FREMONT and THOUSAND OAKS, Calif. ??? October 14, 2003 ??? Abgenix
(Nasdaq: ABGX) and Amgen Inc. (Nasdaq: AMGN) today announced that Abgenix
and Amgen´s wholly owned subsidiary, Immunex Corporation, have amended
their agreement for ABX-EGF to clarify clinical development, manufacturing
and commercialization responsibilities. ABX-EGF, a fully human monoclonal
antibody directed against the epidermal growth factor receptor (EGFr), is
in multiple clinical studies for several oncology indications.
Under the amended agreement, Immunex will have decision-making authority
for development and commercialization activities. Under a separate agreement,
Abgenix will manufacture both clinical and early commercial supplies of ABX-EGF
with Immunex´s support and assistance. The companies will continue to
share program costs equally, as well as worldwide operating profits from future
sales of ABX-EGF.
???We believe this amended agreement provides the optimal structure to
advance the ABX-EGF program quickly and efficiently,??? said Dr. Raymond
Withy, CEO and President of Abgenix. ???Our manufacturing capabilities
will be critical to the late stage development and potential launch of this
exciting product candidate.???
Under the amendment, Immunex will make available to Abgenix $60 million in
the form of advances that may be used by Abgenix to fund its share of development
and commercialization costs for ABX-EGF after Abgenix has contributed $20
million toward development costs in 2004. The amount of any advances drawn
by Abgenix, plus interest, may be repaid out of profits resulting from future
product sales. However, Abgenix is not obligated to repay any portion of the
loan if ABX-EGF does not reach commercialization.
ABX-EGF targets the epidermal growth factor receptor (EGFr), which is over-expressed
in a variety of cancers including lung, breast, pancreatic, bladder, prostate,
colorectal, kidney, and head and neck cancers. Research has demonstrated that
cancer cells can become dependent on growth signals mediated through EGFr
for their survival. In preclinical research, ABX-EGF monotherapy has been
shown to inhibit the growth of human tumors in mice.
Co-developed by Abgenix and Immunex, ABX-EGF is being evaluated in a comprehensive
clinical program in several indications. Results of several clinical studies
have demonstrated single-agent activity and a favorable pharmacokinetic and
Abgenix is a biopharmaceutical company focused on the discovery, development
and manufacturing of human therapeutic antibodies. The company´s antibody
development platform includes a leading technology and state-of-the-art manufacturing
capabilities that enable the rapid generation, selection and production of
high affinity, fully human antibody product candidates to a variety of disease
targets. Abgenix leverages its leadership position in human antibody technology
to build a diversified product portfolio through the establishment of collaborations
with multiple pharmaceutical and biotechnology companies. For more information
on Abgenix, visit the company´s website at www.abgenix.com.
Statements made in this press release about Abgenix´s technologies, product
development activities, collaborative arrangements and manufacturing activities,
other than statements of historical fact, and about its projected financial
results, are forward-looking statements and are subject to a number of uncertainties
that could cause actual results to differ materially from the statements made,
including risks associated with the success of clinical trials, the progress
of research and product development programs, product manufacturing, the regulatory
approval process, competitive products, future capital requirements and the
extent and breadth of Abgenix´s patent portfolio. Please see Abgenix´s public
filings with the Securities and Exchange Commission for information about
risks that may affect Abgenix.
Amgen is a global biotechnology company that discovers, develops, manufactures
and markets important human therapeutics based on advances in cellular and
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 market.
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.