Immunomedics Announces Orphan Drug Designation for IMMU-132 for Pancreatic Cancer Therapy

Immunomedics Announces Orphan Drug Designation for IMMU-132 for Pancreatic
Cancer Therapy

MORRIS PLAINS, N.J., June 9, 2014 (GLOBE NEWSWIRE) -- Immunomedics, Inc.,
(Nasdaq:IMMU) today announced that IMMU-132, the Company's antibody-drug
conjugate (ADC) for solid cancer therapy, has received orphan drug status from
the Office of Orphan Products Development of the U.S. Food and Drug
Administration (FDA) for the treatment of pancreatic cancer.

"This is the second orphan designation from FDA for IMMU-132, which has
demonstrated activity in patients with advanced pancreatic cancer, as well
aspartial responses in 5 other types of solid cancer," commented Cynthia L.
Sullivan, President and Chief Executive Officer.

As recently reported by the Company at the American Association for Cancer
Research Special Conference on Pancreatic Cancer: Innovations in Research and
Treatment, 13 pancreatic cancer patients who had failed 1-5 prior therapies
showed a median time-to-progression of 12.7 weeks (range 4.3-21.4 weeks) after
receiving repeated doses of IMMU-132. This compared favorably with the median
8.0 weeks (range 4-36 weeks) estimated from the patients' last prior therapy.

IMMU-132 has also been designated an orphan drug by FDA for the treatment of
patients with small-cell lung cancer. In an ongoing Phase I/II clinical study,
IMMU-132 has resulted in partial responses in patients with colorectal cancer,
esophageal cancer, triple negative breast cancer, and small-cell and
non-small-cell lung cancers.

Orphan drug status is granted by FDA to a drug or biological product to treat
a rare disease or condition upon request of a sponsor. Orphan drug designation
qualifies the Company for various development incentives, including tax
credits for qualified clinical testing, a waiver from FDA's application User
Fee for marketing application, and a seven-year period of marketing
exclusivity in the United States for IMMU-132, if it is approved by FDA for
the treatment of patients with pancreatic or small-cell lung cancer.

The granting of an orphan designation request does not alter the standard
regulatory requirements and process for obtaining marketing approval. Safety
and effectiveness of a drug must be established through adequate and
well-controlled studies.

About IMMU-132

IMMU-132 is composed of hRS7, a humanized antibody that binds to the
trophoblast cell-surface antigen (TROP-2), also known as the epithelial
glycoprotein-1 antigen (EGP-1). TROP-2 is expressed by many human tumors, such
as cancers of the breast, cervix, colon and rectum, kidney, liver, lung,
ovary, pancreas, and prostate, but with only limited expression in normal
human tissues. The antibody, hRS7, internalizes into cancer cells following
binding to TROP-2, making it a suitable candidate for the delivery of
cytotoxic drugs.

SN-38 is the active metabolite of irinotecan, which is a standard therapy for
patients with metastatic colorectal cancer, but has major gastrointestinal and
hematologic toxicity. By attaching SN-38 to tumor-targeting antibodies,
delivery of SN-38 to the tumor may be increased several-fold while mitigating
systemic toxicity. Preclinical studies have indicated that IMMU-132 delivers
120-times the amount of SN-38 to a human pancreatic tumor xenograft than when
irinotecan is given. In various animal models of human cancers, IMMU-132
significantly improved survival and tumor regression.

About Immunomedics

Immunomedics is a clinical-stage biopharmaceutical company developing
monoclonal antibody-based products for the targeted treatment of cancer,
autoimmune disorders and other serious diseases. Immunomedics' advanced
proprietary technologies allow the Company to create humanized antibodies that
can be used either alone in unlabeled or "naked" form, or conjugated with
radioactive isotopes, chemotherapeutics, cytokines or toxins. Using these
technologies, Immunomedics has built a pipeline of nine clinical-stage product
candidates. Immunomedics has an ongoing collaboration with UCB, S.A. (UCB),
who has worldwide rights in non-cancer indications to Immunomedics' Phase III
product candidate, epratuzumab. UCB expects Phase III data in systemic lupus
erythematosus (SLE) in the first quarter of 2015. Immunomedics is exploring
epratuzumab in oncology in collaboration with outside cancer study groups.
Immunomedics' most advanced wholly owned candidate is ^90Y-clivatuzumab
tetraxetan, which is in an ongoing Phase III registration trial in patients
with pancreatic cancer. Immunomedics' portfolio of wholly owned product
candidates also includes antibody-drug conjugates (ADCs) that are designed to
deliver a specific payload of a chemotherapeutic directly to the tumor while
reducing overall toxicity effects that typically occur when these
chemotherapeutic agents are dosed alone. Immunomedics' most advanced ADCs are
IMMU-132 and IMMU-130, which are in Phase I/II trials for a number of solid
tumors and metastatic colorectal cancer (mCRC), respectively. Immunomedics
also has a number of other product candidates that target solid tumors and
hematologic malignancies, as well as other diseases, in various stages of
clinical and pre-clinical development. These include bispecific antibodies
which have application as T-cell redirecting immunotherapies targeting cancers
and infectious diseases as well as next-generation therapies in cancer and
autoimmune disease. Immunomedics creates these bispecific antibodies using its
patented DOCK-AND-LOCK™ (DNL™) protein conjugation technology. The Company
believes that its portfolio of intellectual property, which includes
approximately 248 active patents in the United States and more than 400
foreign patents, protects its product candidates and
technologies.Immunomedics' strength in intellectual property has resulted in
the top-4 ranking in the January 2014 Patent Board scorecard in the
Biotechnology industry. For additional information on the Company, please
visit its website at The information on its website does
not, however, form a part of this press release.

This release, in addition to historical information, may contain
forward-looking statements made pursuant to the Private Securities Litigation
Reform Act of 1995. Such statements, including statements regarding clinical
trials (including the funding therefor, outcomes, timing or associated costs),
out-licensing arrangements (including the timing and amount of contingent
payments), forecasts of future operating results, potential collaborations,
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, new product development (including clinical trials outcome and regulatory
requirements/actions), our dependence on UCB for the further development of
epratuzumab for non-cancer indications, risks associated with the outcome of
pending litigation, competitive risks to marketed products and availability of
required financing and other sources of funds on acceptable terms, if at all,
as well as the risks discussed in the Company's filings with the Securities
and Exchange Commission.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.

CONTACT: For More Information:
         Dr. Chau Cheng
         Senior Director, Investor Relations & Grant Management
         (973) 605-8200, extension 123
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