AbbVie will join Infinity Pharmaceuticals to develop and commercialize the latter’s lead R&D program, focused on the cancer compound duvelisib (IPI-145), the companies said today. The deal could generate up to $805 million for Infinity, which positioned itself to buy global rights to the drug about a month ago from Takeda Pharmaceutical’s Millennium subsidiary.
Duvelisib is an oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma that is now under study as a monotherapy in two trials—DYNAMO™, a Phase II study in patients with refractory indolent non-Hodgkin lymphoma (iNHL) for which patient enrollment is ongoing; and DUO™, a Phase III monotherapy study in patients with relapsed/refractory chronic lymphocytic leukemia (CLL).
A Phase I of the product in patients with advanced blood cancers is ongoing—while the Phase III study DYNAMO+R™, evaluating the combination of duvelisib plus rituximab in patients with previously treated follicular lymphoma, is expected to begin before the end of this year.
“We believe that duvelisib is a very promising investigational treatment based on clinical data showing activity in a broad range of blood cancers,” Michael Severino, M.D., AbbVie EVP and CSO, said in a statement. “The addition of duvelisib will complement AbbVie’s emerging oncology pipeline and expand our research into combination therapies to generate improved outcomes for cancer patients.”
Under their strategic collaboration, the companies will share responsibility for trials related to duvelisib, with each leading the development of certain trials. Infinity will fund the trials it conducts, while the companies will share equally in funding trials conducted by AbbVie.
The agreement includes plans to launch multiple Phase II and Phase II studies of duvelisib in blood cancers over the next several years, the companies said.
In return, AbbVie agreed to pay Inifinity $275 million upfront, plus up to $530 million in payments tied to development, regulatory, and commercial milestones. The payments include $405 million tied to milestones through the first commercial sale of duvelisib.
The companies agreed to share equally in the cost of commercializing duvelisib, as well as in any potential profits, in the U.S. However, AbbVie will oversee commercialization of the compound outside the U.S., with Infinity eligible for tiered royalties on net product sales ranging from 23.5% to 30.5%.
For U.S. sales of duvelisib, AbbVie and Infinity agreed to share equally the existing royalty obligations to Mundipharma International Corporation Limited/Purdue Pharmaceutical Products L.P., while Infinity will oversee royalty obligations for sales outside of the U.S.
Infinity will also be responsible for existing royalty obligations to Millennium: The Takeda Oncology Company for sales of duvelisib worldwide. On August 4, Infinity purchased an option for $5 million to buy out all future potential royalty payments owed Millennium for sales of IPI-145 in cancer indications. Infinity can exercise the option by providing written notice and paying Millennium $52.5 million on or before
Should Infinity exercise that option, Infinity could exclude worldwide net sales of IPI-145 in oncology from its obligation to pay Millennium tiered royalties of 7% to 11% on worldwide net sales of its first two distinct PI3K product candidates. However, Infinity would still have to pay Millennium milestone payments related to its first two approved PI3K drugs, even if one of them was IPI-145.
Those payments consist of up to $220 million in success-based regulatory milestones; up to a total $230 million in commercial milestones tied to undisclosed sales thresholds; and up to a total of
Infinity has held rights to develop PI3K drugs since securing a license from Intellikine to develop its PI3K portfolio. Takeda acquired Intellikine in 2011.