Amgen Acquires Filgrastim Franchise Rights From Roche In 100 Markets
THOUSAND OAKS, Calif., Oct. 22, 2013
THOUSAND OAKS, Calif., Oct. 22, 2013 /PRNewswire/ --Amgen (NASDAQ:AMGN) today
announced that it has entered into a definitive agreement with F. Hoffmann-La
Roche ("Roche") to acquire Roche's rights to filgrastim and pegfilgrastim in
approximately 100 markets, effective Jan. 1, 2014.
Roche has held the rights to filgrastim and pegfilgrastim under license from
Kirin-Amgen, Inc. (a joint venture between Amgen and Kirin Holdings Co.
Limited, of Japan) in Eastern Europe, Latin America, Asia, the Middle East and
Africa since 1989. The franchise generated approximately $200 million in sales
in these territories in 2012.
Filgrastim and pegfilgrastim are white blood cell boosting therapeutics used
to reduce the risk of infection in patients receiving chemotherapy. They are
marketed by Amgen in the United States and Europe under the trade names
NEUPOGEN^® and Neulasta^®, respectively.
"This agreement will enable Amgen to reach more patients around the world with
two of our innovative medicines," said Robert A. Bradway, chairman and chief
executive officer of Amgen. "The transaction will also allow us to build
experience and capacity in countries that will be important in accelerating
future growth of Amgen's pipeline products."
Amgen anticipates this deal will be accretive starting in 2014.
Amgen will begin distributing and selling product as soon as practical in
countries where the Company has an existing commercial presence. In countries
where Amgen does not have a presence, Roche or its distributors will continue
to sell and distribute the products for an interim transition period.
"Amgen and Roche will work closely to ensure a seamless transition of the
business, marketing authorizations, and most importantly, product supply to
the physicians and patients that rely on these important medicines," said
Anthony C. Hooper, executive vice president, Global Commercial Operations of
Amgen. "Amgen is pleased to have the opportunity to prevent patients receiving
myelosuppressive chemotherapy from developing febrile neutropenia in
additional markets around the world."
Amgen has grown to be the world's largest independent biotechnology company
reaching millions of patients around the world. A worldwide leader in
biologics manufacturing, Amgen has an outstanding track record of reliably
delivering high-quality medicines to patients who need them.
Kyowa Hakko Kirin Co., Ltd. of Japan will continue to retain product rights
and market filgrastim and pegfilgrastim in some selected Asian territories,
including China and Japan.
About Neulasta and NEUPOGEN
Neulasta (pegfilgrastim) is indicated to decrease the incidence of infection,
as manifested by febrile neutropenia, in patients with nonmyeloid malignancies
receiving myelosuppressive anticancer drugs associated with a clinically
significant incidence of febrile neutropenia. Neulasta is not indicated for
the mobilization of peripheralblood progenitor cells for hematopoietic stem
NEUPOGEN (filgrastim) is indicated to decrease the incidence of infection‚ as
manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies
receiving myelosuppressive anticancer drugs associated with a significant
incidence of severe neutropenia with fever. A complete blood count and
platelet count should be obtained prior to chemotherapy, and twice per week
during NEUPOGEN therapy to avoid leukocytosis and to monitor the neutrophil
Important Safety Information
Do not administer Neulasta to patients with a history of serious allergic
reactions to pegfilgrastim or filgrastim. NEUPOGEN is contraindicated in
patients with known hypersensitivity to E coli-derived proteins, filgrastim‚
or any component of the product.
Serious allergic reactions, including anaphylaxis, can occur in patients
receiving Neulasta or NEUPOGEN. Reported events have occurred with initial
and/or subsequent treatment. Allergic reactions can recur within days after
the discontinuation of initial anti-allergic treatment. Permanently
discontinue Neulasta or NEUPOGEN in patients with serious allergic reactions.
Splenic rupture, including fatal cases, can occur following the administration
of Neulasta and NEUPOGEN. Evaluate for an enlarged spleen or splenic rupture
in patients who report left upper abdominal or shoulder pain after receiving
Neulasta or NEUPOGEN.
Acute respiratory distress syndrome (ARDS) can occur in patients receiving
Neulasta or NEUPOGEN. Evaluate patients who develop fever and lung infiltrates
or respiratory distress after receiving Neulasta or NEUPOGEN for ARDS.
Discontinue Neulasta or NEUPOGEN in patients with ARDS.
Alveolar hemorrhage, manifesting as pulmonary infiltrates and hemoptysis
requiring hospitalization, has been reported in healthy donors undergoing
peripheral blood progenitor cell mobilization, an unapproved use of NEUPOGEN.
Hemoptysis resolved with discontinuation of NEUPOGEN.
Severe sickle cell crises can occur in patients with sickle cell disorders
receiving Neulasta. Severe and sometimes fatal sickle cell crises can occur in
patients with sickle cell disorders receiving filgrastim, the parent compound
Thrombocytopenia has been reported commonly in patients receiving NEUPOGEN.
Platelet counts should be monitored closely.
The granulocyte colony-stimulating factor (G-CSF) receptor, through which
pegfilgrastim and filgrastim act, has been found on tumor cell lines. The
possibility that pegfilgrastim and filgrastim act as growth factors for any
tumor type, including myeloid malignancies and myelodysplasia, diseases for
which they are not approved, cannot be excluded.
Bone pain and pain in extremity occurred at a higher incidence in
Neulasta-treated patients as compared with placebo-treated patients. In
clinical trials involving NEUPOGEN, bone pain was the most frequently reported
Amgen is committed to unlocking the potential of biology for patients
suffering from serious illnesses by discovering, developing, manufacturing and
delivering innovative human therapeutics. This approach begins by using tools
like advanced human genetics to unravel the complexities of disease and
understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics
manufacturing expertise to strive for solutions that improve health outcomes
and dramatically improve people's lives. A biotechnology pioneer since 1980,
Amgen has grown to be the world's largest independent biotechnology company,
has reached millions of patients around the world and is developing a pipeline
of medicines with breakaway potential.
For more information, visit www.amgen.com and follow us on
This news release contains forward-looking statements that involve significant
risks and uncertainties, including those discussed below and others that can
be found in our Form 10-K for the year endedDec. 31, 2012, and in any
subsequent periodic reports on Form 10-Q and Form 8-K.Amgenis providing
this information as of the date of this news release and does not undertake
any obligation to update any forward-looking statements contained in this
document as a result of new information, future events or otherwise.
No forward-looking statement can be guaranteed and actual results may differ
materially from those we project. The Company's results may be affected by
our ability to successfully market both new and existing products domestically
and internationally, clinical and regulatory developments (domestic or
foreign) involving current and future products, sales growth of recently
launched products, competition from other products (domestic or foreign), and
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our products are affected by reimbursement policies imposed by third-party
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CONTACT: Amgen, Thousand Oaks
Christine Regan, 805-447-5476 (media)
Arvind Sood, 805-447-1060 (investors)
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