HedgePath Pharmaceuticals (HPPI) signed an exclusive supply and license agreement with Australia-based firm Mayne Pharma International, whereby HPPI will pursue clinical development of Mayne Pharma's formulation of the drug itraconazole, known as SUBA-Itraconazole, for treatment of a range of cancers. The focus is on seeking regulatory approvals and marketing in the United States for the formulation. HPPI is currently planning to repurpose itraconazole, which is already approved by the FDA as a treatment for fungal infections in other formulations now off-patent, as a potential treatment for cancer.
Per the agreement, HPPI will be supplied specially formulated capsules of SUBA-Itraconazole, manufactured by Mayne Pharma, for HPPI's use in future clinical trials and also for the future commercial supply following FDA approvals, if said approvals are obtained. HPPI and Mayne Pharma will collaborate through a joint development program for SUBA-Itraconazole for multiple oncology indications. HPPI has been granted exclusive rights to SUBA-Itraconazole for treatment of cancer in the United States, and Mayne Pharma is retaining its rights for use of the drug outside the United States, including a license from HPPI for current and future developments of anticancer therapies using SUBA-Itraconazole.
"SUBA technology," which stands for "super bioavailability," is designed to improve the bioavailability of orally administered drugs that are poorly soluble. SUBA-Itraconazole is a formulation that Mayne Pharma says has improved absorption and significantly reduced variability compared to generic itraconazole.
"This agreement is more than just a supply agreement," Nicholas J. Virca, HPPI's president and CEO, said in a statement. "It jumpstarts our business plan by giving us access to the key technology we need to progress our clinical development programs forward and, if ultimately approved by the FDA, market our anticancer therapies in the U.S. with exclusivity."