MORRIS PLAINS, N.J. & THOUSAND OAKS, Calif.--April 8, 2004--Immunomedics, Inc. (Nasdaq:IMMU) and Amgen Inc.
(Nasdaq:AMGN) today announced that Amgen has returned to Immunomedics
all rights for epratuzumab, the humanized CD22 monoclonal antibody
therapeutic licensed to Amgen by Immunomedics in December 2000,
including rights to second generation molecules and conjugates.
As part of the transaction, Immunomedics has agreed to issue to
Amgen a 5-year warrant to purchase 100,000 shares of the Company´s
common stock with a strike price equal to $16.00 per share. Amgen will
receive a final payment of $600,000 from Immunomedics if epratuzumab
is approved for commercialization in the United States for
non-Hodgkin´s lymphoma therapy. There are no other financial
obligations between the parties as a result of the agreement.
Roger M. Perlmutter, M.D., Ph.D., executive vice president of
Research and Development at Amgen, stated, "Our relationship with
Immunomedics has been positive. Phase 2 data demonstrate that
epratuzumab is active against NHL. Epratuzumab was also shown to be
safe and well-tolerated when administered as a single agent or in
combination with rituximab (Rituxan). Our transfer of preclinical and
clinical data to Immunomedics will aid their efforts to develop
epratuzumab, in which endeavors we wish them well."
Immunomedics´ president and chief executive officer, Cynthia L.
Sullivan, commented, "Amgen has been an excellent partner, and we are
pleased with their decision to transfer the epratuzumab program to us.
By regaining North American and Australian rights to our product, we
can now discuss worldwide licensing of this product with other
interested companies. Since epratuzumab is currently being tested in
patients with autoimmune disease, we anticipate that it also may have
utility in this group of indications."
To date, epratuzumab has been studied, either alone or in
combination with rituximab, in over 300 patients with indolent or
aggressive non-Hodgkin´s lymphomas, which are newly diagnosed in more
than 50,000 patients annually in the United States, and where there
are over 350,000 patients being followed with this disease.
Immunomedics is a biopharmaceutical company focused on the
development, manufacture and commercialization of diagnostic imaging
and therapeutic products for the detection and treatment of cancer and
other serious diseases. Integral to these products are highly specific
monoclonal antibodies and antibody fragments designed to deliver
radioisotopes and chemotherapeutic agents to tumors and other sites of
disease. Immunomedics has nine therapeutic product candidates in
clinical development and has two marketed diagnostic imaging products.
The most advanced therapeutic product candidates are LymphoCide(R)
(epratuzumab), for which certain Phase II clinical trials for the
treatment of non-Hodgkin´s lymphoma have already been completed, and
CEA-Cide(R) (labetuzumab), which is in Phase I/II clinical trials for
the treatment of certain solid tumors.
This release, in addition to historical information, contains
forward-looking statements made pursuant to the Private Securities
Litigation Reform Act of 1995. Such statements, including statements
regarding clinical trials, involve significant risks and uncertainties
and actual results could differ materially from those expressed or
implied herein. Factors that could cause such differences include, but
are not limited to, risks associated with new product development
(including clinical trials outcome and regulatory
requirements/actions), competitive risks to marketed products and
availability of financing and other sources of capital, as well as the
risks discussed in the Company´s Annual Report on Form 10-K for the
year June 30, 2003.
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, 2003, 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.
EDITOR´S NOTE: An electronic version of this news release may be
accessed via our Web site at www.amgen.com. Visit the Corporate Center
and click on Amgen News. Journalists and media representatives may
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announcement by filling out a short form in the Amgen News section of
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CONTACT: Amgen, Thousand Oaks
Christine Cassiano, 805-447-4587 (media)
Cary Rosansky, 805-447-1060 (investors)
Immunomedics, Morris Plains
Investor Relations, 973-605-8200
SOURCE: Amgen Inc.