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2015-09-03

Novartis International AG: Sandoz launches ZarxioTM (filgrastim-sndz), the first biosimilar in the United States

Novartis International AG / Sandoz launches ZarxioTM (filgrastim-sndz), the
first biosimilar in the UnitedStates . Processed and transmitted by NASDAQ
OMX Corporate Solutions.The issuer is solely responsible for the content of
this announcement.
* Launch follows March 6, 2015 FDA approval
* Sandoz One SourceTMoffers patient support services

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

Holzkirchen, September 3, 2015
-
Sandoz, a Novartis company, announced today that Zarxio(TM) (filgrastim-sndz)
is now available in the United States. Zarxio is the first biosimilar
approved by the US Food and Drug Administration (FDA) and the first to launch
in the US.

"As the pioneer and global leader in biosimilars, Sandoz has maintained a
commitment to bringing high-quality biosimilar medicines to patients and
healthcare professionals around the world," said Richard Francis, Global
Head, Sandoz. "With the launch of Zarxio, we look forward to increasing
patient, prescriber and payor access to filgrastim in the US by offering a
high-quality, more affordable version of this important oncology medicine."

"While biologics have had a significant impact on how diseases are treated,
their cost and co-pays are difficult for many patients and the healthcare
budget in general. Biosimilars can help to fill an unmet need by providing
expanded options, greater affordability and increased patient access to
life-saving therapies," said Dr. Ralph Boccia, Medical Director of the Center
for Cancer and Blood Disorders, and Chief Medical Officer for the
International Oncology Network (ION).

Sandoz understands the importance of providing comprehensive patient support
services in the oncology setting. With the launch of Zarxio, Sandoz is also
proud to offer Sandoz One SourceTMa patient services center, providing
support that connects the patient to the information and resources they need.

The launch follows the FDA approval of Zarxio on March 6, 2015. The approval,
via the new biosimilars pathway established under the Biologics Price
Competition and Innovation Act, was based on a comprehensive package of
analytical, nonclinical, and clinical data, which confirmed that Zarxio is
highly similar with no clinically meaningful differences to the US-licensed
reference product. The successful Sandoz pivotal head-to-head PIONEER study
was the final piece of data contributing to the totality of evidence used by
FDA to approve Zarxio as biosimilar to the reference product. Importantly,
the data demonstrating high similarity was sufficient to allow extrapolation
of use of Zarxio to five indications of the reference product.

Sandoz has an unwavering commitment to increasing patient access to
high-quality, life-enhancing biosimilars. Sandoz is the global market leader
and currently markets three biosimilars outside the US. Sandoz has a leading
pipeline with several biosimilars across the various stages of development,
including five programs in Phase III clinical trials/filing preparation.

For more information on Zarxio, please visitwww.zarxio.com.

INDICATIONS

* Patients with Cancer Receiving Myelosuppressive Chemotherapy: to decrease
the incidence of infection, as manifested by febrile neutropenia, in
patients with nonmyeloid malignancies receiving myelosuppressive
anti-cancer drugs associated with a significant incidence of severe
neutropenia with fever.
* Patients with Acute Myeloid Leukemia Receiving Induction or Consolidation
Chemotherapy: to reduce the time to neutrophil recovery and the duration of
fever, following induction or consolidation chemotherapy treatment of
patients with acute myeloid leukemia (AML).
* Patients with Cancer Undergoing Bone Marrow Transplantation: to reduce the
duration of neutropenia and neutropenia-related clinical sequelae, e.g.,
febrile neutropenia, in patients with nonmyeloid malignancies undergoing
myeloablative chemotherapy followed by bone marrow transplantation.
* Patients Undergoing Autologous Peripheral Blood Progenitor Cell Collection
and Therapy: for the mobilization of autologous hematopoietic progenitor
cells into the peripheral blood for collection by leukapheresis.
* Patients with Severe Chronic Neutropenia: for chronic administration to
reduce the incidence and duration of sequelae of neutropenia (e.g, fever,
infections, oropharyngeal ulcers) in symptomatic patients with congenital
neutropenia, cyclic neutropenia, or idiopathic neutropenia.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

* ZARXIO is contraindicated in patients with a history of serious allergic
reactions to human granulocyte colony-stimulating factors such as
filgrastim or pegfilgrastim.

WARNINGS AND PRECAUTIONS

* Splenic rupture, including fatal cases, has been reported following the
administration of filgrastim products. Patients who report left upper
abdominal or shoulder pain should be evaluated.
* Acute respiratory distress syndrome (ARDS) has been reported in patients
receiving filgrastim products. Patients who develop fever and lung
infiltrates or respiratory distress should be evaluated. Discontinue ZARXIO
in patients with ARDS.
* Serious allergic reactions, including anaphylaxis, have been reported in
patients receiving filgrastim products. The majority of reported events
occurred upon initial exposure. Provide symptomatic treatment for allergic
reactions. Allergic reactions, including anaphylaxis, in patients receiving
filgrastim products can recur within days after the discontinuation of
initial anti-allergic treatment. Permanently discontinue ZARXIO in patients
with serious allergic reactions.
* Sickle cell crisis, in some cases fatal, has been reported with the use of
filgrastim products in patients with sickle cell trait or sickle cell
disease.
* Glomerulonephritis has occurred in patients receiving filgrastim products.
The diagnoses were based upon azotemia,hematuria (microscopic and
macroscopic), proteinuria, and renal biopsy. Generally, events of
glomerulonephritis resolved after dose reduction or discontinuation of
filgrastim. If glomerulonephritis is suspected, evaluate for cause. If
causality is likely, consider dose-reduction or interruption of ZARXIO.
* Alveolar hemorrhage manifesting as pulmonary infiltrates and hemoptysis
requiring hospitalization have been reported in healthy donors treated with
filgrastim undergoing peripheral blood progenitor cell (PBPC) collection
mobilization. Hemoptysis resolved with discontinuation of filgrastim. The
use of ZARXIO for PBPC mobilization in healthy donors is not an approved
indication.
* Capillary leak syndrome (CLS) has been reported after G-CSF administration,
including filgrastim products, and is characterized by hypotension,
hypoalbuminemia, edema and hemoconcentration. Episodes vary in frequency,
severity and may be life-threatening if treatment is delayed. Patients who
develop symptoms of capillary leak syndrome should be closely monitored and
receive appropriate treatment.
* Confirm the diagnosis of severe chronic neutropenia (SCN) before initiating
ZARXIO therapy. Myelodysplastic syndrome (MDS) and acute myelogenous
leukemia (AML) have been reported to occur in the natural history of
congenital neutropenia without cytokine therapy. Cytogenetic abnormalities,
transformation to MDS, and AML have also been observed in patients treated
with filgrastim for SCN. Abnormal cytogenetics and MDS have been associated
with the eventual development of myeloid leukemia. The effect of filgrastim
products on the development of abnormal cytogenetics and the effect of
continued filgrastim administration in patients with abnormal cytogenetics
or MDS are unknown. If a patient with SCN develops abnormal cytogenetics or
myelodysplasia, the risks and benefits of continuing ZARXIO should be
carefully considered.
* Thrombocytopenia has been reported in patients receiving filgrastim
products. Monitor platelet counts.
* Leukocytosis: * Patients with Cancer Receiving Myelosuppressive
Chemotherapy:White blood cell counts of 100,000/mm3or greater were observed
in approximately 2% of patients receiving filgrastim at dosages above 5
mcg/kg/day. In patients with cancer receiving ZARXIO as an adjunct to
myelosuppressive chemotherapy, to avoid the potential risks of excessive
leukocytosis, it is recommended that ZARXIO therapy be discontinued if the
ANC surpasses 10,000/mm3after the chemotherapy-induced ANC nadir has
occurred. Monitor CBCs at least twice weekly during therapy. * Peripheral
Blood Progenitor Cell (PBPC) Collection and Therapy:During the period of
administration of ZARXIO for PBPC mobilization in patients with cancer,
discontinue ZARXIO if the leukocyte count rises to>100,000/mm3.
* Cutaneous vasculitis has been reported in patients treated with filgrastim
products. In most cases, the severity of cutaneous vasculitis was moderate
or severe. Most of the reports involved patients with SCN receiving
long-term filgrastim therapy. Hold ZARXIO therapy in patients with
cutaneous vasculitis. ZARXIO may be started at a reduced dose when the
symptoms resolve and the ANC has decreased.
* The possibility that filgrastim acts as a growth factor for any tumor type,
including myeloid malignancies and myelodysplasia, diseases for which
filgrastim is not approved, cannot be excluded. The safety of filgrastim
products in chronic myeloid leukemia (CML) and myelodysplasia has not been
established. When ZARXIO is used to mobilize PBPC, tumor cells may be
released from the marrow and subsequently collected in the leukapheresis
product. Available data is limited and inconclusive.
* The safety and efficacy of filgrastim products given simultaneously with
cytotoxic chemotherapy have not been established. Do not use ZARXIO in the
period 24 hours before through 24 hours after the administration of
cytotoxic chemotherapy. The safety and efficacy of filgrastim products have
not been evaluated in patients receiving concurrent radiation therapy.
Avoid the simultaneous use of ZARXIO with chemotherapy and radiation
therapy.
* Increased hematopoietic activity of the bone marrow in response to growth
factor therapy has been associated with transient positive bone-imaging
changes on nuclear imaging.

ADVERSE REACTIONS

Most common adverse reactions in patients:

* With nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs
(>= 5% difference in incidence compared to placebo) are thrombocytopenia,
nausea, pyrexia, chest pain, pain, fatigue, back pain, arthralgia, bone
pain, pain in extremity, dizziness, cough, dyspnea, rash, blood lactate
dehydrogenase increased and b...

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