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2016-02-26

Novartis International AG: FDA approves new indication for Novartis drug Afinitor® for progressive, nonfunctional GI and lung neuroendocrine tumors (NET)

Novartis International AG / FDA approves new indication for Novartis drug
Afinitor® for progressive,nonfunctional GI and lung neuroendocrine tumors
(NET) . Processed and transmitted by NASDAQ OMX Corporate Solutions.The
issuer is solely responsible for the content of this announcement.
* In advanced progressive, nonfunctional NET, Afinitor is the first approved
treatment for patients with lung NET and the first oral therapy for GI NET
* Approval helps fulfill unmet need as progressive, nonfunctional
gastrointestinal and lung NET are rare cancers with poor prognoses, limited
treatment options[1],[2]
* Afinitor is now approved in the US in the three most common types of
advanced NET; regulatory filings for GI/lung indication are underway in
countries worldwide[3]

The digital press release with multimedia content can be accessed here:

Basel, February 26, 2016
-
Novartis today announced that the United States Food and Drug Administration
(FDA) approved Afinitor®(everolimus) tablets for the treatment of adult
patients with progressive, well-differentiated, nonfunctional neuroendocrine
tumors (NET) of gastrointestinal (GI) or lung origin that are unresectable,
locally advanced or metastatic. Afinitor received a priority review
designation providing a shortened review period for drugs that treat serious
conditions and offer a significant improvement in safety or effectiveness.

"Afinitor is the first treatment approved for progressive, nonfunctional NET
of lung origin, and one of very few options available for progressive,
nonfunctional GI NET, representing a shift in the treatment paradigm for
these cancers," said Bruno Strigini, President, Novartis Oncology. "We are
proud of our Afinitor development program, which has translated to meaningful
benefits for patients with several different cancers and rare diseases."

Neuroendocrine tumors are a rare type of cancer that originate in
neuroendocrine cells throughout the body, and are most often found in the GI
tract, lungs or pancreas[1],[4]. NET can be defined as functional or
nonfunctional. Functional NET are characterized by symptoms caused by the
oversecretion of hormones and other substances. Nonfunctional NET may be
characterized by symptoms caused by tumor growth, such as intestinal
obstruction, pain and bleeding for GI NET, and asthma, chronic obstructive
pulmonary disease and pneumonia for lung NET[5],[6],[7],[8]. More than 70% of
patients with NET have nonfunctional tumors[9]. At the time of diagnosis,
5%-44% (depending on site of tumor origin) of patients with NET in the GI
tract and 28% of patients with lung NET have advanced disease, meaning the
cancer has spread to other areas of the body, making it difficult to
treat[1],[4]. Progression, or the continued growth or spread of the tumor, is
typically associated with poor outcomes[10].

The approval of Afinitor was based on efficacy and safety data from a pivotal
study (RADIANT-4) showing Afinitor reduced the risk of progression in
patients with progressive, well-differentiated, nonfunctional NET of GI or
lung origin by 52% (hazard ratio [HR] = 0.48; 95% confidence interval [CI],
0.35-0.67; p<0.001) vs placebo. Additionally, the data showed Afinitor
increased median progression-free survival (PFS) by 7.1 months: median PFS by
central review was 11.0 months (95% CI, 9.2-13.3) in the Afinitor arm and 3.9
months (95% CI, 3.6-7.4) in the placebo arm[3].

In the pivotal trial, the most common treatment-related grade 3/4 adverse
events (AEs) (>=5%) for Afinitor and placebo, respectively, were infections
(11.0% vs 2.0%), diarrhea (9.0% vs 2.0%), stomatitis (9.0% vs 0.0%), fatigue
(5.0% vs 1.0%) and hyperglycemia (5.0% vs 0.0%)[3].

Additional worldwide regulatory filings for this indication are underway, with
a decision in the EU anticipated in 2016.

RADIANT-4 Study: Part of the largest clinical trial program in advanced NET

RADIANT-4 (RAD001InAdvancedNeuroendocrineTumors) is a Phase III prospective,
double-blind, randomized, parallel group, placebo-controlled, multicenter
study. It examined the efficacy and safety of Afinitor plus best supportive
care (BSC) vs placebo plus BSC in 302 patients with unresectable,
progressive, well-differentiated, nonfunctional, locally advanced or
metastatic NET of GI (excluding pancreatic) or lung origin. The major
efficacy outcome measure of RADIANT-4 was PFS based on independent
radiological assessment evaluated by Response Evaluation Criteria in Solid
Tumors. Additional efficacy outcome measures were overall survival and best
overall response rate (defined as complete response plus partial
response)[3].

Patients were randomized 2:1 to receive daily Afinitor 10 mg or daily placebo
orally. All patients received BSC during treatment, which excluded
somatostatin analogues (SSAs). Patients had low or intermediate grade
histology, no history or active symptoms of carcinoid syndrome, had
documented disease progression within the previous 6 months and were required
to have ceased treatment with SSAs for 4 weeks before study entry[3],[11].

The safety profile of Afinitor was consistent with what has been observed in
previous studies of this drug. The most common treatment-related, all-grade
AEs (incidence>=30%) were stomatitis (63%), infections (58%), diarrhea (41%),
peripheral edema (39%), fatigue (37%) and rash (30%). Afinitor was
discontinued for adverse reactions in 29% of patients and dose reduction or
delay was required in 70% of Afinitor-treated patients[3].

About Afinitor®
(everolimus) tablets

Afinitor®(everolimus) tablets is now approved by the United States (US) Food
and Drug Administration (FDA) for the treatment of adult patients with
progressive, well-differentiated, nonfunctional neuroendocrine tumors (NET)
of gastrointestinal (GI) or lung origin that are unresectable, locally
advanced or metastatic. Additionally, Afinitor is approved in 99 countries,
including the US and throughout the European Union, for locally advanced,
metastatic or unresectable progressive NET of pancreatic origin. It is also
approved in>120 countries including the US and European Union for advanced
renal cell carcinoma following progression on or after vascular endothelial
growth factor (VEGF)-targeted therapy (in the US, specifically following
sunitinib and sorafenib).

Afinitor is also approved in 102 countries including the US and European Union
for advanced HR+/HER2- breast cancer in combination with exemestane, after
prior endocrine therapy.

Everolimus is also available from Novartis for use in certain non-oncology
patient populations under the brand names Afinitor®or Votubia®, Certican®and
Zortress®and is exclusively licensed to Abbott and sublicensed to Boston
Scientific for use in drug-eluting stents.

Indications vary by country and not all indications are available in every
country. The safety and efficacy profile of everolimus has not yet been
established outside the approved indications. Because of the uncertainty of
clinical trials, there is no guarantee that everolimus will become
commercially available for additional indications anywhere else in the world.

Important Safety Information about Afinitor®(everolimus) tablets
Afinitor/Votubia can cause serious side effects including lung or breathing
problems, infections (including sepsis), and kidney failure, which can lead
to death. Patients taking concomitant angiotensin-converting enzyme (ACE)
inhibitors may be at an increased risk for angioedema. Mouth ulcers and mouth
sores are common side effects. Afinitor/Votubia can affect blood cell counts,
kidney and liver function, and blood sugar, cholesterol, and triglyceride
levels. Afinitor/Votubia may cause fetal harm in pregnant women. Highly
effective contraception is recommended for women of child-bearing potential
while receiving Afinitor/Votubia and for up to eight weeks after ending
treatment. Women taking Afinitor/Votubia should not breast feed. Fertility in
women and men may be affected by treatment with Afinitor/Votubia.

The most common adverse drug reactions (incidence>=10 percent) are mouth
ulcers, skin rash, feeling tired or weak, diarrhea, infections (including
upper respiratory tract infection, sore throat and runny nose, sinusitis,
middle ear infection and pneumonia), absence of menstrual periods, high
levels of cholesterol, nausea, decreased appetite, low level of red blood
cells, acne, abnormal taste, irregular menstrual periods, inflammation of
lung tissue, swelling of extremities or other parts of the body, high level
of blood sugar, itching, weight loss, nose bleeds, cough and headache. The
most common grade 3-4 adverse drug reactions (incidence>=2 percent) are mouth
ulcers, infections (including pneumonia), low level of red blood cells,
absence of menstrual periods, high level of blood sugar, feeling tired or
weak, diarrhea, low white blood cells, inflammation of lung tissue and
spontaneous bleeding or bruising. Cases of hepatitis B reactivation, blood
clots in the lung or legs, and pneumocystis jirovecii pneumonia (PJP) have
been reported. Abnormalities were observed in hematology and clinical
chemistry laboratory tests.

Disclaimer

The foregoing release contains forward-looking statements that can be
identified by words such as "underway," "anticipated," "yet," "will,"
"committed," "can," "may," or similar terms, or by express or implied
discussions regarding potential new indications or labeling for Afinitor
(everolimus), or regarding potential future revenues from Afinitor. You
should not place undue reliance on these statements. Such forward-looking
statements are based on the current beliefs and expectations of management
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 Afinitor will be submitted or approved for any
additional indications or labeling in any market, or at any particular time.
Nor can there be any guarantee that Afinitor will be commercially successful
in the future. In particular, management's expectations regarding Afinitor
could be affected by, among other things, the uncertainties inherent in
research and development, including unexpected clinical trial results and
additional analysis of existing clinical data; unexpected regulatory actions
or delays or government regulation generally; the company's ability to obtain
or maintain proprietary intellectual property protection; general economic
and industry conditions; global trends toward health care cost containment,
including ongoing pricing pressures; unexpected safety issues; unexpected
manufacturing or quality issues, and other risks and factors referred to in
Novartis AG's current Form 20-F on fi...

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