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HedgePath Pharmaceuticals Enters into Key Collaboration with Mayne Pharma
Date:9/10/2013

TAMPA, Fla. and SAN DIEGO, Sept. 10, 2013 /PRNewswire/ -- HedgePath Pharmaceuticals, Inc. (OTCPink: HPPI) (HPPI) announced today that it has signed an exclusive Supply and License Agreement with Mayne Pharma International Pty Ltd (Mayne Pharma), a wholly owned subsidiary of Mayne Pharma Group Limited, an Australian ASX listed company, whereby HPPI will pursue clinical development of Mayne Pharma's patented formulation of the drug itraconazole, known as SUBA-Itraconazole, for treatment of a variety of cancers with a focus on seeking regulatory approvals and marketing in the United States.

The agreement represents a significant step forward for HPPI in the progression of its business plan of repurposing itraconazole as a potential treatment for cancer.  Itraconazole, in other formulations now off-patent, is already approved by the U.S. Food and Drug Administration (FDA) for human use as a treatment for fungal infections.

The agreement provides for the supply to HPPI of specially formulated capsules of SUBA-Itraconazole, manufactured by Mayne Pharma under cGMP (current good manufacturing practice) standards, for use by HPPI in its anticipated clinical trials, and for the future exclusive commercial supply following FDA approvals, if obtained. "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 patented formulation developed by Mayne Pharma, which has improved absorption and significantly reduced variability compared to generic itraconazole. These benefits provide enhancements to patients and prescribers with reduced intra- and inter-patient variability, enabling a more predictable clinical response and a reduction in the active drug quantity to deliver the required therapeutic blood levels.

HPPI and Mayne Pharma will collabo
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SOURCE HedgePath Pharmaceuticals, Inc.
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