AMGEN INC. (NASDAQ:AMGN) Files An 8-K Entry into a Material Definitive Agreement
Item1.01. Entry into a Material Definitive Agreement.
On April21, 2017, Amgen Inc. (the Company) entered into a
Collaboration Agreement (the Collaboration Agreement) with
Novartis Pharma AG (Novartis) to which Amgen and Novartis
will collaborate on the commercialization of erenumab in the
United States.Under the terms of the Collaboration Agreement,
Novartis will make milestone payments to Amgen that could
collectively exceed $400 million depending on events. Under the
terms of the Collaboration Agreement, Amgen will book sales of
erenumab in the United States, share global research and
development and U.S. commercial efforts and expenses with
Novartis and pay to Novartis a significant royalty on net sales.
The Company and Novartis are parties to the Exclusive License and
Collaboration Agreement dated as of August28, 2015 (as amended to
date, the License Agreement), under which Amgen leads
global development of, and Novartis holds global co-development
rights and commercial rights outside the United States and Japan
to, erenumab and other investigative molecules in the Companys
migraine portfolio. to the License Agreement, Novartis is funding
a disproportional amount of global RD expenses for the products
and will pay Amgen double-digit royalties on net sales of the
products, including erenumab.
The Collaboration Agreement provides that Novartis will assume
agreed upon remaining global RD expenses up to a cap, after which
the parties will equally share global development costs for
erenumab; in each case, except for Japan-specific development
costs not previously agreed under the License Agreement. Novartis
will also fund an agreed-upon portion of U.S. commercialization
costs for erenumab in 2017 and 2018.Thereafter, the companies
will share U.S. commercialization costs equally.
Under the Collaboration Agreement, for the United States the
Company will manufacture erenumab and the parties will jointly
develop the erenumab commercial strategy.Joint governing bodies
oversee global development under the License Agreement and will
oversee commercialization in the United States under the
Collaboration Agreement.The Collaboration Agreement provides that
in the United States, Amgen will promote erenumab in the primary
care and specialist settings, and Novartis will promote erenumab
in the specialist setting.
The Collaboration Agreement and License Agreement will each
continue for the commercial life of the products unless sooner
terminated in accordance with its terms. Each of the
Collaboration Agreement and License Agreement contains a
convenience termination right for Novartis which, in the case of
erenumab, is exercisable only following the fifth anniversary of
regulatory approval of erenumab in the United States.
In a press release issued on April24, 2017, Amgen announced its
entry into the Collaboration Agreement. A copy of the press
release is attached hereto as Exhibit99.1.
Item9.01. Financial Statements and Exhibits.
(d) Exhibits.
| 99.1 | Press Release dated April24, 2017 |
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About AMGEN INC. (NASDAQ:AMGN)
Amgen Inc. is a biotechnology company. The Company discovers, develops, manufactures and delivers various human therapeutics. It operates in human therapeutics segment. Its marketed products portfolio includes Neulasta (pegfilgrastim); erythropoiesis-stimulating agents (ESAs), such as Aranesp (darbepoetin alfa) and EPOGEN (epoetin alfa); Sensipar/Mimpara (cinacalcet); XGEVA (denosumab); Prolia (denosumab); NEUPOGEN (filgrastim), and other marketed products, such as KYPROLIS (carfilzomib), Vectibix (panitumumab), Nplate (romiplostim), Repatha (evolocumab), BLINCYTO (blinatumomab), IMLYGIC (talimogene laherparepvec) and Corlanor (ivabradine). It focuses on human therapeutics for the treatment of serious illness in the areas of oncology/hematology, cardiovascular disease and neuroscience. Its product candidates in Phase III include Erenumab for episodic migraine, Aranesp for myelodysplastic syndromes, BLINCYTO for acute lymphoblastic leukemia and IMLYGIC for metastatic melanoma. AMGEN INC. (NASDAQ:AMGN) Recent Trading Information
AMGEN INC. (NASDAQ:AMGN) closed its last trading session up +2.73 at 163.14 with 2,906,923 shares trading hands.
