Immunomedics' Epratuzumab On FDA Fast Track for Lupus Therapy

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Immunomedics' Epratuzumab On FDA Fast Track for Lupus Therapy

MORRIS PLAINS, N.J., Jan. 5 /PRNewswire-FirstCall/ -- Immunomedics, Inc.

(Nasdaq: IMMU) announced today that it has received notice from the U.S.

Food

and Drug Administration (FDA) granting epratuzumab Fast Track Product

designation for the treatment of patients with moderate to severe systemic

lupus erythematosus (SLE).

" We are pleased to receive the Fast Track designation. The fast track

programs of the FDA are designed to facilitate drug development and to

expedite the review of new drugs that are intended to treat serious or life

threatening conditions, and that demonstrate the potential to address unmet

medical needs, " explained Eckhardt, Sc.D., Vice President, Regulatory

Affairs, Quality Assurance and Quality Control. " As such, the fast track

designation allows for close and frequent interaction with the agency. A

designated fast track drug may also be considered for priority review with a

shortened review time, rolling submission, and accelerated approval if

applicable, " Dr. Eckhardt added.

" This is a significant milestone in the evolution of epratuzumab as a

versatile humanized monoclonal antibody targeting B-cell-mediated autoimmune

diseases and non-Hodgkin's Lymphoma. We believe our antibody may provide a

new treatment option for patients with lupus, a serious life-threatening

disease afflicting 1.5 million Americans, predominantly young women in the

prime of their lives, " remarked L. Sullivan, President and Chief

Executive Officer. " Clinical plans include the initiation of Phase III

trials

in the first half of 2005, which will be conducted by an already identified

Clinical Research Organization, " continued Ms. Sullivan.

" We believe that epratuzumab has therapeutic potential in lowering

disease

activities in various organs, as demonstrated by our recent phase II studies

in Europe, " commented Ivan D. Horak, M.D., Executive Vice President,

Research

and Development, and Chief Scientific Officer. " Epratuzumab seems to show

activity in SLE patients without a drastic drop in their circulating B-

lymphocytes, thus perhaps reducing their risk of infection. This suggests

to

us that this CD22-targeting molecule may work by modulating B-cell function,

as contrasted by other B-cell antibodies that appear to require depletion of

B-cells, " Dr. Horak further explained.

The Company submitted an application with the FDA for Fast Track

designation based on positive results from a Phase II study presented at the

68th annual scientific meeting of American College of Rheumatology

(ACR)/Association of Rheumatology Health Professionals (ARHP) (please refer

to

http://www.immunomedics.com/news_pdf/2004_PDF/PR10192004.pdf).

Immunomedics is a 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. 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 our product candidates and

technologies.

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 year 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.

Company Contact: Chau Cheng, Associate Director, Investor Relations &

Business Analysis, (973) 605-8200, extension 123. Visit the Company's web

site

at http://www.immunomedics.com.

SOURCE Immunomedics, Inc.

Web Site: http://www.Immunomedics.com