambition is to be the world's

leading and most valued generics company. Our broad portfolio of

high-quality medicines, covering all major therapeutic areas, accounted

for 2019 sales of USD 9.9 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 http://twitter.com/Sandoz_Global

# # #

Novartis Media Relations

E-mail: media.relations@novartis.com

Antonio Ligi Chris Lewis Sandoz Global

Novartis Global Communications Communications +49 174 244

+41 79 7233681 (mobile) 9501 (mobile)

antonio.ligi@novartis.com chris.lewis@sandoz.com Leslie

Eric Althoff Pott Sandoz US Communications

Novartis US Communications +1 201 354 0279 (mobile)

+1 646 438 4335 leslie.pott@sandoz.com

eric.althoff@novartis.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 Sloan Simpson +1 862 778 5052

Pierre-Michel Bringer +41 61 324 1065 Cory Twining +1 862 778 3258

Thomas Hungerbuehler +41 61 324 8425

Isabella Zinck +41 61 324 7188

(END) Dow Jones Newswires

March 02, 2020 16:34 ET (21:34 GMT)