Ongoing alliance focuses on cancer and inflammatory diseases.
Mundipharma International will put over $50 million into the continued development of partner Infinity Pharmaceuticals’ Phase I-stage oral phosphoinositide-3 kinase (PI3K) delta and gamma inhibitor IPI-145, and other candidates arising from the latter’s discovery programs. IPI-145 is being developed as a potential treatment for hematologic cancers and inflammatory diseases, and is currently in Phase I development in healthy adults and advanced hematologic malignancies.
The deal between the firms, through which Mundipharma will input the $50 million in funding during 2013, expands an existing alliance signed in November 2008, which is focused on developing and commercializing products emerging from Infinity’s Hedgehog pathway, PI3K, and early discovery programs. Under terms of the deal, Infinity retains U.S. commercialization rights to resulting drugs, and will receive royalties from Mundipharma on product sales outside the U.S. Mundipharma is responsible for funding all R&D costs associated with each program up to the start of Phase III clinical development or, if later, through the end of 2013, subject to funding caps. The funding cap for calendar year 2012 has been set at $110 million.
While Mundipharma’s funding commitment to the PI3K program is now agreed for 2013, the firms note that funding commitments for Infinity’s Hedgehog inhibitor program will be decided after its end-of-Phase II meeting with FDA, relating to the study of IPI-926 in patients with pancreatic cancer.
Mundipharma and associate company Purdue Pharmaceutical Products also have rights to assume worldwide development and commercialization activities for Infinity’s Phase II-ready fatty acid amide hydrolase (FAAH) program.
Infinity’s pipeline is headed by the Hedgehog pathway candidate IPI-926, which is in Phase II development either as monotherapy or combination therapy for the treatment of pancreatic cancer, myelofibrosis, chondrosarcoma, and solid tumors. The Hsp90 candidate retaspimycin HCL is in Phase I and II development in combination with docetaxel and everolimus, respectively, as a treatment for non-small cell lung cancer.