MGI Pharma, Inc., a biopharmaceutical company focused in oncology and acute care, has entered into agreements with AkaRx, Inc., for AKR-501, a novel, orally-available, small molecule thrombopoietin mimetic being developed for the treatment of thrombocytopenia.
AKR-501 is a full agonist that targets the c-Mpl receptor on platelet producing cells to stimulate platelet production. Under the terms of the agreements, MGI Pharma has obtained the rights to develop AKR-501, and an option to acquire AkaRx, at MGI's sole discretion, at any time up to January 8, 2010.
"AKR-501 is an ideal commercial and therapeutic fit within our oncology and acute care franchises, and our research and development team is ready to advance these programs following the planned submission of the Aquavan NDA this quarter" stated Lonnie Moulder, president and chief executive officer of MGI Pharma. "We are pleased to have obtained the rights to this advanced-stage product with significant revenue potential that is being developed for multiple indications. AKR-501 provides MGI Pharma with a tremendous opportunity for sustained revenue growth in future years, with US peak revenue potential exceeding $1 billion."
AKR-501 is currently being evaluated in a phase 2 trial for the treatment of idiopathic thrombocytopenic purpura (ITP), and the company expects to initiate a phase 3 trial in this disorder within the next 18 months. MGI Pharma will initiate phase 2 trials in patients with hepatitis-C-related thrombocytopenia and chemotherapy-induced thrombocytopenia (CIT) over the next several quarters, and evaluate other applications of AKR-501, including treatment of MDS.
Under the terms of the transaction with AkaRx, MGI Pharma expects to make upfront aggregate payments of up to $45 million to obtain the license rights and the options to acquire all of AkaRx's capital stock from AkaRx shareholders at any time prior to January 8, 2010. The development and license agreement provides that MGI will assume responsibility for certain development activities during the option period. There are no additional milestone payments, and, if AKR-501 is commercialized