DUBLIN, Calif., July 6 /PRNewswire-FirstCall/ -- SuperGen, Inc. , announced the achievement of a milestone as a result of the licensing of Dacogen(TM) (decitabine) for Injection by MGI PHARMA to Cilag GmbH, a Johnson & Johnson (JNJ) company, granting exclusive development and commercialization rights in all territories outside North America. Dacogen is a treatment for patients with myelodysplastic syndromes (MDS) which occur when there is a defect in the blood-forming stem cells, resulting in too few and poorly functioning blood cells. SuperGen will receive 50% of the $10 million upfront payment and as a result of both the original agreement with MGI PHARMA and this sublicense with Cilag GmbH up to $23.75 million in future milestone payments as they are achieved for Dacogen globally. Additionally, SuperGen will receive the 20% to 30% royalty on all sales worldwide.
"Janssen-Cilag companies have established a record of success in the field of hematology," said Dr. James Manuso, President and CEO of SuperGen. "The combination of MGI PHARMA and Janssen-Cilag as global developers and marketers of Dacogen should accelerate the availability of this product to patients worldwide."
MGI PHARMA and the Janssen-Cilag companies will jointly implement a strategic plan for the global clinical development of Dacogen. Under the terms of this agreement, MGI PHARMA will retain all commercialization rights to Dacogen in North America. Janssen-Cilag companies will be responsible for conducting regulatory and commercial activities related to Dacogen in all territories outside North America, while MGI PHARMA retains all responsibility for all activities in the United States, Canada and Mexico.
About Dacogen(TM) (decitabine) For Injection
Dacogen(TM) (decitabine) for Injection was approved by the U.S. Food and Drug Administration on May 2 and is indicated for treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British (FAB) subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia), and Intermediate-1, Intermediate-2 and High-Risk International Prognostic Scoring System (IPSS) groups. Dacogen may cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant while using Dacogen. Men should be advised not to father a child while receiving treatment with Dacogen and for 2 months afterwards. The most commonly occurring adverse reactions with Dacogen include neutropenia (90%), thrombocytopenia (89%), anemia (82%), pyrexia (53%), fatigue (48%), nausea (42%), cough (40%), petechiae (39%), constipation (35%), and diarrhea (34%). Please visit http://www.mgipharma.com for full prescribing information.
MGI PHARMA is currently conducting a phase 3 pivotal trial to evaluate Dacogen in patients with acute myeloid leukemia, or AML. Additional phase 2 studies are also underway to evaluate alternative dosing regimens for Dacogen in patients with MDS and in patients with AML and chronic myelogenous leukemia, or CML. A phase 3 EORTC-sponsored study of Dacogen in patients with MDS is ongoing in Europe.
Based in Dublin, California, SuperGen is a pharmaceutical company dedicated to the discovery, acquisition, rapid development and commercialization of therapies for solid tumors and hematological malignancies. SuperGen is developing a number of therapeutic anticancer products focused on inhibitors of aurora-A, tyrosine kinase and DNA methyltransferase. For more information about SuperGen, please visit http://www.supergen.com.
This news release contains certain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as "believes," "expects," "anticipates," "intends," "will," "may," "should," or similar expressions. These forward-looking statements are not guarantees of future performance and involve a number of risks and uncertainties that may cause actual results to differ materially from the results discussed in these statements. Factors that might cause the company's results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, the ability of Dacogen to receive marketing authorization from regulatory authorities and to ultimately compete successfully with other therapies, and other risks and uncertainties detailed from time to time in the company's filings with the Securities and Exchange Commission including its most recently filed Form 10-Q or 10-K. SuperGen, Inc. undertakes no duty to update any of these forward-looking statements to conform them to actual results.
Timothy L. Enns
S.V.P., Corporate Communications & Business Development
Tel: (925) 560-0100 x111
Director of Investor Relations
Tel: (212) 845-4271
CONTACT: Timothy L. Enns, S.V.P., Corporate Communications & BusinessDevelopment of SuperGen, +1-925-560-0100 x111, or firstname.lastname@example.org; orSharon Weinstein, Director of Investor Relations, +1-212-845-4271, or,email@example.com, of Noonan Russo for SuperGen, Inc.