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Cintredekin Besudotox

INSYS Therapeutics, Inc.

Drug Names(s): IL13-PE38QQR

Description: Cintredekin Besudotox is a tumor-targeting agent administered by a continuous infusion directly into the brain around the cavity where the tumor has been removed. Cintredekin Besudotox is made by combining a human protein (IL13) with a portion of a bacterial toxin protein, Pseudomonas Exotoxin (PE). The IL13 portion binds to receptors on the tumor like a “key to a lock,” allowing the PE portion to enter and kill those cells. Since tumor cells preferentially bind the drug, normal (healthy) brain cells are much less likely to be damaged by the drug. Cintredekin Besudotox is delivered through tubing or catheters placed directly into the area surrounding the resection cavity. These catheters are surgically placed from 2-7 days after the tumor has been removed. A pump is then used to slowly deliver the drug through the catheters using convection-enhanced delivery (CED) over a period of 4 days.

For IPF (idiopathic pulmonary fibrosis), NeoPharm's studies in animals and human tissue have shown that the receptors for interleukin 13 (IL13) are significantly over-expressed in pulmonary fibroblasts. IL13-PE has demonstrated selective cytotoxicity to the IL13 receptor-expressing fibroblasts, thereby ameliorating the histopathological evidence of IPF in animal models.

Deal Structure: NeoPharm and NIH
In September 1997, NeoPharm entered into an exclusive worldwide licensing agreement with the National Institutes of Health (NIH) whereby it was granted the right to develop and commercialize cintredekin besudotox for the treatment of cancer. The cintredekin besudotox license also required Neopharm to pay to NIH milestone payments of up to $585,000 upon completion of various phases of development of cintredekin besudotox and a maximum royalty of 4% based on future product sales. The license agreement terminates in 2018.

In June 2007, Neopharm entered into an exclusive patent license agreement with the National Institutes of Health (NIH) for the development of Cintredekin Besudotox for the treatment of Pulmonary Fibrosis and asthma.

In October 2008, NeoPharm announced that the Company has signed a Cooperative Research and Development Agreement (CRADA) with the National Institute of Neurological Diseases and Stroke (NINDS), a part of the National...See full deal structure in Biomedtracker

Partners: Nippon Kayaku Co., Ltd.

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