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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): September 26, 2006
Immunomedics, Inc.
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(Exact Name of Registrant as Specified in Charter)
Delaware 000-12104 61-1009366
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(State or Other Jurisdiction (Commission (IRS Employer
of Incorporation) File Number) Identification No.)
300 American Road, Morris Plains, New Jersey 07950
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(Address of Principal Executive Offices) (Zip Code)
(973) 605-8200
(Registrant's telephone number, including area code)
Not applicable
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(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions:
[ ] Written communications pursuant to Rule 425 under the Securities
Act (17 CFR 230.425).
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange
Act (17 CFR 240.14a-12).
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2(b)).
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR 240.13e-4(c)).
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ITEM 8.01. OTHER EVENT.
Immunomedics, Inc., a Delaware corporation, reported that licensing
partner, UCB, SA, has temporarily suspended the clinical trials of epratuzumab
in patients with systemic lupus erythematosus. The companies advised their
investigators that this is not being done because of any adverse reactions in
patients, but because of end-stage manufacturing observations by UCB during a
recent audit. These observations, related to the filling processes during final
product manufacturing, in UCB's opinion might result in a lack of consistent
assurance of sterility in the final dosage form. This is a precautionary
measure, taken voluntarily and pro-actively by UCB. No reports of clinical
safety issues that suggest an association with these observations have been
identified. In response to the voluntary suspension, FDA and certain other
regulatory authorities have instituted a clinical hold status on the trials. The
companies are working together to expedite their efforts to remove the clinical
hold status and minimize any delay in making epratuzumab available to patients.
Immunomedics does not believe this suspension will have a material effect on the
trials.
Importantly, Immunomedics has reported to UCB that it has not
encountered any product sterility failures for any batches that have been
released for clinical use nor has it encountered any media fill failures.
Furthermore, to date there have been no clinical safety reports associated with
these observations in the more than 600 patients who have received epratuzumab
therapy. UCB and Immunomedics are diligently addressing the process issues and
UCB will propose a strategy to FDA and other authorities to remove the clinical
hold status and resume dosing patients in the near future. The companies are
particularly concerned that patients who may have already benefited from
epratuzumab in the lupus clinical trials are able to resume treatment as soon as
possible.
UCB has informed Immunomedics they remain fully committed to the
further development of epratuzumab in lupus and potentially other autoimmune
disease indications, while applying the highest quality, safety and ethical
standards in clinical development.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
IMMUNOMEDICS, INC.
By: /s/ Cynthia L. Sullivan
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Name: Cynthia L. Sullivan
Title: President and
Chief Executive Officer
Date: September 26, 2006