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2015-09-04

Novartis International AG: Novartis receives EU approval for Farydak®, the first in its class of anticancer agents approved for patients with multiple myeloma

Novartis International AG / Novartis receives EU approval for Farydak®, the
first in its class of anticanceragents approved for patients with multiple
myeloma . Processed and transmitted by NASDAQ OMX Corporate Solutions.The
issuer is solely responsible for the content of this announcement.
* Farydak (panobinostat) combination is approved in the EU for patients with
multiple myeloma who received >= 2 prior regimens including bortezomib and
IMiD[1]
* In clinical trials, Farydak combination increased PFS by 7.8 months in
patients who received >= 2 prior regimens, including bortezomib and an
IMiD[1]
* As the first HDAC inhibitor approved in the EU for multiple myeloma,
Farydak may help reset key cell function in multiple myeloma through
epigenetic activity[2]
* Farydak is approved in the US and Japan for certain patients with
previously treated multiple myeloma; indications vary by country

Basel, September 4, 2015
-
Novartis announced today that the European Commission has approved
Farydak®(panobinostat, previously known as LBH589) capsules, in combination
with bortezomib* and dexamethasone, for the treatment of adult patients with
relapsed and/or refractory multiple myeloma who have received at least two
prior regimens including bortezomib and an immunomodulatory agent (IMiD). The
approval of Farydak marks the first time a histone deacetylase (HDAC)
inhibitor with epigenetic activity is available in the European Union (EU),
providing a new treatment option for patients living with multiple myeloma
whose disease has progressed after standard-of-care therapy[1,2].

"Farydak is a welcome advance for people living with relapsed and/or
refractory multiple myeloma in Europe," said Philippe Moreau, MD, Department
of Hematology, Centre Hospitalier Universitaire de Nantes, France. "Patients
with multiple myeloma often relapse or stop responding to treatments; Farydak
offers a new mechanism of action, which may improve the effectiveness of
response to standard-of-care treatment in patients."

Multiple myeloma is a cancer of the plasma cells, a type of white blood cell
present in the bone marrow, and affects approximately 84,000 people in
Europe[3,4]. Farydak is the first HDAC inhibitor to show efficacy in multiple
myeloma[5]. As an HDAC inhibitor, its epigenetic activity may help restore
cell function in patients with multiple myeloma[2].

The EU approval of Farydak is based on efficacy and safety data in a subgroup
analysis of 147 patients who had received at least two prior regimens,
including bortezomib and an IMiD, during the Phase III, randomized,
double-blind, placebo-controlled, multicenter global registration trial,
called PANORAMA-1 (PANobinostatORAl in MultipleMyelomA), evaluating Farydak
in combination with bortezomib and dexamethasone against bortezomib and
dexamethasone alone in patients with relapsed and/or relapsed and refractory
multiple myeloma. The trial found that the median progression-free survival
(PFS) benefit in this subgroup increased by 7.8 months in Farydak patients
who had received prior treatment with both bortezomib and an IMiD (12.5
months; n=73), as compared to the placebo arm (4.7 months; n=74) (hazard
ratio=0.47 [95% confidence interval (CI): 0.31, 0.72])[1].

The most common non-hematological adverse reactions included diarrhea,
fatigue, nausea and vomiting. Treatment-emergent hematological toxicities
included thrombocytopenia, anemia, neutropenia and lymphopenia. QTc
prolongation of>480 and<500 msec was recorded in 1.3% of patients and change
from baseline of>60 msec was observed in 0.8% of patients. No patients had an
absolute QTc prolongation of>500 msec. Cardiac events (most frequently atrial
fibrillation, tachycardia, palpitation and sinus tachycardia) were reported
in 17.6% of the Farydak-treated patients versus 9.8% of placebo-treated
patients and syncope events were reported in 6.0% versus 2.4%.
Discontinuation due to adverse events (AEs), regardless of causality, was
observed in 36.2% of patients. The most common AEs leading to treatment
discontinuation were diarrhea (4.5%), asthenia and fatigue (2.9% each) and
pneumonia (1.3%). On treatment deaths not due to the study indication
(multiple myeloma) were reported in 6.8% of Farydak-treated patients versus
3.2% of placebo-treated patients[1].

"With the approval of Farydak in the European Union, we hope to address
critically important treatment needs faced by the multiple myeloma
community-disease progression and treatment resistance," said Bruno Strigini,
President, Novartis Oncology. "This milestone, the approval of a first in its
class treatment option for patients in need of new therapies, is the result
of more than 13 years of dedicated research, which has helped us better
understand the development of multiple myeloma."

Farydak in combination with bortezomib and dexamethasone is also approved in
the US, Chile and Japan for certain patients with previously treated multiple
myeloma. The exact indication for Farydak varies by country. In the US,
Farydak is approved in combination with bortezomib and dexamethasone for the
treatment of patients with multiple myeloma who have received at least two
prior regimens, including bortezomib and an IMiD. Continued approval in the
US may be contingent upon verification and description of clinical benefit in
confirmatory trials.

About multiple myeloma

Multiple myeloma impacts approximately 84,000 people in Europe[4]. Multiple
myeloma is a cancer of the plasma cells, a kind of white blood cell present
in bone marrow-the soft, blood-producing tissue that fills the center of most
bones. The cancer is caused by the production and growth of abnormal cells
within the plasma, which multiply and build up in the bone marrow, pushing
out healthy cells and preventing them from functioning normally[3]. Multiple
myeloma is an incurable disease with a high rate of relapse (when the cancer
returns) and resistance (when the therapy stops working)[6]. Standard-of-care
regimens of proteasome inhibitors and IMiDs are often used to treat multiple
myeloma, but most patients will stop responding to these treatments creating
an unmet need for new options with novel mechanisms of action[6,7,8].
Multiple myeloma typically occurs in individuals 60 years of age or older,
with few cases in individuals younger than 40[9].

About the PANORAMA Clinical Trial Program

PANORAMA-1 (PANobinostatORAl in MultipleMyelomA) is a Phase III, randomized,
double-blind, placebo-controlled, multicenter global registration trial to
evaluate panobinostat in combination with bortezomib and dexamethasone
against bortezomib and dexamethasone alone in patients with relapsed or
relapsed and refractory multiple myeloma who failed on at least one prior
treatment. The study of 768 patients took place in 215 clinical trial sites
worldwide making it the largest global registration trial for multiple
myeloma to date. The primary endpoint of the trial was PFS. Data for overall
survival, the key secondary endpoint of the trial, are not yet mature. Other
secondary endpoints include overall response rate, duration of response and
safety[10].

Farydak®Important Safety Information

Farydak can cause serious side effects, including diarrhea and heart problems.

Diarrhea is common with Farydak and can be severe. Patients should tell their
healthcare provider (HCP) right away if they have abdominal (stomach) cramps,
loose stool, diarrhea, or feel like they are becoming dehydrated. HCPs may
prescribe medicines to help prevent or treat these side effects. Taking or
using stool softeners or laxative medicines may worsen diarrhea, patients
should talk to their HCP before taking or using these medicines.

Farydak can cause severe heart problems which can lead to death. Risk of heart
problems may be increased with a condition called "long QT syndrome" or other
heart problems. Patients should call their HCP and get emergency medical help
right away if they have any of the following symptoms of heart problems:
chest pain, faster or slower heart beat, palpitations (feel like heart is
racing), feel lightheaded or faint, dizziness, blue colored lips, shortness
of breath, or swelling in legs.

Farydak can cause severe bleeding which can lead to death. It may take
patients longer than usual to stop bleeding while taking Farydak. Patients
should tell their HCP right away if they get any of the following signs of
bleeding: blood in stools or black stools (look like tar), pink or brown
urine, unexpected bleeding or bleeding that is severe or that cannot be
controlled, vomit blood or vomit looks like coffee grounds, cough up blood or
blood clots, increased bruising, feeling dizzy or weak, confusion, change in
speech, or headache that lasts a long time.

Farydak is a prescription medicine used, in combination with bortezomib and
dexamethasone, to treat people with a type of cancer called multiple myeloma
after at least two other types of treatment have been tried. It is not known
if Farydak is safe and effective in children.

Patients should tell their HCP about all of the medicines they take, including
prescription and over-the-counter medicines, vitamins and herbal supplements.

Patients should take Farydak exactly as the HCP tells them to take it. The HCP
will tell patients how much Farydak to take and when to take it. The HCP may
change the dose or stop treatment temporarily if patients experience side
effects. Patients should not change the dose or stop taking Farydak without
first talking with their HCP.

Patients should avoid eating star fruit, pomegranate or pomegranate juice, and
grapefruit or grapefruit juice while taking Farydak. These foods may affect
the amount of Farydak in the blood.

Low blood cell counts are common with Farydak and can be severe. Low platelet
count (thrombocytopenia) can cause unusual bleeding or bruising under the
skin. Low white blood cell count (neutropenia) can cause infections. Low red
blood cell count (anemia) may make a patient feel weak, tired, or they may
get tired easily, look pale, or feel short of breath.

There is an increased risk of infection while taking Farydak. Patients should
contact their HCP right away if they have a fever or have any signs of an
infection including sweats or chills, cough, flu-like symptoms, shortness of
breath, blood in phlegm, sores on body, warm or painful areas on body, or
feeling very tired.

Patients should call their HCP right away with any of the following symptoms
of liver problems: feel tired or weak, loss of appetite, dark amber colored
urine, upper abdominal pain, yellowing of skin or the white of eyes.

The most common side effects of Farydak include tiredness, nausea, swelling in
arms or legs, decreased appetite, fever and vomiting. Patients should tell
their HCP if they have any side effect that is bothersome or that does not go
away.
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