SuperGen Comments on Preliminary Efficacy Update on EORTC Phase 3 Trial of Dacogen(R) Versus Supportive Care in Patients With Myelodysplastic Syndromes
Subsequent to database lock and the completion of data analysis,comprehensive results of the study, including secondary efficacy endpoints andsafety data, will be presented by EORTC at an upcoming scientific forum.
2008 Annual Financial Guidance Update
The Company reiterates its 2008 annual financial guidance provided duringthe 2008 first quarter financial conference call on April 28, 2008. Asindicated in the 2008 first quarter financial conference call, the Companyexpects to report royalty revenue for 2008 in a range from $32 million to $35million. Also, the Company continues to estimate a loss from operations for2008 in a range from $17 million to $19 million.
The Company's financial position at March 31, 2008 included approximately$91 million in unrestricted cash, cash equivalents and marketable securitiesand no debt.
This Phase 3 open-label, randomized, multicenter, controlled trialevaluated overall survival of patients receiving Dacogen plus BSC versus BSConly. The study involved 233 elderly patients, greater than or equal to 60years of age, with predominantly high-risk or Intermediate-2 type MDS.
Patients included in the trial had primary or secondary MDS, with orwithout previous therapy with growth factors, immunosuppressive agents orhydroxyurea. In order to participate in the study, patients had to have bonemarrow blast counts between 11 and 30 percent. Patients with blast countsbelow 10 percent were required to have had poor prognosis cytogenetics inorder to be eligible for randomization.
Myelodysplastic syndromes, or MDS, is a bone marrow disorder characterizedby the production of poorly functioning and immature blood cells. People withMDS may experience a variety of symptoms and complications, including anemia,bleeding, infection, fatigue and weakness. Those patients with high-risk MDSmay experience bone marrow failure, which may lead to death from bleeding andinfection. Over time, MDS can progress to acute myelogenous leukemia (AML).The Aplastic Anemia and MDS International Foundation currently estimates thatup to 30,000 new cases of MDS are diagnosed annually in the Unites States.
Dacogen(R) (decitabine) for Injection was developed through a pivotalPhase 3 study by SuperGen and partnered to MGI PHARMA, INC. (acquired by EisaiCo., Ltd.). MGI PHARMA subsequently sublicensed all Dacogen rights outside ofNorth America to Janssen-Cilag, a Johnson & Johnson Company. Dacogen wasapproved by the U.S. Food and Drug Administration on May 2, 2006 and isindicated for the treatment of patients with MDS, including previously treatedand untreated, de novo and secondary MDS of all French-American-British (FAB)subtypes (refractory anemia, refractory anemia with rings sideroblasts,refractory anemia with excess blasts, refractory anemia with e
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