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news.Infinity Pharmaceuticals has purchased an option to buy out all future potential royalty payments due to Millennium: The Takeda Oncology Company for sales in oncology of IPI-145, Infinity’s oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma.
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In exchange for a one-time, upfront payment of $5.0 million, Infinity receives an option to terminate its obligation to pay Millennium future royalties related to the sale of IPI-145 in oncology. Infinity may exercise this option by providing written notice and payment to Millennium of a one-time exercise fee of $52.5 million on or before March 31, 2015.
Exercise of the option does not affect any other obligation under the Development and License Agreement, including Infinity’s obligation to pay royalties on sales of IPI-145 outside of oncology. If Infinity does not exercise the option, its royalty obligations with respect to IPI-145 in oncology will remain in effect.
Assuming exercise of the option, Infinity’s obligation to pay Millennium tiered royalties, ranging from seven percent to 11 percent, on worldwide net sales of Infinity’s first two distinct PI3K product candidates will exclude worldwide net sales of IPI-145 in oncology. Infinity will remain obligated to pay milestones to Millennium for Infinity’s first two distinct PI3K product candidates that gain approval, including IPI-145.
The remaining milestones comprise up to a total of $220 million in success-based regulatory milestones, up to a total of $230 million in commercial milestones which are due once certain sales thresholds have been met, and up to a total of $5 million in development milestones.
Infinity is developing IPI-145, an oral inhibitor of Class I PI3K-delta,gamma. The PI3Ks are a family of enzymes involved in multiple cellular functions, including cell proliferation and survival, cell differentiation, cell migration and immunity.
The PI3K-delta,gamma isoforms are preferentially expressed in leukocytes (white blood cells), where they have distinct and mostly non-overlapping roles in immune cell development and function. Targeting PI3K-delta and PI3K-gamma may provide multiple opportunities to develop differentiated therapies for the treatment of hematologic malignancies as well as inflammatory diseases.
In 2013, Infinity launched the DUETTS program, a worldwide investigation of IPI-145 in blood cancers.
As part of the DUETTS program, patient enrollment is ongoing in DYNAMO, a Phase 2 monotherapy study designed to evaluate the safety and efficacy of IPI-145 in patients with refractory indolent non-Hodgkin lymphoma (iNHL) (ClinicalTrials.gov Identifier NCT01882803), and DUOTM, a Phase 3 monotherapy study designed to evaluate the safety and efficacy of IPI-145 in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) (NCT02004522). DYNAMO+RTM, a Phase 3 study of IPI-145 in combination with rituximab in relapsed iNHL (NCT02204982), is expected to start in 2014.
Additionally, a Phase 1 study of IPI-145 in patients with advanced blood cancers is ongoing (NCT01476657).