DEERFIELD, Ill.—Baxter International Inc. and OnconovaTherapeutics, Inc. have signed a European licensing agreement for rigosertib, anovel targeted anti-cancer compound currently undergoing a Phase III study as atreatment for a group of rare hematological malignancies known asMyelodysplastic Syndromes (MDS) as well as a Phase II/III study in pancreaticcancer.
Per the terms of the agreement, Baxter will be grantedcommercialization rights in the European Union as well as other countries inEurope, for which it will make an upfront payment to Onconova of $50 million,to be recorded as a special pre-tax in-process research and development chargein the third quarter of this year. Onconova is also eligible to receive up to$515 million in pre-commercial development and regulatory milestones for theMDS and pancreatic cancer indications, as well as sales milestones androyalties. Baxter has an equity investment of $50 million with Onconova, andalso has the option to participate in developing and commercializing rigosertibin additional indications.
''We look forward to working closely with Baxter with theshared goal of providing this therapy to patients in Europe,'' Ramesh Kumar,CEO of Onconova, said in a press release. ''The financial resources resultingfrom this transaction will help to advance the rigosertib program towardcommercialization and will support other Onconova candidates in clinicaldevelopment including Ex-RAD, a radioprotectant, and ON 013105, our secondnovel anti-cancer agent.''
Rigosertib works by targeting dual pathways, PI-3K and PLK,which are instrumental in the growth of cancer cells. The compound has beenstudied in more than 600 patients worldwide, demonstrating activity in treatingsolid tumors and hematological malignancies. Rigosertib is undergoingevaluation in a Phase III clinical trial in 270 MDS patients who have failed orrelapsed after having undergone current therapeutics options. Initial resultsfrom the study are expected in the second half of 2013. The compound is alsobeing evaluated in a Phase II/III combination study in patients suffering frommetastatic pancreatic cancer who have not received treatment before. An oralformulation of the compound is being tested in a Phase II study intransfusion-dependent low or intermediate-1 risk MDS patients. Onconova hasbeen granted orphan drug status for MDS in the United States and Europe.
''Rigosertib's first anticipated indication would be anatural complement to Baxter's existing treatments for patients managing rare hematologicconditions, and will allow us to expand the product portfolio of our existinghematologic sales force,'' Ludwig Hantson, Ph.D., president of Baxter'sBioScience business, said in a statement. ''Our collaboration with Onconovawill allow us to further expand our pipeline and extend our legacy in diseaseareas with critical needs.''
A largevariety of bone marrow disorders fall under the umbrella of MDS, each of which come withheightened risks of bleeding and infection, as well as an increased risk of progressionto acute myeloid leukemia. Paitnes generally require multiple bloodtransfusions and significant supportive care for disease management, withextremely poor survival rates. The incidence of MDS in Europe each year isapproximately 3 per 100,000 people, with the majority of diagnoses occurring inadults over 60 years of age.
SOURCE: Baxter press release