Infinity Pharmaceuticals, Purdue Pharmaceutical Products, and Mundipharma International have restructured their existing drug development alliance and passed back to Infinity global rights to the firm’s phosphoinositide-3-kinase (PI3K) program, its fatty acid amide hydrolase (FAAH) program, and early-stage discovery projects. The alliance, centered on the development of product candidates arising from Infinity's PI3K and other discovery programs, was originally signed in 2008.
As part of the restructuring Purdue will make a $27.5 million equity investment in Infinity, through the purchase of nearly 2 million shares of Infinity common stock at $14.50 per share. Infinity will also issue Purdue with another 3,520,013 shares of its common stock, at the same price, to pay back the principal and accrued interest outstanding under a $50 million line of credit Purdue made available to Infinity.
The pass-back of drug programs to Infinity means Mundipharma will no longer provide the firm with research and development funding. Mundipharma and Purdue will, however, be entitled to receive royalties on sales of products that were previously encompassed by the partnership. Under the original agreement Mundipharma was to fund all research and development costs within the strategic alliance through at least 2013, up to caps of $85 million in 2011 and $110 million in 2012. Purdue and Mundipharma were separately responsible for fully funding the FAAH program, with Infinity retaining an entitlement to worldwide royalties of up to 20% on any successfully developed products.
“Regaining worldwide rights to all of our programs, particularly our PI3K program, is an important, value-creating development for Infinity,” comments Adelene Q. Perkins, president and CEO. “Our strategic alliance with Mundipharma and Purdue has been key in building the company, and we are pleased that they will now participate in the value of our PI3K program as a more significant Infinity equity holder, together with our other investors.”
Infinity’s lead PI3K-delta and gamma inhibitor IPI-145 is currently undergoing Phase I testing in patients with advanced hematological malignancies. The firm also today announced expanding the study in patients with chronic lymphocytic leukemia, indolent non-Hodgkin lymphoma, or mantle cell lymphoma. Phase II development of IPI-145 as a treatment for inflammation is expected to begin in the second half of 2012.
Infinity’s lead candidate, retaspimycin hydrochloride (IPI-504), is an intravenously administered, selective heat shock protein 90 (Hsp90) inhibitor. A Phase II placebo-controlled trial is currently in progress to evaluate the antitumor activity, tolerability, and safety of retaspimycin HCl in combination with docetaxel in approximately 200 second- or third- line non-small cell lung cancer (NSCLC) patients. A previously completed Phase Ib trial demonstrated that treatment using retaspimycin HCl in combination with docetaxel was well-tolerated and clinically active in heavily pretreated patients with NSCLC. A Phase Ib/II trial is separately under way to evaluate retaspimycin HCl in combination with everolimus (Afinitor®) as a treatment for NSCLC patients with a KRAS mutation.