Eisai, TSD Japan Seal License, Development Agreement For Denileukin Diftitox

Published: 28-Oct-2009

Denileukin diftitox, a solution for intravenous injection for the treatment of patients with cutaneous T-cell lymphoma

Eisai and TSD Japan has entered into a license and joint development agreement for the development of denileukin diftitox (generic name) in Japan. Under the terms of the agreement, Eisai shall grant TSD the exclusive right to co-develop the drug in Japan, while Eisai will retain the exclusive right to market the product once marketing authorisation has been granted.

Denileukin diftitox is a solution for intravenous injection for the treatment of patients with cutaneous T-cell lymphoma (CTCL), whose malignant cells express the CD25 component of the interleukin (IL)-2 receptor (CD25+).

Reportedly, in February 1999, the drug was granted accelerated approval as a biological product in the US by the FDA under Subpart E, an FDA regulation. Denileukin diftitox has been granted orphan drug status in the US and is currently marketed by Eisais US subsidiary under the brand name of Ontak.

As per the agreement, Eisai and TSD will work closely together in an effort to meet unmet medical needs and will expedite the development of the drug so as to bring a new treatment option to patients with CTCL and healthcare professionals as early as possible.

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