Mundipharma Commits to Providing Up to $110 Million in R&D Funding for 2012 in Addition to $85 Million Previously Committed for 2011
Companies Agree Upon Event-Based Approach for IPI-926 Funding Commitments Beyond 2012
CAMBRIDGE, Mass., Dec. 13, 2010 (GLOBE NEWSWIRE) -- Infinity Pharmaceuticals, Inc. (Nasdaq:INFI) today announced the extension of its global strategic alliance with Mundipharma International Corporation Limited to develop and commercialize IPI-926, Infinity's novel Smoothened antagonist, as well as development candidates arising from Infinity's phosphoinositol-3-kinase (PI3K) and discovery programs. In conjunction with this extension, Mundipharma has expanded the committed research and development funding of $85 million for 2011 to include an additional $110 million for 2012. This continued funding reflects the clinical and commercial potential of Infinity's pipeline as well as the progress made across Infinity's discovery and clinical programs since the alliance began in 2008.
Infinity also announced today that its agreement with Mundipharma was amended to align funding commitments for IPI-926 beyond 2012 with anticipated clinical events. Pursuant to this amendment, Mundipharma's next funding commitment for IPI-926 will occur after Infinity's end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) pertaining to the ongoing study of IPI-926 in patients with pancreatic cancer, as opposed to the current annual calendar-based renewal.
"Our relationship with Mundipharma provides us with the financial resources and independence to aggressively pursue our goal of developing our pipeline of novel drug candidates and gives us the opportunity to commercialize our own products in the U.S.," stated Adelene Q. Perkins, president and chief executive officer of Infinity. "Mundipharma and Purdue have been wonderful partners, and we are pleased to continue working together to bring important new medicines to patients."
"We see tremendous promise in Infinity's pipeline in cancer, inflammation and pain, as evidenced by the potential for IPI-926, a potentially new approach for treating pancreatic cancer and a broad range of other cancers," said Thomas Mehrling, M.D., director of European oncology at Mundipharma. "We look forward to continuing our productive partnership and expect that it will give us the opportunity to bring to market a number of innovative, best-in-class treatments for patients."
Details of the Global Strategic Alliance
Infinity entered into a strategic alliance with Purdue and Mundipharma in 2008 to develop and commercialize pharmaceutical products. Under the terms of the agreement, the alliance includes product candidates arising from Infinity's Hedgehog pathway, PI3K and all discovery programs. Mundipharma is obligated to fund all research and development costs of these programs within the strategic alliance, up to caps of $85 million in 2011 and $110 million in 2012. Infinity retains U.S. commercialization rights for these products and is entitled to receive royalties on any product sales outside the U.S. In addition, under the terms of the alliance related to Infinity's fatty acid amide hydrolase (FAAH) program, Purdue and Mundipharma are responsible for fully funding the FAAH program and Infinity is entitled to worldwide royalties on any successfully developed products.
Under the original agreement, Mundipharma has the right to opt out of any discovery project or any preclinical or clinical development program on an annual basis in November of each year. In the event of an opt-out decision, Mundipharma will continue to provide funding for, in the aggregate, 100 percent of Infinity's contractually budgeted research and development expenses for all programs included in the alliance for the calendar year following the date of such opt out. Under the amended agreement, these time-based decisions have been modified to become event-based for the Hedgehog program. Mundipharma's next funding commitment will be within 30 days following the outcome of Infinity's end-of-Phase 2 meeting with the FDA pertaining to the study of IPI-926 in patients with pancreatic cancer. Mundipharma will continue to fully fund the Hedgehog program through the latter of the end of 2012 or 30 days after the FDA meeting is held, at which point Mundipharma will make a decision about future funding commitments.
If Mundipharma elects to opt out of continued development funding following the end-of-Phase 2 meeting, Mundipharma would be obligated to make an immediate payment of approximately $24 million to Infinity, which Infinity can use on any research or development program in the alliance. In addition, Mundipharma would reimburse Infinity for up to approximately $24 million of additional expenses incurred during 2013 that are associated with the completion of Phase 2 trials of IPI-926 ongoing at the time of the opt-out, so that aggregate residual funding could total approximately $47 million.
Except for the timing and implications of future program funding decisions for IPI-926, the strategic alliance agreement remains unchanged.
About the Hedgehog Pathway and IPI-926
Malignant activation of the Hedgehog pathway is responsible for a broad range of cancers through three distinct mechanisms: signaling to the tumor microenvironment, signaling to tumor progenitor cells, and genetic activation of the Hedgehog pathway in tumor cells. IPI-926 is a small molecule that inhibits Smoothened (Smo), a key component of the Hedgehog pathway. Smo inhibition represents a significant anti-cancer opportunity for addressing a number of difficult-to-treat cancers by disrupting malignant activation of the pathway.
IPI-926 is currently being evaluated in a Phase 1 study in solid tumors as well as a Phase 1b/2 study in combination with Gemzar® (gemcitabine) in patients with previously untreated, metastatic pancreatic cancer. These clinical trials build upon a robust set of supporting preclinical data that provide a strong rationale for evaluating the potential of IPI-926 for treatment of a broad range of cancers.
About Infinity Pharmaceuticals, Inc.
Infinity is an innovative drug discovery and development company seeking to discover, develop, and deliver to patients best-in-class medicines for difficult-to-treat diseases. Infinity combines proven scientific expertise with a passion for developing novel small molecule drugs that target emerging disease pathways. Infinity's programs in the inhibition of the Hsp90 chaperone system, the Hedgehog pathway, fatty acid amide hydrolase, and phosphoinositide-3-kinase are evidence of its innovative approach to drug discovery and development. For more information on Infinity, please refer to the company's website at http://www.infi.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding the timing of future program funding decisions by Mundipharma, the commercial potential of Infinity's product portfolio, including the potential of IPI-926 in pancreatic and other cancers, and the successful completion of Phase 2 development of IPI-926 in pancreatic cancer. Further, there can be no guarantee that the company's strategic alliance with Mundipharma will continue as planned, or that any positive developments in Infinity's product portfolio will result in stock price appreciation. In particular, management's expectations could be affected by risks and uncertainties relating to: results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; the content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities and investigational review boards at clinical trial sites; the ability to enroll patients in clinical trials of IPI-926; unplanned cash requirements and expenditures; and Infinity's ability to obtain, maintain, and enforce patent and other intellectual property protection for any product candidates it is developing. These and other risks which may impact management's expectations are described in greater detail under the caption "Risk Factors" included in Infinity's quarterly report on Form 10-Q filed with the Securities and Exchange Commission on November 9, 2010. Further, any forward-looking statements contained in this press release speak only as of the date hereof, and Infinity expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise.
Gemzar® is a registered trademark of Eli Lilly and Company.