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Diosynth Biotechnology (Research Triangle Park) Announces Amendment To Validation And Manufacturing Agreement With NeoPharm (NEOL) For IL13-PE38QQR


10/19/2005 5:12:28 PM

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Sept. 21, 2005--Diosynth Biotechnology today announced that it has agreed to an amendment of the current agreement it has with NeoPharm, Inc. (NASDAQ: NEOL) to provide for Diosynth's performing validation and conformance lot manufacturing of NeoPharm's cintredekin besudotox (IL13-PE38QQR) drug candidate in the event NeoPharm is able to move forward with a Biologic License Application (BLA) at the conclusion of its pivotal Phase III PRECISE trial for cintredekin besudotox. Frank Tielens, Diosynth Biotechnology's President, expressed his gratitude to NeoPharm "for the continued trust shown in us as their contract manufacturer. This decision was supported by our successful track record producing IL 13-PE38QQR for use in their Phase I/II and Phase III "PRECISE" clinical trial for the treatment of glioblastoma multiforme." Further, Mr. Tielens indicated that Diosynth Biotechnology will use its expertise in process and analytical methods development for the validation of this biotechnology process.

Read at BioSpace.com


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