Amgen Licenses Late-Stage Lymphoma Therapeutic From Immunomedics
THOUSAND OAKS, Calif. and MORRIS PLAINS, N.J., Dec. 18 /PRNewswire/ --
Amgen (Nasdaq: AMGN) and Immunomedics, Inc. (Nasdaq: IMMU) today announced
that the companies have signed an agreement to license to Amgen a novel cancer
therapeutic antibody for the treatment of indolent (low grade) and aggressive
non-Hodgkin's lymphoma (NHL) developed by Immunomedics.
The humanized antibody, epratuzumab, is being studied in a pivotal
clinical trial to treat indolent NHL patients who either do not respond, or
who do not have a durable response, to the currently available antibody
therapy, Rituxan(R) (Rituximab, IDEC/Genentech). Epratuzumab will also be
studied in a pivotal trial in patients with aggressive NHL who have previously
received other therapy. Epratuzumab is also in a Phase I/II study in
combination with Rituxan in indolent and aggressive NHL patients who have not
previously been treated with an antibody-based product.
Early-phase clinical studies suggest that epratuzumab may provide greater
ease of administration than Rituxan by having a shorter infusion time.
Epratuzumab binds to a different cell surface protein (CD22) than Rituxan
(CD20).
There are approximately 300,000 Americans with NHL. In addition, each
year more than 50,000 new patients are diagnosed with NHL in the United
States.
"Licensing this antibody represents an important step in building Amgen's
cancer portfolio with the best therapeutic and supportive cancer treatment
drugs, including proteins, antibodies and small molecules. As we advance our
own R&D efforts we constantly look for compelling opportunities to add to our
pipeline," said Kevin Sharer, Amgen's Chief Executive Officer. "Immunomedics
is a pioneer in antibodies and licensing this cancer therapeutic is consistent
with our continuing commitment to improving the lives of cancer patients," he
added.
David M. Goldenberg, Chairman and Chief Executive Officer of Immunomedics,
said: "We are delighted to partner with the leader in biotechnology for the
further clinical development and commercialization of epratuzumab, our most
advanced cancer therapeutic."
The agreement provides Amgen with rights to develop and commercialize
epratuzumab in North America and Australia. Amgen will also be responsible
for commercial manufacturing and will assume sponsorship of the U.S. INDs.
Amgen will also receive rights to second-generation CD22 products. In
addition, the agreement contemplates that the license could be expanded to
include rights to Immunomedics' radiolabeled CD22 antibody products.
The agreement includes an $18 million up-front payment to Immunomedics,
clinical milestone payments potentially totaling $65 million and royalties.
In addition, the agreement provides for one-time sales milestone payments
totaling $50 to $225 million if and when annual net sales reach $500 million
to $1 billion. Additional compensation would be paid to Immunomedics for each
second generation product developed by Amgen.
Epratuzumab will represent Amgen's first cancer therapeutic broadly
targeted to oncologists and will be sold by Amgen's oncology sales force, if
the clinical trials succeed and the product receives regulatory approval.
Consummation of this transaction is subject to compliance with
Hart-Scott-Rodino requirements and other customary conditions. This news
release contains forward-looking statements that involve significant risks and
uncertainties, including those discussed below and more fully described in the
Securities and Exchange Commission reports filed by Amgen, including our most
recent Form 10-Q. Amgen conducts research in the biotechnology/pharmaceutical
field where 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.
Furthermore, Amgen's research, testing, pricing, marketing and other
operations are subject to extensive regulation by domestic and foreign
government regulatory authorities. 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. These
government regulations and reimbursement policies may affect the development,
usage and pricing of Amgen's products.
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.
Because forward-looking statements involve risks and uncertainties, actual
results may differ materially from current results expected by Amgen. Amgen
is providing this information as of the date hereof and does not plan to
update this information and expressly disclaims any duty to update information
contained in this press release.
Amgen is a global biotechnology company that discovers, develops,
manufactures and markets cost-effective human therapeutics based on advances
in cellular and molecular biology.
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 infectious diseases.
Integral to these products are highly specific monoclonal antibodies and
antibody fragments designed to deliver radioisotopes and chemotherapeutic
agents to tumors and sites of infection. Sutro & Co., Inc. acted as exclusive
financial adviser to Immunomedics in this transaction.
This release, in addition to historical information, contains
forward-looking statements relating to Immunomedics made pursuant to the
Private Securities Litigation Reform Act of 1995. Such statements, including
the statements regarding future 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 Immunomedics' Quarterly Report on
Form 10-Q for the quarter ended September 30, 2000.
CONTACT: Amgen
Jeff Richardson, 805/447-3227 (media)
Cary Rosansky, 805/447-4634 (investors)
Immunomedics
Cynthia L. Sullivan, 973/605-8200
SOURCE Immunomedics, Inc. and Amgen
Web Site: immunomedics.com
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