MGI Pharma, Cilag form license agreement to develop Dacogen for Injection

By Lisa Kerner

Charlotte, N.C., July 6 - MGI Pharma, Inc. signed a license agreement with Cilag GmbH, granting exclusive development and commercialization rights for Dacogen (decitabine) for Injection in all territories outside North America to Janssen-Cilag companies, members of the Johnson & Johnson family of companies.

Dacogen is a Food and Drug Administration-approved treatment for patients with myelodysplastic syndromes (MDS), the result of a defect in the blood-forming stem cells.

Cilag will pay to MGI Pharma a $10 million upfront payment, potential milestone payments of $47 million, and research and development support of $25 million over three years.

While both companies will implement a strategic plan for the global clinical development of Dacogen, MGI will retain all commercialization rights to Dacogen in North America.

Janssen-Cilag companies will conduct regulatory and commercial activities in all territories outside North America, while MGI will do the same in the activities in the United States, Canada and Mexico.

A phase 3 pivotal trial to evaluate Dacogen in patients with acute myeloid leukemia (AML) is underway, as are phase 2 studies to evaluate alternative dosing regimens for Dacogen in patients with MDS, AML and chronic myelogenous leukemia.

MGI is an oncology- and acute care-focused biopharmaceutical company located in Minneapolis.

The Janssen-Cilag companies develop and market treatments for central nervous system disorders, pain management, anemia, fungal infections and gastrointestinal conditions.

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