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 Thomas 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 Cynthia 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.
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Related links:
http://www.Immunomedics.com
Company News On-Call:
http://www.prnewswire.com/comp/113121.html
CONTACT:
Chau Cheng, Associate Director, Investor
Relations & Business Analysis, +1-973-605-8200, ext. 123
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