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A match made in MDS
DEERFIELD, Ill.—In keeping with the rise of orphan disease-focused partnerships, Baxter International Inc. and Onconova Therapeutics Inc. have announced the signing of a European licensing agreement for rigosertib, a novel targeted anti- cancer compound that is currently being evaluated in a Phase III study for the treatment of Myelodysplastic Syndromes (MDS), a group of rare hematological malignancies, and in a Phase II/III study for pancreatic cancer.
Per the agreement, Baxter will pay Onconova $50 million upfront, for which it will receive commercialization rights in the European Union and other countries in Europe. If certain precommercial development and regulatory milestones are met for the initial indications, Onconova stands to receive up to $515 million in milestone payments, as well as sales milestones and royalties. Baxter will have the option to participate in developing and commercializing rigosertib in additional indications, and has an existing equity investment with Onconova of $50 million.
"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," Dr. Ludwig Hantson, president of Baxter's BioScience business, said in a press release. "Our collaboration with Onconova will allow us to further expand our pipeline and extend our legacy in disease areas with critical needs."
A spokesman for Baxter said the company was attracted to Onconova as a partner because the Newtown, Pa.-based company "demonstrated very strong potential to build a broader relationship beyond the anticipated EU licensing opportunity." The agreement, they add, allows Baxter "to further expand our pipeline and extend our legacy in disease areas with critical needs by focusing resources on a potential solution for MDS and pancreatic cancer, two conditions with very limited options today."
Rigosertib targets two pathways—PI-3k and PLK—known to play significant roles in the growth of cancer cells, and has demonstrated activity in treating solid tumors as well as hematological malignancies. The compound's current Phase III trial consists of 270 MDS patients who have failed or relapsed after undergoing current treatment options, and results are expected in the second half of next year. The Phase II/III trial is testing rigosertib in patients with previously untreated metastatic pancreatic cancer, and an oral formulation of the compound is being evaluated in a Phase II study in transfusion-dependent low or intermediate-1 risk MDS patients. So far, Onconova has secured orphan drug designation for MDS in the United States and Europe, and for pancreatic cancer in the United States.
Ramesh Kumar, CEO of Onconova, says Baxter emerged as "almost a perfect match for the product and for us," given the pharma's "strong legacy in hematology," its interest in growing its oncology business and the fact that nearly a third of its revenue comes from its dealings in Europe.
"They have a strong commercial presence in Europe, they have a strong desire in oncology and most of all, they 're a specialist in hematology. The more we looked into it—and because we wanted to do a regional partnership, not a global one—Baxter appeared to us ideally suited as a partner," says Kumar.
He notes that the partnership enhances Onconova's pipeline and "reinforces our commitment to cancer in general," noting that "rigosertib, because of its mechanism, is potentially very widely useful." Additional potential indications include other hematological cancers such as acute myeloid leukemia (AML), and solid tumors such as ovarian cancer and head and neck cancer, he adds.
"The only way we can maximize the potential of the drug is first to get it approved and secondly to expand the utility by doing additional trials," says Kumar. "And our relationship with Baxter, as well as our relationship with SymBio and the Leukemia & Lymphoma Society, enables us to broadly explore the potential value of the drug by focusing on the speedy approval for the first indication in MDS."
MDS encompasses a variety of bone marrow disorders associated with increased risk of bleeding, infection and progression to AML. Patients often require multiple blood transfusions and significant supportive care and face poor survival rates, with an annual incidence in Europe of roughly three per 100,000 people. Pancreatic cancer is highly aggressive and difficult to diagnose early due to vague symptoms. The disease has a low survival rate, and recent estimates place the mortality rate in Europe between eight in 100,000 in men and five in 100,000 in women.