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August 4, 2014
16:15 EDTINFIInfinity Pharmaceuticals amends PI3K-Delta, Gamma agreement with Millenium
Infinity Pharmaceuticals announced that the company 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, or PI3K-delta and PI3K-gamma. In exchange for a one-time, upfront payment of $5.0M, 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 $52.5M 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 7%-11%, 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 $220M in success-based regulatory milestones, up to a total of $230M in commercial milestones which are due once certain sales thresholds have been met, and up to a total of $5M in development milestones.
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October 16, 2014
07:41 EDTINFIInfinity reports duvelisib Phase 2a primary endpoint not met
Infinity Pharmaceuticals announced encouraging topline data from its Phase 2a exploratory study of duvelisib, or IPI-145. Data from this randomized, double-blind, placebo-controlled, cross-over study demonstrated that duvelisib was well tolerated and met several secondary and exploratory endpoints in an allergen challenge study. Clinical improvement was observed in the late-phase asthmatic response FEV1 among patients who received duvelisib administered at the highest dose tested, 25 mg twice daily for five days, however the primary endpoint of the study was not met as it did not reach statistical significance. Multiple secondary clinical endpoints measuring improvements in lung function following duvelisib administration were achieved with statistical significance and were associated with changes in key cytokines and chemokines involved in the asthmatic response. Taken together, these data demonstrate early proof-of-activity in this allergen challenge study. Infinity expects to present the final data in a peer-reviewed setting after all analyses are complete. In addition, the company anticipates determining its next steps for development of PI3K-delta,gamma inhibitors in inflammation after evaluating the results from the ASPIRA study in rheumatoid arthritis, which are expected by the end of 2014.
October 13, 2014
13:05 EDTINFIInfinity Pharmaceuticals management to meet with ISI Group
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