MGI Pharma Inc and SuperGen Inc have signed a definitive agreement granting MGI Pharma exclusive worldwide rights to the development, manufacture, commercialization and distribution of Dacogen (decitabine), SuperGen's investigational anti-cancer therapeutic for the treatment of patients with myelodysplastic syndromes (MDS).
Under the terms of this agreement, MGI Pharma will make a $40 million equity investment in SuperGen at $10.00 per share and will pay SuperGen up to $45 million based upon achievement of specified regulatory and commercialization milestones. SuperGen will continue with its filing of the MDS applications for regulatory approval in the US and Europe with assistance from MGI Pharma, according to a release.
SuperGen will receive a royalty on worldwide net sales starting at 20 per cent and escalating to a maximum of 30 per cent. MGI Pharma has also committed to fund further development costs associated with Dacogen, at a minimum of $15 million. The transaction is subject to customary closing conditions and regulatory approval. Additional financial terms and details of the agreement were not disclosed, the release added.
"We are very pleased to announce this agreement with SuperGen and to advance the development of this important product candidate, Dacogen," Lonnie Moulder, president and CEO of MGI Pharma said adding, "We believe that it may eventually offer patients with a variety of haematologic cancers an important treatment option."
"MGI Pharma is a strong commercialization partner for Dacogen, and we are very pleased to have reached this agreement," said Dr. James Manuso, President and Chief Executive Officer of SuperGen. "We believe Dacogen now has the resources and support of a premier oncology biopharmaceutical company with the expertise to facilitate it reaching the cancer patients who most need it as expeditiously as possible," he added.
SuperGen completed phase III clinical trials of Dacogen in patients with MDS in March 2004. SuperGen and MGI will collaborate on the regulatory development process for Dacogen in MDS, and SuperGen expects to complete the NDA filing within the first 30 days of the fourth quarter of 2004.
MGI Pharma plans to evaluate Dacogen for further development in several additional indications, including acute myeloid leukaemia (AML), chronic myelogenous leukaemia (CML), and sickle cell anaemia, as well as its use in combination with other anticancer agents for the treatment of various solid tumours. Alternative dosing schedules for Dacogen, including subcutaneous administration and more rapid intravenous infusions, are currently being evaluated in clinical studies.