MGI Pharma Boosts Hematology Pipeline With AkaRx Agreement
This article was originally published in The Pink Sheet Daily
Executive Summary
Phase II thrombocytopenia candidate AKR-501 has revenue potential in excess of $1 billion in the U.S., MGI says.
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MGI Pharma has signed an agreement with AkaRx gaining rights to develop and commercialize AKR-501, a novel oral small molecule in Phase II for the treatment of thrombocytopenia, MGI announced Aug. 28. Under the agreement, MGI also has an option to acquire AkaRx for $255 million at any time up to Jan. 8, 2010, and rights to AKR-201, a metabolite of thyroid hormone in preclinical testing as a treatment for thyroid cancer. MGI will make up-front aggregate payments of $45 million for the licenses and option rights. No additional royalties are part of the deal. AKR-501 is a thrombopoietin mimetic agonist targeting the c-Mpl receptor on platelet-producing cells to stimulate platelet production. While the compound is in Phase II trials for idiopathic thrombocytopenic purpura, MGI says it will pursue other indications such as hepatitis C-related and chemotherapy-induced thrombocytopenias and myelodysplastic syndrome. Phase III studies are expected to begin within the next 18 months. Minneapolis-based MGI already markets Dacogen (decitabine) for treatment of myelodysplastic syndromes. The firm's therapeutic focus is on acute care and oncology (1 (Also see "Pharmion Vidaza Phase III Shows First Survival Advantage In Patients With High-Risk Myelodysplastic Syndromes" - Pink Sheet, 2 Aug, 2007.)). It also markets Aloxi (palonosetron hydrochloride) for chemotherapy-induced nausea and vomiting and is in Phase III for Aquavan (fospropofol disodium) injection, a prodrug of propofol for mild to moderate sedation during diagnostic and therapeutic procedures. It expects to file an NDA this quarter and to launch the product during the second half of 2008. AKR-501 is an "excellent fit" commercially, MGI CEO Lonnie Moulder said in a same-day conference call with investors. "The target audience for our field force for the treatment of ITP and MDS would be hematologists, physicians with whom we have an excellent relationship due to our promotional and scientific activities and support of the successful Dacogen and Aloxi franchises," he said. MGI's existing sales force also calls on medical oncologists. Assuming the launch of Aquavan is on target, MGI also will be expanding its sales organization to target gastroenterologists and hepatologists, Moulder noted. AKR-501 has several characteristics that could potentially position it as best-in-class therapy for thrombocytopenia, MGI said. It does not compete with thrombopoietin for binding to the c-Mpl receptor and it does not activate or aggregate platelets. It is oral with a long half-life that could enable once-daily dosing. In addition, it appears that the compound could be taken with or without food. "Certain of the competitive agents possess some, but none possess all of these key attributes," MGI Exec VP and Chief Scientific Officer Mary Lynne Hedley said during the call. Products under development for the treatment of thrombocytopenia include GlaxoSmithKline's Promacta (eltrombopag) in Phase II and III trials and 559448 in Phase I (2 (Also see "GSK’s Eltrombopag Improves ITP In Phase II Results" - Pink Sheet, 19 Jun, 2006.)). Amgen is developing a thrombopoiesis stimulating Fc-peptide fusion protein that activates Mpl, currently in Phase III for ITP and Phase II for CIT and MDS. - Pamela Taulbee ([email protected]) |