Infinity and Mundipharma Extend Global Strategic Alliance
- Mundipharma Commits to Providing Over $50 Million in R&D Funding for Infinity's PI3K Inhibitor and Innovative Discovery Programs for 2013 -
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Infinity Pharmaceuticals, Inc. (Nasdaq: INFI) today announced that Mundipharma International Corporation Limited has committed to providing over $50 million in funding in 2013 for the continued development of IPI-145, Infinity's potent, oral inhibitor of phosphoinositide-3-kinase (PI3K) delta and gamma, as well as development candidates arising out of Infinity's innovative discovery programs. An extension of the companies' global strategic alliance, this funding reflects the broad commercial potential of IPI-145 in both hematologic cancers and inflammatory conditions as well as the continued productivity of Infinity's discovery and development programs.
"Mundipharma has been a wonderful partner, and we are pleased to continue our relationship as we work to bring important new medicines to patients."
"Mundipharma's substantial financial commitment to our PI3K and discovery programs through at least 2013 demonstrates our shared belief that, with key clinical events anticipated in 2012, we are building one of the broadest, deepest and most exciting pipelines of any clinical-stage company in oncology and inflammation," stated Adelene Q. Perkins, president and chief executive officer of Infinity. "Mundipharma has been a wonderful partner, and we are pleased to continue our relationship as we work to bring important new medicines to patients."
"Since our alliance began in 2008, Infinity has advanced and expanded its portfolio of innovative product candidates," said Antony Mattessich, regional director of Europe at Mundipharma. "Infinity's productivity and track record in achieving its development objectives make the company an ideal partner, and we look forward to an ongoing collaboration which we hope will yield multiple best-in-class treatments that address significant unmet medical needs."
IPI-145 targets PI3K-delta and gamma, two enzymes that are implicated in hematologic cancers as well as a broad range of inflammatory and autoimmune diseases. As the only PI3K delta/gamma inhibitor currently in clinical development, IPI-145 is distinct from other investigational drugs targeting PI3K and has significant potential in both hematologic cancers and inflammatory diseases.
"The unique profile of IPI-145 provides us potential first-in-class or best-in-class product opportunities in multiple indications. The potent activity of IPI-145 against both PI3K-delta and gamma could enable us to see clinical activity against a broad range of hematologic malignancies, including those that may not be suitable for a delta-specific PI3K inhibitor," said Vito J. Palombella, Ph.D., chief scientific officer at Infinity. "In addition, the role of PI3K-delta and gamma in the differentiation, maintenance, localization and activation of immune cells suggests that IPI-145 may have the potential to treat inflammatory diseases."
Infinity is currently conducting two Phase 1 clinical trials of IPI-145. The first trial, which is intended to facilitate Phase 2 clinical development of IPI-145 in inflammation, is a double-blind, randomized, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple escalating doses of IPI-145 in healthy adult subjects. The second trial is an open-label, dose-escalation study designed to evaluate the safety, pharmacokinetics and clinical activity of IPI-145 in patients with advanced hematologic malignancies. Following the determination of the maximum tolerated dose in the dose escalation phase, an expansion phase will follow in patients with selected hematologic malignancies. Data from both of these studies are expected in 2012.
Beyond IPI-145, Infinity is advancing a broad research program to identify additional novel, differentiated inhibitors of PI3K-delta and/or gamma for future development. In addition, Infinity maintains a robust discovery effort to fuel its future pipeline in emerging areas such as cancer metabolism, apoptosis, protein homeostasis and inflammation. Mundipharma has non-U.S. commercial rights to all existing discovery programs and any new discovery programs added to Infinity's portfolio before the end of 2013, subject to an obligation to fund Infinity's research and development costs for these programs up to the start of Phase 3 clinical development.
As part of its strategic alliance with Mundipharma and its independent associated company, Purdue Pharmaceutical Products L.P., a $50 million line of credit was made available to Infinity. Infinity announced today that it has drawn the full amount under this line of credit. This amount bears interest at the prime rate, and no principal or interest is repayable until April 1, 2019. In August 2011, Infinity announced that it planned to draw down the line of credit in its entirety prior to the end of 2011.
About the Mundipharma Alliance
In November 2008, Infinity entered into a strategic alliance with Mundipharma and Purdue to develop and commercialize pharmaceutical products. The alliance currently covers product candidates arising from Infinity's Hedgehog pathway, PI3K and early discovery programs. Infinity retains U.S. commercialization rights for these product candidates and is entitled to receive royalties from Mundipharma on any product sales outside of the U.S.
Mundipharma is obligated to fund all research and development costs for each of these programs up to the commencement of Phase 3 clinical development or, if later, through the end of 2013, subject to annual funding caps. The funding cap for calendar year 2012 is $110 million.
As announced today, Mundipharma is now committed to funding over $50 million in research and development for Infinity's PI3K and early discovery programs during 2013. The 2013 funding commitment for Infinity's Hedgehog inhibitor program will be determined following Infinity's end-of-Phase 2 meeting with the U.S. Food and Drug Administration pertaining to the study of IPI-926 in patients with pancreatic cancer.
In addition, in October 2010, Purdue and Mundipharma exercised their right to assume worldwide development and commercialization activities for Infinity's Phase 2-ready fatty acid amide hydrolase (FAAH) program. Infinity is entitled to royalties on any global sales of products arising from this program.
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 Hedgehog pathway, the Hsp90 chaperone system, phosphoinositide-3-kinase and fatty acid amide hydrolase are evidence of its innovative approach to drug discovery and development. For more information on Infinity, please refer to the company's website at 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 those regarding the therapeutic potential of inhibition of PI3K-delta and gamma, including the ability of IPI-145 to be first- and best-in-class, the timing for receipt of data from Infinity's ongoing clinical studies, the expectation of an expansion phase in the clinical trial of IPI-145 in patients with advanced hematologic malignancies, and the ability of Infinity to generate new development candidates out of its discovery programs. Such statements are subject to numerous factors, risks and uncertainties that may cause actual events or results to differ materially from the company's current expectations. For example, there can be no guarantee that IPI-145 will successfully complete necessary preclinical and clinical development phases or that Infinity's strategic alliance with Mundipharma International Corporation Limited will continue for its expected term or that it will fund Infinity's programs as agreed. Management's expectations could also 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, investigational review boards at clinical trial sites and publication review bodies; Infinity's ability to enroll patients in its clinical trials; unplanned cash requirements and expenditures, including in connection with business development activities; 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 8, 2011. 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.