THOUSAND OAKS, Calif., Nov. 11 -- Amgen Inc.
(Nasdaq: AMGN) today announced its decision not to commence a registration
study in non-Hodgkin´s lymphoma and plans to seek another party for the
development and commercialization of its rights to epratuzumab. These plans
follow a review of the current facts and circumstances regarding the product
candidate, Amgen´s assessment of its portfolio and other available
opportunities. Epratuzumab is currently being developed by Amgen in North
America and by Immunomedics, Inc. in Europe for the treatment of indolent and
aggressive non-Hodgkin´s lymphoma.
Amgen is a global biotechnology company that discovers, develops,
manufactures and markets important human therapeutics based on advances in
cellular and molecular biology.
This news release contains forward-looking statements that involve
significant risks and uncertainties, including those discussed below and
others that can be found in Amgen´s Form 10-K for the year ended December 31,
2002, and in Amgen´s periodic reports on Form 10-Q and Form 8-K. Amgen is
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. Amgen´s results may be affected by
its ability to successfully market both new and existing products domestically
and internationally, sales growth of recently launched products, difficulties
or delays in manufacturing its products, and regulatory developments (domestic
or foreign) involving current and future products and manufacturing
facilities. In addition, sales of Amgen´s products are affected by
reimbursement policies imposed by third party payors, including governments,
private insurance plans and managed care providers, and may be affected by
domestic and international trends toward managed care and healthcare cost
containment as well as possible U.S. legislation affecting pharmaceutical
pricing and reimbursement. Government regulations and reimbursement policies
may affect the development, usage and pricing of Amgen´s products.
Furthermore, Amgen´s research, testing, pricing, marketing and other
operations are subject to extensive regulation by domestic and foreign
government regulatory authorities. Amgen or others could identify side
effects or manufacturing problems with its products after they are on the
In addition, Amgen competes with other companies with respect to some of
its marketed products as well as for the discovery and development of new
products. Discovery or identification of new product candidates cannot be
guaranteed and movement from concept to product is uncertain; consequently,
there can be no guarantee that any particular product candidate will be
successful and become a commercial product.
In addition, while Amgen routinely obtain patents for its products and
technology, the protection offered by its patents and patent applications may
be challenged, invalidated or circumvented by its competitors. Further, some
raw materials, medical devices and component parts for Amgen´s products are
supplied by sole third party suppliers.
CONTACT: Amgen, Thousand Oaks
Trish Hawkins, 805/447- 4587 (media)
Cary Rosansky, 805/447-1060 (investors)
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