Baxter is paying Onconova $50 million up front for European rights to the latter’s targeted anticancer therapy rigosertib, which is undergoing Phase III trials against myelodysplastic syndromes (MDS), and Phase II/III studies in patients with pancreatic cancer.
Baxter already has a $50 million equity investment in Onconova. The deal gives Baxter commercialization rights to the drug in the EU and other European countries, and Onconova could receive up to $515 million in precommercial development and regulatory milestones for both the MDS and pancreatic cancer indications, plus sales milestones and royalties. Baxter retains an option to participate in the development and commercialization of rigostertib for other indications.
“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 hematological sales force,” states Ludwig Hantson, Ph.D., president of Baxter’s bioscience business.
Rigosertib targets the PI3K and PLK pathways critical to cancer cell growth. Initial results from the Phase III trial in 270 MDS patients who have relapsed or failed to respond to current therapeutic options are expected in the second half of 2013. An oral formulation of rigosertib is separately being evaluated in a Phase II trial in transfusion-dependent low or intermediate-1 risk MDS patients.
Onconova is developing drugs for the treatment of cancer and radiation injury. The firm’s clinical pipeline includes ON 013105, a targeted therapeutic in Phase I development against mantle cell lymphoma. Phase I trials have also been undertaken with Ex-RAD, biodefense candidate designed to protect against ionizing demonstration. Ex-RAD isn’t a free radical scavenger, chelator, or cell cycle arrestor, Onconova claims, but exhibits a novel mechanism of action that involves boosting cellular DNA repair pathways and key elements of the DNA damage cascade in response to radiation. The candidate is being developed both for prophylactic and therapeutic use.