HedgePath Pharma Targets Q1 2019 for New Drug Application for Basal Cell Carcinoma Nevus Syndrome Drug Candidate

In its quest to get SUBA-Itraconazole through the U.S. Food and Drug Administration as a new treatment for Basal Cell Carcinoma in patients with Basal Cell Carcinoma Nevus Syndrome (BCCNS), HedgePath Pharmaceuticals (OTCQB:HPPI) said Tuesday it has moved a step closer to getting a New Drug Application (NDA) up for consideration at the regulatory agency.

After reviewing minutes from a face-to-face meeting with FDA officials held late in September, the Tampa-based company sees a path forward to get the FDA what it wants.

More than four million cases of Basal Cell Carcinoma (BCC) are diagnosed each year in the United States, with Mohs surgery recognized as the single most effective technique to remove the cancerous cells.

Basal Cell Carcinoma Nevus Syndrome (BCCNS), which goes by several names, including Gorlin syndrome, refers to a group of defects caused by a rare genetic condition, with BCC after puberty a telltale sign of the malady. In the disease, an inherited defect in the hedgehog pathway allows for hundreds, or even thousands, of basal cell carcinomas to develop throughout a patient's lifetime.

HedgePath is developing SUBA-Itraconazole through a license agreement with Mayne Pharma (the majority shareholder of HPPI) and under an FDA Orphan Drug Designation, which provides specific benefits for companies developing drugs for diseases and conditions that affect less than 200,000 Americans.

It's estimated that there are 10,000 people in the U.S. with BCCNS, with limited treatment options given that there are no FDA-approved drugs for the indication. Itraconazole is an anti-fungal drug that has been used for nearly three decades, but the patented formulation being used by HedgePath is novel - with far superior bioavailability than the generic - for the indication and potentially other cancerous and non-cancerous conditions.

HedgePath and the FDA have agreed on eight of 11 NDA requirements for the drug candidate, with the meeting providing clarity on the other three. If HedgePath complies with the FDA's wishes, which include updating some information and an Integrated Safety Summary (ISS) amongst other things, the FDA will accept the NDA for consideration of marketing approval.

The challenge for HedgePath is the ISS insomuch as management says it will be sometime during the first quarter of 2019 for the completed NDA to be submitted to the FDA.

That time frame is in conflict with a December 31, 2018 deadline per the license agreement with Mayne, which leaves Mayne the option to take back the U.S. rights to SUBA-Itraconazole for BCCNS (including by way of an exclusive license from HPPI of its clinical data) in exchange for a royalty on any future net sales.

HedgePath says that it is in negotiations with Mayne about the situation.

Shares of HPPI have essentially been rangebound between 25 cents and 35 cents for the last year. Early in afternoon trading on Tuesday, the thinly-traded stock is up 0.36% at 28.21 cents.