Baxter, Onconova ink licensing agreement
DEERFIELD, Ill.óBaxter International Inc. and Onconova Therapeutics, Inc. have signed a European licensing agreement for rigosertib, a novel targeted anti-cancer compound currently undergoing a Phase III study as a treatment for a group of rare hematological malignancies known as Myelodysplastic Syndromes (MDS) as well as a Phase II/III study in pancreatic cancer.
Per the terms of the agreement, Baxter will be granted commercialization rights in the European Union as well as other countries in Europe, 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 charge in the third quarter of this year. Onconova is also eligible to receive up to $515 million in pre-commercial development and regulatory milestones for the MDS and pancreatic cancer indications, as well as sales milestones and royalties. Baxter has an equity investment of $50 million with Onconova, and also has the option to participate in developing and commercializing rigosertib in additional indications.
''We look forward to working closely with Baxter with the shared goal of providing this therapy to patients in Europe,'' Ramesh Kumar, CEO of Onconova, said in a press release. ''The financial resources resulting from this transaction will help to advance the rigosertib program toward commercialization and will support other Onconova candidates in clinical development including Ex-RAD, a radioprotectant, and ON 013105, our second novel 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 been studied in more than 600 patients worldwide, demonstrating activity in treating solid tumors and hematological malignancies. Rigosertib is undergoing evaluation in a Phase III clinical trial in 270 MDS patients who have failed or relapsed after having undergone current therapeutics options. Initial results from the study are expected in the second half of 2013. The compound is also being evaluated in a Phase II/III combination study in patients suffering from metastatic pancreatic cancer who have not received treatment before. An oral formulation of the compound is being tested in a Phase II study in transfusion-dependent low or intermediate-1 risk MDS patients. Onconova has been granted orphan drug status for MDS in the United States and Europe.
''Rigosertib's first anticipated indication would be a natural complement to Baxter's existing treatments for patients managing rare hematologic conditions, and will allow us to expand the product portfolio of our existing hematologic sales force,'' Ludwig Hantson, Ph.D., president of Baxter 's BioScience business, said in a statement. ''Our collaboration with Onconova will allow us to further expand our pipeline and extend our legacy in disease areas with critical needs.''
A large variety of bone marrow disorders fall under the umbrella of MDS, each of which come with heightened risks of bleeding and infection, as well as an increased risk of progression to acute myeloid leukemia. Paitnes generally require multiple blood transfusions and significant supportive care for disease management, with extremely poor survival rates. The incidence of MDS in Europe each year is approximately 3 per 100,000 people, with the majority of diagnoses occurring in adults over 60 years of age.
SOURCE: Baxter press release