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Europe in 2002 and is indicated to decrease the incidence of infection associated with chemotherapy-induced
febrile neutropenia in cancer patients with non-myeloid malignancies. Administration of Neulasta»in all cycles of
chemotherapy is approved for patients receiving myelosuppressive chemotherapy associated with a clinically
significant risk of febrile neutropenia. NEUPOGEN»was launched in the United States and Europe in 1991.
NEUPOGEN»is indicated for reducing the incidence of infection as manifested by febrile neutropenia for patients
with non-myeloid malignancies undergoing myelosuppressive chemotherapy; reducing the duration of neutropenia
and neutropenia-related consequences for patients with non-myeloid malignancies undergoing myeloablative
chemotherapy followed by bone marrow transplantation; reducing the incidence and duration of neutropenia-
related consequences in symptomatic patients with congenital neutropenia, cyclic neutropenia or idiopathic
neutropenia (collectively, severe chronic neutropenia); mobilizing peripheral blood progenitor cells (“PBPC”)
in cancer patients who have undergone myeloablative chemotherapy for stem cell transplantation; and reducing the
recovery time of neutrophils and the duration of fever following induction or consolidation chemotherapy treatment
in adult patients with acute myeloid leukemia (“AML”).
Worldwide Neulasta»/NEUPOGEN»sales for the years ended December 31, 2010, 2009 and 2008 were
$4.8 billion, $4.6 billion and $4.7 billion, respectively. U.S. Neulasta»/NEUPOGEN»sales for the years ended
December 31, 2010, 2009 and 2008 were $3.6 billion, $3.4 billion and $3.4 billion, respectively. International
Neulasta»/NEUPOGEN»sales for the years ended December 31, 2010, 2009 and 2008 were $1.2 billion,
$1.2 billion and $1.3 billion, respectively.
Our outstanding material patents for pegfilgrastim are described in the following table.
Territory General Subject Matter Expiration
U.S. Pegylated G-CSF 10/20/2015
Europe(1) Pegylated G-CSF 2/8/2015
(1) In some cases, this European patent may also be entitled to supplemental protection in one or more countries in
Europe and the length of any such extension will vary by country.
Our outstanding material patents for Filgrastim are described in the following table.
Territory General Subject Matter Expiration
U.S. G-CSF polypeptides 12/3/2013
U.S. Methods of treatment using G-CSF polypeptides 12/10/2013
Our principal European patent relating to G-CSF expired in August 2006. Upon expiration of that patent, some
companies received approval to market products, including biosimilars, that compete with NEUPOGEN»and
Neulasta»in Europe, as further discussed below.
Neulasta»and/or NEUPOGEN»also face competition in some circumstances from companies marketing or
developing treatments for neutropenia associated with chemotherapy, for bone marrow and PBPC transplant
patients, severe chronic neutropenia and AML. Further, NEUPOGEN»competes with Neulasta»in the United
States and Europe, and NEUPOGEN»sales have been adversely impacted by conversion to Neulasta». However,
we believe the conversion in the United States is substantially complete and that a significant amount of the
conversion in Europe has already occurred.
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