01.05.2018 22:26:49

Press Release: Kymriah(R) (tisagenlecleucel), -2-

for global clinical trials.

Novartis Leadership in Immuno-Oncology

Novartis is at the forefront of investigational immunocellular therapy

as the first pharmaceutical company to initiate global CAR-T trials, and

has significantly invested in CAR-T research and worked with pioneers in

the field. Kymriah, the first approved CAR-T cell therapy, is the

cornerstone of this strategy. Active research programs are underway

targeting other hematologic malignancies and solid tumors, and include

efforts focused on next generation CAR-Ts that involve simplified

manufacturing schemes and gene edited cells.

Kymriah(R) (tisagenlecleucel) US Important Safety information

Kymriah may cause side effects that are severe or life-threatening, such

as Cytokine Release Syndrome (CRS) or Neurological Toxicities. Patients

with CRS may experience symptoms including difficulty breathing, fever

(100.4degF/38degC or higher), chills/shaking chills, severe nausea,

vomiting and diarrhea, severe muscle or joint pain, very low blood

pressure, or dizziness/lightheadedness. Patients may be admitted to the

hospital for CRS and treated with other medications.

Patients with neurological toxicities may experience symptoms such as

altered or decreased consciousness, headaches, delirium, confusion,

agitation, anxiety, seizures, difficulty speaking and understanding, or

loss of balance. Patients should be advised to call their healthcare

provider or get emergency help right away if they experience any of

these signs and symptoms of CRS or neurological toxicities.

Because of the risk of CRS and neurological toxicities, Kymriah is only

available through a restricted program under a Risk Evaluation and

Mitigation Strategy (REMS) called Kymriah REMS.

Serious allergic reactions, including anaphylaxis, may occur after

Kymriah infusion.

Kymriah can increase the risk of life-threatening infections that may

lead to death. Patients should be advised to tell their healthcare

provider right away if they develop fever, chills, or any signs or

symptoms of an infection.

Patients may experience prolonged low blood cell counts (cytopenia),

where one or more types of blood cells (red blood cells, white blood

cells, or platelets) are decreased. The patient's healthcare provider

will do blood tests to check all of their blood cell counts after

treatment with Kymriah. Patients should be advised to tell their

healthcare provider right away if they get a fever, are feeling tired,

or have bruising or bleeding.

Patients may experience hypogammaglobulinemia, a condition in which the

level of immunoglobulins (antibodies) in the blood is low and the risk

of infection is increased. It is expected that patients may develop

hypogammaglobulinemia with Kymriah, and may need to receive

immunoglobulin replacement for an indefinite amount of time following

treatment with Kymriah. Patients should tell their healthcare provider

about their treatment with Kymriah before receiving a live virus

vaccine.

After treatment with Kymriah, patients will be monitored lifelong by

their healthcare provider, as they may develop secondary cancers or

recurrence of their cancer.

Patients should not drive, operate heavy machinery, or do other

dangerous activities for eight weeks after receiving Kymriah because the

treatment can cause temporary memory and coordination problems,

including sleepiness, confusion, weakness, dizziness, and seizures.

Some of the most common side effects of Kymriah are difficulty breathing,

fever (100.4degF/38degC or higher), chills/shaking chills, confusion,

severe nausea, vomiting and diarrhea, severe muscle or joint pain, very

low blood pressure, dizziness/lightheadedness, and headache. However,

these are not all of the possible side effects of Kymriah. Patients

should talk to their healthcare provider for medical advice about side

effects.

Prior to a female patient starting treatment with Kymriah, their

healthcare provider may do a pregnancy test. There is no information

available for Kymriah use in pregnant or breast-feeding women. Therefore,

Kymriah is not recommended for women who are pregnant or breast feeding.

Patients should talk to their healthcare provider about birth control

and pregnancy.

Patients should tell their healthcare provider about all the medicines

they take, including prescription and over-the-counter medicines,

vitamins, and herbal supplements.

After receiving Kymriah, patients should be advised that some commercial

HIV tests may cause a false-positive test result. Patients should also

be advised not to donate blood, organs, or tissues and cells for

transplantation after receiving Kymriah.

Please see the full Prescribing Information for Kymriah, including Boxed

WARNING, and Medication Guide at www.Kymriah.com

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,"

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

regarding potential marketing approvals, new indications or labeling for

Kymriah or the other investigational products described in this press

release, regarding our ability to scale and sustain commercial

manufacturing for Kymriah or such other products, or regarding potential

future revenues from Kymriah and such other 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 Kymriah or the other

investigational 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 Novartis will successfully scale and sustain

commercial manufacturing for Kymriah or the other products described in

this press release, or successfully sustain a network of treatment

centers to offer Kymriah. Nor can there be any guarantee that Novartis

will successfully establish and implement indication-based pricing for

Kymriah or the other investigational products described in this press

release, or that such indication-based pricing will achieve the intended

goals of such pricing. Neither can there be any guarantee that Kymriah

and such other products will be commercially successful in the future.

In particular, our expectations regarding Kymriah and such other

products could be affected by, among other things, our ability to

successfully scale and sustain commercial manufacturing and sustain a

network of treatment centers; our ability to successfully establish and

implement indication-based pricing; 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; global trends toward health

care cost containment, including government, payor and general public

pricing and reimbursement pressures; 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 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 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 124,000

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

approximately 155 countries around the world. For more information,

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

Novartis is on Twitter. Sign up to follow @Novartis at

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References

[1] Kymriah (tisagenlecleucel) Prescribing information. East Hanover,

New Jersey, USA: Novartis Pharmaceuticals Corporation; April 2018.

[2] Vacirca JL et al., Ann Hematol. 2014;93(3):403-409.

[3] American Society of Clinical Oncology. Lymphoma - Non-Hodgkin:

Subtypes (Dec. 2016 revision).

http://www.cancer.net/cancer-types/lymphoma-non-hodgkin/subtypes.

Accessed April 2018.

[4] Raut, L., Chakrabarti, P. "Management of relapsed-refractory

diffuse large B cell lymphoma." South Asian J Can, 2014 Jan-Mar; 3(1):

66-7. Accessed April 2018.

[5] Crump M et al., "Outcomes in refractory diffuse large B-cell

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