Amgen Licenses Late-Stage Lymphoma Therapeutic From Immunomedics.

Business Editors & Health/Medical Writers

THOUSAND OAKS, Calif. & MORRIS PLAINS, N.J.--(BUSINESS WIRE)--Dec. 18, 2000

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.