Tolero Pharmaceuticals to Be Acquired for Up to $780 Million

Tolero Pharmaceuticals to Be Acquired for Up to $780 Million December 21, 2016
By Alex Keown, BioSpace.com Breaking News Staff

OSAKA, Japan -- Sumitomo Dainippon Pharma Co. Ltd. is plunking down up to $780 million to acquire Utah-based Tolero Pharmaceuticals and its oncology therapies.

Masayo Tada, president and chief executive officer of Sumitomo, said the work being done at privately-held Tolero aligns with the Sumitomo’s therapeutic focus. He said it was the mission of “any R&D-oriented pharmaceutical company” to deliver innovative treatment options to patients and their families.

“As Tolero possesses a group of attractive development compounds, including alvocidib, we expect that this acquisition will help us to reinforce our oncology pipeline and achieve sustained growth of the Sumitomo Dainippon Pharma Group after the expiry of the exclusivity period of our mainstay atypical antipsychotic Latuda. Now that Tolero’s high drug discovery abilities are on our side, we also expect to create a continuous flow of development compounds going forward,” Tada said in a statement.

In its announcement, Sumitomo pointed to six programs in Tolero’s pipeline that have the potential to become strong revenue drivers. The programs include alvocidib, a cyclin-dependent kinase 9 (CDK9) inhibitor, aimed at hematologic malignancies. Alvocidib, which was licensed from Sanofi, is currently undergoing two Phase II trials in acute myeloid leukemia, as well as a preclinical study in Myelodysplastic syndromes with biomarkers. Tolero is aiming to file a New Drug Application with the U.S. Food and Drug Administration for alvocidib in 2018. Alvocidib has received Orphan Drug Designation in both the United States and in Europe.

Tolero also has a Phase I study of the compound TP-0903, an AXL Kinase Inhibitor for use against solid tumors. The company also has TP-1287, an oral CDK9 inhibitor, and TP-0184, an ALK2 inhibitor, in preclinical development.

Under terms of the deal, Sumitomo will make an upfront payment of $200 million to Tolero on closing of the acquisition. The acquisition is expected to be finalized in February 2017. After that payment, Tolero shareholders will receive milestone payments of up to $430 million related to progress made on the compounds being developed by Tolero. Another $150 million in milestone payments will be made following the successful commercialization of these compounds, Sumitomo said in its announcement.

Tolero, which was established in 2011, will remain the name of the company, but will be under the Sumitomo umbrella. Sumitomo said it is reviewing the financial impact of the acquisition and will make an announcement if any changes are determined before its fiscal year ends on March 31, 2017.

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