Sulesomab - LeukoScan; granulocyte monoclonal anti-body–technetium Tc-99m radioimmune conjugate
Status: marketed in Europe and Canada, not U.S.
Organizations involved:
Immunomedics, Inc. – Manuf.; R&D; Tech.
BAG GmbH – Manuf. other
Logosys Logistik GmbH – Europe mark.
GE Medical Systems/GE Health – Canada mark.
Lilly, Eli & Co. – Former
Teva Pharmaceutical Ind. Ltd. – Latin Amer. mark.
Teva Pharmaceutical Industries Ltd. – Parent
Cross ref: See also the entry (#305) for CD15 Mab–Tc 99m radioconj. also used for imaging of infections. See the entry for Monoclonal Antibodies (#300).
Description: Sulesomab or LeukoScan is a formulation of a murine monoclonal antibody fragment with specificity for human granulocytes (white blood cells accumulating at the sites of infection) chemically conjugated with technetium-99m radioisotope. Conjugation is performed by a direct one-step process. LeukoScan enables radiodiagnostic imaging of sites of infection within 1-4 hours using conventional nuclear cameras. The product is used for radiodiagnosis of osteomyelitis (bone infection), particularly to differentiate soft-tissue infection from osteomyelitis, and for diagnosis of equivocal appendicitis. As a newer product, sulesomab is presumed to be manufactured by hybridoma cell culture.
Nomenclature: Granulocyte Mab–Tc99m radioconj. [BIO]; LeukoScan [TR]; sulesomab [USAN]; granulocyte monoclonal antibody–technetium Tc-99m radioimmune conjugate [SY]
Companies.: LeukoScan was developed and is manufactured by Immunomedics, Inc. Eli Lilly & Co. (Germany) originally exclusively marketed the product in Europe. Teva-Tuteur, a subsidiary of Teva Pharmaceutical Industries Ltd., has marketing rights in Latin American countries. GE Healthcare Medical Diagnostics markets the product in Canada.
In Oct. 2001, Immunomedics entered into a Distribution Agreement with Logosys Logistik GmbH for packaging and distribution of LeukoScan in the European Union.
In April 2005 Immunomedics entered into an agreement with BAG GmbH (Lich, Germany) for the final formulation, fill and lyophilization of LeukoScan.
Status: A BLA for appendicitis radiodiagnostic imaging was filed with FDA on May 1, 1997, and has been reported by Immunomedics as, technically, still under consideration/pending. However, Immunomedics states that the company is no longer pursuing development of diagnostic antibody products, indicating that Leukoscan will never receive FDA approval or be marketed in the U.S.
LeukoScan has been approved and is marketed in the Europe Union, Australia, Canada and the Middle East.
European Union approval was granted on Feb. 14, 1997, for use on an emergency basis only (i.e. requested by a physician for a medical procedure).
On Dec. 17, 1998, Immunomedics, Inc. announced FDA approval (for export purposes) of LeukoScan from the company’s new manufacturing facility in Morris Plains, NJ; replacing facilities in Newark. NJ. This included a review of certain changes in manufacturing processes.
Canadian approval was granted on Jan. 19, 2005.
For a period ending Dec. 31, 2005, LeukoScan was sold in Europe on an emergency basis only (i.e. requested by a physician for a medical procedure), while European Union authorities completed their validation of manufacturing process revisions. This regulatory approval was received Jan. 30, 2006, and European has distribution resumed.
On Jan. 30, 2006, full, unrestricted European Union approval was granted for LeukoScan manufactured using revised processes.
LeukoScan is also marketed in Australia.
Trials: A Phase III trial conducted by the Leukoscan Appendicitis Clinical Trial Group showed that among 141 children and adults presenting with suspected acute, atypical appendicitis, the sensitivity and specificity of imaging with sulesomab were 91% and 92%, respectively.
Market Recent sales for LeukoScan appear to be negligible by pharmaceutical standards, ≤$10 million, with product sales and income not even reported by Immunomedics, and LeukoSite not even mentioned in a recent company presentation.
Index Terms:
Companies involvement:
Full monograph
308 Granulocyte Mab–Tc99m radioconj.
Nomenclature:
Granulocyte Mab–Tc99m radioconj. [BIO]
Leukoscan [TR]
sulesomab [USAN unconfirmed]
granulocyte monoclonal antibody labeled with technetium-99m [SY]
FDA Class: BLA biologic
antibodies (see also immune globulins; monoclonal antibodies)
biopharmaceutical products
conjugates
monoclonal antibodies
radioimmune conjugates<!-- radioconjugates -->
cementum
North American coral snake
EU200 Currently Approved in EU
UM999 Not Available/Not Marketed in US
US000 never filed/no plans
EM001 Marketed Product in EU
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