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Press Release: Novartis: Sandoz announces first patient enrolled in clinical study for proposed biosimilar denosumab in osteoporosis

Novartis International AG / Sandoz announces first patient enrolled in

clinical study for proposed biosimilar denosumab in osteoporosis.

Processed and transmitted by West Corporation. The issuer is solely

responsible for the content of this announcement.

-- Integrated Phase I/lll study for proposed biosimilar denosumab to confirm

matching efficacy, safety and immunogenicity with reference medicine[1]

-- Osteoporosis accounts for 8.9m bone fractures annually, including

debilitating hip fractures -- number set to increase substantially over

next two decades[2]

-- Sandoz has eight marketed biosimilar medicines globally and 10+ molecules

in the pipeline including proposed biosimilar denosumab

Holzkirchen, July 22, 2019 - Sandoz, a Novartis division and a global

leader in biosimilars, today announced the first patient enrolled in

ROSALIA, an integrated Phase I/III clinical study for its proposed

biosimilar denosumab.

The study aims to confirm that the biosimilar matches the reference

medicine in terms of pharmacokinetics, efficacy, safety, and

immunogenicity in patients with postmenopausal osteoporosis[1].

Denosumab is indicated for treating a variety of conditions, such as

osteoporosis in postmenopausal women, increased risk of fractures in men,

treatment-induced bone loss, to prevent bone complications in cancer

that has spread to the bone, and giant cell tumor of the bone[3],[4],[5],

[6]. The study will be conducted in osteoporosis as this is an

adequately sensitive indication and representative of many patients who

are treated with the medicine.

Approximately 200 million people worldwide suffer from osteoporosis,

which results in 8.9 million fractures annually[2],[7]. By 2050, hip

fractures are projected to increase by 240% in women and 310% in men

compared to 1990[2].

"People with the bone disease osteoporosis are more likely to fracture

or break a bone, causing pain and restriction of mobility, which can be

extremely debilitating[8]," said Florian Bieber, Global Head of

Development, Sandoz Biopharmaceuticals. "As we progress our development

program for proposed biosimilar denosumab, we believe it gives patients

hope for early and expanded access to advanced biologic medicines, which

may change the course of their disease."

In ROSALIA, approximately 520 postmenopausal patients with osteoporosis

will be randomized to receive either biosimilar denosumab or the

reference medicine for 52 weeks. Following this period, patients

receiving the reference medicine will be re-randomized to either

continue with a third dose or transition to biosimilar denosumab, until

78 weeks of treatment. The primary endpoints include percentage change

in lumbar spine bone mineral density[1]. The global clinical program for

biosimilar denosumab was developed in consultation with major regulatory

agencies and the results from this clinical study are expected to

support regulatory submissions.

Sandoz biosimilars are helping patients, particularly in immunology,

oncology and endocrinology, access medicines sustainably and affordably.

The division has a leading global portfolio with eight marketed

biosimilars and a further 10-plus in various stages of development. The

Sandoz biosimilar pipeline is a blend of in-house development and

collaborations, both for co-development and commercialization, targeting

key biologics in oncology, immunology, endocrinology and underserved

complex disease areas.

About denosumab

Denosumab is a monoclonal antibody designed to recognize and attach to

the RANKL protein, an activator of osteoclasts (cells involved in

breaking down bone tissue)[3]. By attaching to and inhibiting RANKL,

denosumab decreases the production and activity of osteoclasts,

resulting in a reduction of bone loss, and subsequently the likelihood

of fractures and other serious bone complications[3].

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 "proposed," "potential," "can," "will," "plan," "expect,"

"anticipate," "look forward," "believe," "committed," "investigational,"

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

discussions regarding potential regulatory submissions, marketing

approvals, launches, new indications or labeling for biosimilar

denosumab and the other biosimilar products described in this press

release, or regarding potential future revenues from biosimilar

denosumab 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 biosimilar denosumab or other Sandoz

biosimilars will be submitted or approved for sale in any market, or at

any particular time. Neither can there be any guarantee that, if

approved, biosimilar denosumab or any other Sandoz biosimilar will be

approved for all indications in the originator product 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

denosumab; global trends toward health care cost containment, including

government, payor and general public pricing and reimbursement pressures

and requirements for increased pricing transparency; 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, a Novartis division, is a global leader in generic

pharmaceuticals and biosimilars and a pioneer in the emerging field of

prescription digital therapeutics. Our purpose is to pioneer access to

healthcare by developing and commercializing novel, affordable

approaches that address unmet medical need. Our broad portfolio of

high-quality medicines, covering all major therapeutic areas and

increasingly focused on value-adding differentiated medicines, accounted

for 2018 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.

References

[1] www.clinicaltrials.gov. Study Investigating PK, PD, Efficacy,

Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients

With Postmenopausal Osteoporosis. NCT03974100. Available from:

https://clinicaltrials.gov/ct2/show/NCT03974100?term=GP2411&rank=1 [Last

accessed: June 2019].

[2] International Osteoporosis Foundation. Facts and Statistics.

Available from: https://www.iofbonehealth.org/facts-statistics [Last

accessed: June 2019].

[3] Amgen Europe B.V. Xgeva(R) (Denosumab): Summary of Product

Characteristics. Available from:

https://www.ema.europa.eu/en/documents/product-information/xgeva-epar-product-information_en.pdf

[Last accessed: June 2019].

[4] Amgen Europe B.V. Prolia(R) (Denosumab): Summary of Product

Characteristics. Available from:

https://www.ema.europa.eu/en/medicines/human/EPAR/prolia [Last accessed:

June 2019].

[5] Amgen Inc. Prolia(R) (Denosumab): Prescribing Information.

Available from:

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125320s186lbl.pdf

[Last accessed: June 2019].

[6] Amgen Inc. Xgeva(R) (Denosumab): Prescribing Information.

Available from:

https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125320s094lbl.pdf

[Last accessed: June 2019].

[7] Sözen T, Özisik L, Basaran NÇ. An overview and

management of osteoporosis. Eur J Rheumatol. 2017;4(1):46-56.

[8] NHS. Osteoporosis. Available from:

https://www.nhs.uk/conditions/osteoporosis/ [Last accessed: July 2019].

# # #

Novartis Global External Communications

Email: media.relations@novartis.com

Antonio Ligi Michelle Bauman

Novartis Global External Communications Sandoz Global Communications

+ 41 61 324 1374 (direct) +1 973 714 8043 (mobile)

Email: antonio.ligi@novartis.com Email: michelle.bauman@sandoz.com

Chris Lewis

Sandoz Global Communications

+49 174 244 9501 (mobile)

Email: chris.lewis@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

(MORE TO FOLLOW) Dow Jones Newswires

July 22, 2019 01:15 ET (05:15 GMT)

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