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Infinity Pharmaceuticals, Inc. recently announced that the company amended its development and license agreement with Millennium: The Takeda Oncology Company and Takeda Pharmaceutical Company Limited for Infinity’s phosphoinositide-3-kinase (PI3K) program. Under the amended agreement, Infinity continues to retain full worldwide rights to IPI-145, a potent, oral inhibitor of PI3K-delta and PI3K-gamma, as well as worldwide rights to any future product candidates targeting PI3K-delta and/or PI3K-gamma, and Millennium remains entitled to receive success-based milestones and tiered royalties on future worldwide sales of products covered by this agreement.

In exchange for Infinity’s one-time payment of $15 million, Millennium waived its right to opt into a 50/50 US profit and loss-sharing arrangement in the US for any of Infinity’s PI3K inhibitors, including IPI-145. In addition, Infinity paid Millennium the $5-million development milestone for the August 2012 initiation of the Phase IIa clinical trial of IPI-145 in patients with asthma.

“We believe that the potency of IPI-145 against both PI3K-delta and PI3K-gamma contribute to its potential to become the best-in-class PI3K inhibitor,” added Lawrence Bloch, MD, JD, Executive Vice President, Chief Financial Officer and Chief Business Officer of Infinity. “Infinity is focused on rapidly advancing IPI-145 and additional follow-on PI3K product candidates with the goal that patients, our shareholders, and other financial stakeholders, including Millennium, will benefit from their development and commercialization.”

“We have had a successful relationship with Infinity since the December 2011 acquisition of Intellikine by Takeda Pharmaceutical Company Limited,” stated Kyle Kuvalanka, Vice President, Business Development and Corporate Strategy and Development of Millennium. “We look forward to Infinity’s continued progress and to participating in the downstream value of its PI3K program through future milestone and royalty payments.”

Under the terms of the amended agreement, Infinity continues to retain worldwide development and commercialization rights for its PI3K-delta,gamma program. In exchange for Infinity’s one-time payment of $15 million, Millennium waived its right to opt into a 50/50 US profit and loss-sharing arrangement and its right to participate in up to 30% of the detailing effort in the US for any of Infinity’s PI3K inhibitors. In addition, Infinity paid Millennium the $5-million milestone for the August 2012 initiation of the Phase IIa trial of IPI-145 in patients with asthma.

For Infinity’s first two distinct PI3K product candidates, Millennium is entitled to receive up to $15 million in remaining success-based development milestones and up to $450 million in success-based approval and commercial milestones, as defined in the original agreement. For all of Infinity’s PI3K-delta and/or PI3K-gamma inhibitors covered under the agreement, Infinity is obligated to pay Millennium tiered royalties on worldwide net sales ranging from 7% to 11%, which are the same royalty levels as those specified under the original agreement.

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 and PI3K-gamma isoforms are preferentially expressed in leukocytes, where they have distinct and 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 inflammatory diseases as well as hematologic malignancies.

Infinity is developing a portfolio of novel PI3K-delta and/or PI3K-gamma inhibitors in both inflammatory diseases and oncology. IPI-145 is currently progressing in a Phase I trial in patients with advanced hematologic malignancies and in a Phase IIa trial in patients with mild, allergic asthma. Infinity is also planning to begin a Phase II trial of IPI-145 in patients with rheumatoid arthritis in the first half of 2013. Infinity expects to name its first follow-on PI3K development candidate by the end of this year and is planning to complete nonclinical studies, which are designed to enable Phase I development, by the end of 2013. For more information, visit www.infi.com.

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