Two Pivotal Phase III Trials In Lupus, Immunomedics

Main Category: Lupus
Article Date: 02 Jun 2005 - 7:00 PDT

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Immunomedics Inc announced patient dosing has begun for the pivotal Phase III clinical trials to further evaluate the safety and efficacy of the Company's lead drug candidate, epratuzumab, for the treatment of patients with systemic lupus erythematosus (SLE), known as lupus.

Epratuzumab has been designated by the U.S. Food and Drug Administration (FDA) as a Fast Track product for the potential treatment of patients with moderate and severe SLE. Epratuzumab is a humanized monoclonal antibody that targets an antigen, known as CD22, found on the surface of a certain class of lymphocytes, a type of white blood cell.

"Epratuzumab has shown activity in patients with SLE with mild depletion of circulating B-lymphocytes. This suggests epratuzumab may work by modulating B-cell function, as contrasted with other B-cell antibodies that appear to require depletion of B-cells. It also implies a possible reduction in the risk of infection, which is commonly associated with lupus, and can be life-threatening. We are pleased to advance our lead drug candidate, epratuzumab, into pivotal Phase III lupus trials, and to be at the forefront of lupus therapy research," commented Ivan D. Horak, M.D., Executive Vice President, Research and Development, and Chief Scientific Officer of Immunomedics.

"There is a need for a new drug that addresses and improves the quality of life for the estimated 3 to 5 million patients worldwide afflicted with lupus, a debilitating and often life-threatening disease. We are pleased that Pharmaceutical Product Development, Inc. (Nasdaq: PPDI) will work with us to execute these pivotal trials," said Cynthia L. Sullivan, President and Chief Executive Officer of the Company. "We continue to hold discussions with potential partners for epratuzumab in all indications, with the aim of securing the best possible agreement for further development of our product and to maximize value for our shareholders."

The pivotal trials are randomized, double-blinded, placebo-controlled, multi-center studies using the BILAG (British Isles Lupus Assessment Group) index to monitor and assess disease activity. A high BILAG score indicates increased disease activity. The trials have been named "ALLEVIATE" or Alleviate Lupus Affliction with Epratuzumab and Validate its Autoimmune Safety and Efficacy. One trial, ALLEVIATE A, is for patients with severe SLE flares, and the second trial, ALLEVIATE B, is for patients with moderately active SLE.

About Epratuzumab

Epratuzumab is Immunomedics' lead product candidate being evaluated in two pivotal Phase III trials for the treatment of moderate and severe SLE. The FDA granted a Fast Track designation to the clinical development program for epratuzumab for the treatment of patients with SLE. Epratuzumab has also demonstrated good safety, tolerability, and clinical efficacy in more than 340 patients with non-Hodgkin's lymphoma, resulting in reports published in The Journal of Clinical Oncology and Clinical Cancer Research.

About Systemic Lupus Erythematosus

Systemic lupus erythematosus (SLE) is a serious autoimmune disease affecting approximately 1.5 million Americans, according to the Lupus Foundation of America. In the U.S., women with SLE outnumber men by a ratio of nine to one, and 80% of female patients develop lupus between the ages of 15 and 45. At present, there is no cure for lupus and no new lupus drug has been approved in the U.S. for nearly 40 years. Lupus most often results in chronic inflammation and pain affecting various parts of the body, especially the skin, joints, blood, and kidneys. The disease can be serious and life threatening. Current treatments used in medical practice include corticosteroids, nonsteroidal anti-inflammatory drugs, immunosuppressives, and antimalarials. The FDA has recently issued a draft guideline to industry on developing drugs for the treatment of SLE that is available at fda.gov/cder/guidance/6496dft.pdf.

About Immunomedics

Immunomedics is a New Jersey-based biopharmaceutical company focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases. We have developed a number of advanced proprietary technologies that allow us to create humanized antibodies that can be used either alone in unlabeled or "naked" form, or conjugated with radioactive isotopes, chemotherapeutics or toxins, in each case to create highly targeted agents. Using these technologies, we have built a pipeline of therapeutic product candidates that utilize several different mechanisms of action. Our lead product candidate, epratuzumab, is currently beginning two pivotal Phase III trials, for the treatment of patients with moderate and severe lupus. We believe that our portfolio of intellectual property, which includes approximately 90 issued patents in the United States, and more than 250 other issued patents worldwide, protects its product candidates and technologies. Visit the Company's web site at http://www.immunomedics.com.

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, out-licensing arrangements, and capital raising activities, 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 fiscal year ended June 30, 2004. The Company is not under any obligation, and the Company expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise

For More Information:
Dr. Chau Cheng
Associate Director, Investor Relations & Business Analysis
(973) 605-8200, extension 123
ccheng@immunomedics.com

Julie Huang
Financial Dynamics
(212) 850-5628
jhuang@fd-us.com

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